0A4F4F9BD490A749D5437F821CF06DF1

Resolution RDC No. 9, 14 March 2011

http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/prt0009_14_03_2011.html

http://leaux.net/URLS/ConvertAPI Text Files/1F38E5F2C5146C281735DC80C16E823D.en.txt

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Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Dependence	dependence	1
Health	HIV/AIDS	HIV	1
Health	Mentally Disabled	disabled	1
Health	Mentally Disabled	mentally	1
Health	Physically Disabled	physically	1
Health	stem cells	stem cells	14
Social	Access to Social Goods	access	6
Social	Age	age	1
Social	Linguistic Proficiency	language	1
Social	Marital Status	single	18
Social	Police Officer	officer	3
Social	education	education	4
Social	education	educational	2
Social	embryo	embryo	2
Social	employees	employees	5
Social	parents	parents	1
General/Other	Manipulable	manipulate	1
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	1

Health / Drug Dependence

Searching for indicator dependence:

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p.(None): perform its main function in human beings, being able, however, to be assisted in their functions by such means;
p.(None): b) product for diagnosis of in vitro use - reagents, standards, calibrators, controls, materials, articles and instruments,
p.(None): together with instructions for its use, which contribute to a qualitative, quantitative or semi-determination
p.(None): quantitative analysis of a sample from the human body and that are not intended to fulfill any anatomical function,
p.(None): physical or therapeutic, that are not ingested, injected or inoculated in humans and that are used only
p.(None): to provide information on samples obtained from the human organism;
p.(None): XXXIII- legally qualified professional: professional with higher education enrolled in the respective Board of Directors
p.(None): Class, with its powers attributed by Law;
p.(None): XXXIV- traceability: ability to retrieve the history, application or location of what is being
p.(None): considered, through registered identifications;
p.(None): XXXV- Technical Responsible (RT): legally qualified professional who assumes the technical responsibility of the CTC before
p.(None): health surveillance;
p.(None): XXXVI- room: an environment bounded by walls in all its perimeter and a door;
p.(None): XXXVII- therapy: any therapeutic process that uses human cells or their derivatives;
p.(None): XXXVIII- Informed Consent Form (ICF): consent form through which the research subject
p.(None): and / or their legal representative expressly agrees, authorizing their voluntary participation in the research, free from vices
p.(None): (simulation, fraud or error), dependence, subordination or intimidation, after a complete and detailed explanation of the
p.(None): nature of the research, its objectives, methods, expected benefits, potential risks and the discomfort it may cause;
p.(None): XXXIX- functional test: test that aims to verify and ensure the presence of functional and / or proliferative capacity of cells
p.(None): human beings and their derivatives;
p.(None): XL- microbiological test: test carried out according to current legislation, aiming at the detection of microbiological agents from
p.(None): a sample rate to be made available;
p.(None): XLI- pyrogenicity test: test that aims to check the presence of pyrogens in the sample of biological material;
p.(None): XLII- conventional hematopoietic progenitor cell transplantation: expression used to replace the expression
p.(None): "bone marrow transplant" to designate the type of cell therapy you use for the infusion of progenitor cells
p.(None): hematopoietic, in order to obtain a transient or permanent graft to correct a quantitative or qualitative defect
p.(None): bone marrow, or restore hematopoiesis after myeloablative chemotherapy for the treatment of various diseases;
p.(None): XLIII- allogeneic use: use in clinical research and / or therapy of cells and their derivatives from another individual
p.(None): (donor), related or not;
p.(None): XLIV-autologous use: use in clinical research and / or therapy of cells and their derivatives from the individual himself
p.(None): being transplanted (patient);
p.(None): XLV- validation: procedure that provides evidence that a system performs within specifications
p.(None): quality, in order to generate valid results;
p.(None): XLVI-barrier dressing room: dressing room that must have a washbasin and serve as a barrier to the processing room, in order to
...

Health / HIV/AIDS

Searching for indicator HIV:

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p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
p.(None): § 1 At any time during the process, the donor has the right to withdraw from the donation.
p.(None): § 2 In the case of a donor under the age of 18 or mentally disabled, the IC must be confirmed by the parents or
p.(None): legal responsible.
p.(None): Art. 41. The use of human cells and their derivatives for donation that does not fully meet the qualification criteria
p.(None): will depend on joint assessment and decision between the person responsible for clinical research and / or therapy, the medical team of the service where
p.(None): the cells and their derivatives, the donor and the recipient or their legal guardians will be applied.
p.(None): Art. 42. Exclusion criteria for the candidate to donate human cells for allogeneic use are:
p.(None): I- infection confirmed by the HIV-1/2 virus;
p.(None): II- non-reactive HBsAg test with anti-HBc reagent, except when the donor is anti-HBs reagent;
p.(None): III- HBsAg reagent test, except when the recipient is also HBsAg reagent;
p.(None): IV- anti-HCV reagent test, except when the recipient also presents a reagent test in the qualitative research of RNA-
p.(None): HCV;
p.(None): V- malignant neoplastic disease, except basal cell carcinoma of the skin and carcinoma "in situ" of the cervix;
p.(None): VI-irreversible clinical condition that puts the donor's health at risk;
p.(None): VII- ongoing pregnancy;
p.(None): VIII-reversible clinical condition that puts the donor's health at risk; as the criteria for temporary disqualification
p.(None): blood donation, according to specific legislation in force.
p.(None): § 1 Definitive criteria for the exclusion of donors of human cells and their derivatives for allogeneic use are considered
p.(None): conditions provided for in items I to VI of the "caput" of this article.
p.(None): § 2 Temporary exclusion criteria for donors of human cells and their derivatives for allogeneic use are considered
p.(None): notwithstanding the conditions provided for in items VII to VIII of the "caput" of this article.
p.(None): Section XI
p.(None): Collection
p.(None): Art. 43. The collection of biological material for further processing of human cells and their derivatives, whether for use
p.(None): allogeneic or autologous, must be performed by a professional duly trained for such activity.
p.(None): Art. 44. Collection must be carried out at the CTC itself or at a health care establishment that has a health license,
p.(None): when appropriate, the necessary aseptic conditions must be maintained.
...

Health / Mentally Disabled

Searching for indicator disabled:

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p.(None): Germinative (BCTG), as provided in Technical Regulation for the operation of BCTG.
p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
p.(None): donation, risks involved, laboratory tests, among others necessary for understanding and signing the informed consent form, which must be
p.(None): written in clear and comprehensible language for the layperson and should contain, when appropriate, the following items:
p.(None): I - information on the risks to the donor and benefits to the recipient of the donation;
p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
p.(None): § 1 At any time during the process, the donor has the right to withdraw from the donation.
p.(None): § 2 In the case of a donor under the age of 18 or mentally disabled, the IC must be confirmed by the parents or
p.(None): legal responsible.
p.(None): Art. 41. The use of human cells and their derivatives for donation that does not fully meet the qualification criteria
p.(None): will depend on joint assessment and decision between the person responsible for clinical research and / or therapy, the medical team of the service where
p.(None): the cells and their derivatives, the donor and the recipient or their legal guardians will be applied.
p.(None): Art. 42. Exclusion criteria for the candidate to donate human cells for allogeneic use are:
p.(None): I- infection confirmed by the HIV-1/2 virus;
p.(None): II- non-reactive HBsAg test with anti-HBc reagent, except when the donor is anti-HBs reagent;
p.(None): III- HBsAg reagent test, except when the recipient is also HBsAg reagent;
p.(None): IV- anti-HCV reagent test, except when the recipient also presents a reagent test in the qualitative research of RNA-
p.(None): HCV;
p.(None): V- malignant neoplastic disease, except basal cell carcinoma of the skin and carcinoma "in situ" of the cervix;
p.(None): VI-irreversible clinical condition that puts the donor's health at risk;
p.(None): VII- ongoing pregnancy;
p.(None): VIII-reversible clinical condition that puts the donor's health at risk; as the criteria for temporary disqualification
p.(None): blood donation, according to specific legislation in force.
p.(None): § 1 Definitive criteria for the exclusion of donors of human cells and their derivatives for allogeneic use are considered
p.(None): conditions provided for in items I to VI of the "caput" of this article.
...

Searching for indicator mentally:

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p.(None): March 2005, and clinical and laboratory screening information from the Cell and Tissue Bank must be obtained
p.(None): Germinative (BCTG), as provided in Technical Regulation for the operation of BCTG.
p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
p.(None): donation, risks involved, laboratory tests, among others necessary for understanding and signing the informed consent form, which must be
p.(None): written in clear and comprehensible language for the layperson and should contain, when appropriate, the following items:
p.(None): I - information on the risks to the donor and benefits to the recipient of the donation;
p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
p.(None): § 1 At any time during the process, the donor has the right to withdraw from the donation.
p.(None): § 2 In the case of a donor under the age of 18 or mentally disabled, the IC must be confirmed by the parents or
p.(None): legal responsible.
p.(None): Art. 41. The use of human cells and their derivatives for donation that does not fully meet the qualification criteria
p.(None): will depend on joint assessment and decision between the person responsible for clinical research and / or therapy, the medical team of the service where
p.(None): the cells and their derivatives, the donor and the recipient or their legal guardians will be applied.
p.(None): Art. 42. Exclusion criteria for the candidate to donate human cells for allogeneic use are:
p.(None): I- infection confirmed by the HIV-1/2 virus;
p.(None): II- non-reactive HBsAg test with anti-HBc reagent, except when the donor is anti-HBs reagent;
p.(None): III- HBsAg reagent test, except when the recipient is also HBsAg reagent;
p.(None): IV- anti-HCV reagent test, except when the recipient also presents a reagent test in the qualitative research of RNA-
p.(None): HCV;
p.(None): V- malignant neoplastic disease, except basal cell carcinoma of the skin and carcinoma "in situ" of the cervix;
p.(None): VI-irreversible clinical condition that puts the donor's health at risk;
p.(None): VII- ongoing pregnancy;
p.(None): VIII-reversible clinical condition that puts the donor's health at risk; as the criteria for temporary disqualification
p.(None): blood donation, according to specific legislation in force.
p.(None): § 1 Definitive criteria for the exclusion of donors of human cells and their derivatives for allogeneic use are considered
...

Health / Physically Disabled

Searching for indicator physically:

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p.(None): packaging, storage, quality control tests, des-carte, release for use and transportation of human cells and
p.(None): its derivatives aimed at the safety and quality of cells and its derivatives made available for clinical research and therapy.
p.(None): Section II
p.(None): Coverage
p.(None): Art. 3 This Resolution applies to all establishments, public or private, that carry out activities with cells
p.(None): and their derivatives for the purpose of clinical research and / or therapy.
p.(None): § 1 - Establishments that use human cells and their derivatives in basic research and
p.(None): pre-clinical.
p.(None): § 2 The collection, processing, testing, storage, transportation, quality control and human use of
p.(None): hematopoietic stem cells obtained from bone marrow, peripheral blood or cord blood and placental with purpose
p.(None): of conventional hematopoietic progenitor cell transplantation, must follow that determined by RDC No. 56 of 16 December
p.(None): 2010, of Anvisa, or the legislation that will replace it.
p.(None): § 3 The collection, transport, registration, processing, storage, disposal and release of germ cells,
p.(None): germinal tissues and human embryos for the purpose of assisted human reproduction must follow that determined by RDC No. 33
p.(None): of February 17, 2006, of Anvisa, or by the legislation that replaces it.
p.(None): Section III
p.(None): Definitions
p.(None): Art. 4 For the purposes of this Resolution, it is considered
p.(None): I- health permit / operating license / health license: document issued by the competent State health agency,
p.(None): Municipal or Federal District, which authorizes the operation of establishments that carry out activities under the
p.(None): health surveillance;
p.(None): II- environment: a physically determined and specialized space for the development of a specific activity (ies),
p.(None): characterized by different dimensions and facilities, which may consist of a room or an area;
p.(None): III- ante-chamber: area adjacent to the processing room that guarantees the exclusive access of people to it.
p.(None): IV-human application: use of tissues or cells, including their derivatives, as application, infusion, implant or
p.(None): transplantation into a human recipient;
p.(None): V-area: open environment, without walls on one or more of one of the faces;
p.(None): VI- Germ Cell and Tissue Bank (BCTG): health service designed to select, collect, transport, record,
p.(None): process, store, discard and release cells, germ tissues and embryos, for own use or donation;
p.(None): VII- biosafety: security condition achieved by a set of actions aimed at preventing, controlling, reducing or
p.(None): eliminate risks inherent in activities that may compromise human, animal health and the environment;
p.(None): VIII- cell count: determination of the total number of nucleated cells by manual or automated system, validated
p.(None): and recorded in written and updated instructions;
p.(None): IX- somatic cells: differentiated adult cells;
p.(None): X- human stem cell: cell of human origin that has the ability to self-renew for long periods of time
p.(None): time and differentiate when receiving specific stimuli;
p.(None): XI- adult stem cells (CTA): stem cells originated from different organs and tissues, after the birth of the
p.(None): individual (post partum), including extra-embryonic attachments (placenta and umbilical cord);
...

Health / stem cells

Searching for indicator stem cells:

Searching for indicator access:

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p.(None): and their derivatives for the purpose of clinical research and / or therapy.
p.(None): § 1 - Establishments that use human cells and their derivatives in basic research and
p.(None): pre-clinical.
p.(None): § 2 The collection, processing, testing, storage, transportation, quality control and human use of
p.(None): hematopoietic stem cells obtained from bone marrow, peripheral blood or cord blood and placental with purpose
p.(None): of conventional hematopoietic progenitor cell transplantation, must follow that determined by RDC No. 56 of 16 December
p.(None): 2010, of Anvisa, or the legislation that will replace it.
p.(None): § 3 The collection, transport, registration, processing, storage, disposal and release of germ cells,
p.(None): germinal tissues and human embryos for the purpose of assisted human reproduction must follow that determined by RDC No. 33
p.(None): of February 17, 2006, of Anvisa, or by the legislation that replaces it.
p.(None): Section III
p.(None): Definitions
p.(None): Art. 4 For the purposes of this Resolution, it is considered
p.(None): I- health permit / operating license / health license: document issued by the competent State health agency,
p.(None): Municipal or Federal District, which authorizes the operation of establishments that carry out activities under the
p.(None): health surveillance;
p.(None): II- environment: a physically determined and specialized space for the development of a specific activity (ies),
p.(None): characterized by different dimensions and facilities, which may consist of a room or an area;
p.(None): III- ante-chamber: area adjacent to the processing room that guarantees the exclusive access of people to it.
p.(None): IV-human application: use of tissues or cells, including their derivatives, as application, infusion, implant or
p.(None): transplantation into a human recipient;
p.(None): V-area: open environment, without walls on one or more of one of the faces;
p.(None): VI- Germ Cell and Tissue Bank (BCTG): health service designed to select, collect, transport, record,
p.(None): process, store, discard and release cells, germ tissues and embryos, for own use or donation;
p.(None): VII- biosafety: security condition achieved by a set of actions aimed at preventing, controlling, reducing or
p.(None): eliminate risks inherent in activities that may compromise human, animal health and the environment;
p.(None): VIII- cell count: determination of the total number of nucleated cells by manual or automated system, validated
p.(None): and recorded in written and updated instructions;
p.(None): IX- somatic cells: differentiated adult cells;
p.(None): X- human stem cell: cell of human origin that has the ability to self-renew for long periods of time
p.(None): time and differentiate when receiving specific stimuli;
p.(None): XI- adult stem cells (CTA): stem cells originated from different organs and tissues, after the birth of the
p.(None): individual (post partum), including extra-embryonic attachments (placenta and umbilical cord);
p.(None): XII- embryonic stem cells (CTE): pre-implantation embryo cells that have the ability to transform
p.(None): in cells of any tissue of an organism;
p.(None): XIII- induced pluripotent stem cells (CTPi): cells created from reprogramming somatic cells, CTA or
...

p.(None): nature of the research, its objectives, methods, expected benefits, potential risks and the discomfort it may cause;
p.(None): XXXIX- functional test: test that aims to verify and ensure the presence of functional and / or proliferative capacity of cells
p.(None): human beings and their derivatives;
p.(None): XL- microbiological test: test carried out according to current legislation, aiming at the detection of microbiological agents from
p.(None): a sample rate to be made available;
p.(None): XLI- pyrogenicity test: test that aims to check the presence of pyrogens in the sample of biological material;
p.(None): XLII- conventional hematopoietic progenitor cell transplantation: expression used to replace the expression
p.(None): "bone marrow transplant" to designate the type of cell therapy you use for the infusion of progenitor cells
p.(None): hematopoietic, in order to obtain a transient or permanent graft to correct a quantitative or qualitative defect
p.(None): bone marrow, or restore hematopoiesis after myeloablative chemotherapy for the treatment of various diseases;
p.(None): XLIII- allogeneic use: use in clinical research and / or therapy of cells and their derivatives from another individual
p.(None): (donor), related or not;
p.(None): XLIV-autologous use: use in clinical research and / or therapy of cells and their derivatives from the individual himself
p.(None): being transplanted (patient);
p.(None): XLV- validation: procedure that provides evidence that a system performs within specifications
p.(None): quality, in order to generate valid results;
p.(None): XLVI-barrier dressing room: dressing room that must have a washbasin and serve as a barrier to the processing room, in order to
p.(None): ensure the access of professionals wearing clothes for exclusive use; and
p.(None): XLVII-cell viability: determination of the total number of live nucleated cells by means of a manual or
p.(None): automated, validated and recorded in written and updated instructions.
p.(None): Chapter II
p.(None): General Aspects
p.(None): Art. 5 The Cellular Technology Centers are responsible for all procedures related to the preparation of cells
p.(None): and their derivatives, for use in clinical research and / or therapy, including collection, processing, packaging,
p.(None): storage, cell quality control tests, disposal, release for use and transportation.
p.(None): Single paragraph. The activities listed in the caput are, as a rule, exclusive to the CTC, allowing outsourcing, however,
p.(None): collection activities only, laboratory screening tests, cell quality control tests and transport
p.(None): Art. 6 If the CTC conducts basic or pre-clinical research, these must be carried out in separate rooms from where they are
p.(None): processing and manipulation of human cells and their derivatives for use in clinical research and / or therapy
p.(None): Single paragraph. The rooms must be willing to allow the circulation of people with independent streams of materials,
p.(None): people and products for diagnosis of in vitro use, biological material, waste, so that there is no crossing of flows between
p.(None): the basic and preclinical research rooms and the clinical and / or therapy research rooms.
p.(None): Article 7 Human cells and their derivatives may only be made available for clinical research and / or therapy by CTCs,
p.(None): through proof of approval of clinical research by the CEP / CONEP system or proof that the procedure
...

p.(None): for consult.
p.(None): Art. 32. A daily record of the condition of equipment, refrigerators, freezers or storage tanks must be maintained.
p.(None): storage, documenting temperature, CO2 level (for incubator) and nitrogen level.
p.(None): § 1 The verification and recording of temperature and CO2 level, when applicable, must be carried out at defined intervals
p.(None): by the CTC for equipment that does not have an automatic recorder.
p.(None): § 2 The records must be signed and periodically reviewed by a qualified person.
p.(None): § 3 The alarms must be tested.
p.(None): §4º There must be a written procedure, defining the conduct to be taken in relation to the storage of samples if
p.(None): there is a defect in the storage equipment.
p.(None): § 5 The volume of liquid nitrogen in the reservoirs must be controlled and recorded at the frequency defined by the CTC.
p.(None): Section IX
p.(None): Minimum physical infrastructure
p.(None): Art. 33. The physical infrastructure of the CTC must, as appropriate, comply with the provisions of the technical regulation for planning,
p.(None): programming, elaboration and evaluation of physical projects of health care establishments, approved by RDC Anvisa nº
p.(None): 50, of February 21, 2002, or whatever replaces it, as well as the specific requirements contained in this Resolution and others
p.(None): current rules.
p.(None): Single paragraph. The CTC must have an emergency electricity system, as provided for in RDC Anvisa nº 50, of 21
p.(None): February 2002, or the one that replaces it, and must also observe the equipment manufacturer's instructions regarding
p.(None): requirements for using UPSs.
p.(None): Art. 34. The physical infrastructure of the CTC must be of exclusive use and access for such purpose, and must consist of
p.(None): environments in a layout that allows circulation with an independent flow of inputs, biological material, professionals and waste,
p.(None): allowing cleaning and maintenance, with the purpose of guaranteeing the quality of human cells and their derivatives in all
p.(None): stages of the process.
p.(None): Art. 35. The construction, renovation or adaptation in the physical structure of the CTC must be preceded by the approval of the project with the
p.(None): local health authority.
p.(None): Art. 36. The CTC must carry out microbiological control of its environments, equipment (CO2 incubator) and culture media,
p.(None): when it fits.
p.(None): § 1 In case there is manipulation of the culture media (aliquot, addition of components) previously registered or
p.(None): registered by Anvisa, their microbiological control must be performed.
p.(None): § 2 The microbiological control of the environments and the CO2 incubator must be carried out at defined time intervals
p.(None): by CTC, depending on the workflow.
p.(None): Section X
p.(None): Donor and / or patient selection
p.(None): Art. 37. The donation of human cells for use in clinical research or therapy must respect the legal and ethical precepts on the
p.(None): subject, ensuring confidentiality, non-perception of remuneration or direct benefit, and the Free and
p.(None): Informed Consent Form (TCLE), according to current legislation.
p.(None): Art. 38. To obtain human cells, whether for autologous or for allogeneic use, the CTC must perform clinical and
p.(None): laboratory.
p.(None): Single paragraph. Laboratory screening should follow that determined for blood donation, according to current legislation.
p.(None): Art. 39. To obtain embryos or embryonic stem cells, the criteria of Law No. 11,105, of 24
p.(None): March 2005, and clinical and laboratory screening information from the Cell and Tissue Bank must be obtained
p.(None): Germinative (BCTG), as provided in Technical Regulation for the operation of BCTG.
p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
p.(None): donation, risks involved, laboratory tests, among others necessary for understanding and signing the informed consent form, which must be
p.(None): written in clear and comprehensible language for the layperson and should contain, when appropriate, the following items:
p.(None): I - information on the risks to the donor and benefits to the recipient of the donation;
p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
p.(None): § 1 At any time during the process, the donor has the right to withdraw from the donation.
p.(None): § 2 In the case of a donor under the age of 18 or mentally disabled, the IC must be confirmed by the parents or
p.(None): legal responsible.
p.(None): Art. 41. The use of human cells and their derivatives for donation that does not fully meet the qualification criteria
p.(None): will depend on joint assessment and decision between the person responsible for clinical research and / or therapy, the medical team of the service where
p.(None): the cells and their derivatives, the donor and the recipient or their legal guardians will be applied.
p.(None): Art. 42. Exclusion criteria for the candidate to donate human cells for allogeneic use are:
p.(None): I- infection confirmed by the HIV-1/2 virus;
p.(None): II- non-reactive HBsAg test with anti-HBc reagent, except when the donor is anti-HBs reagent;
p.(None): III- HBsAg reagent test, except when the recipient is also HBsAg reagent;
...

p.(None): § 2 The collection report must contain, at least, the following information:
p.(None): I- name of the patient donor;
p.(None): II- Clinical and laboratory data;
p.(None): III- date and time of collection;
p.(None): IV- responsible for the collection;
p.(None): V- description of the procedure;
p.(None): VI- storage temperature of biological material for transportation;
p.(None): VII- result of serological tests, if any; and
p.(None): VIII- Informed Consent Form.
p.(None): Section XII
p.(None): Processing and Storage
p.(None): Art. 48. All human biological material, being potentially infectious, must be handled in accordance with the
p.(None): biosafety requirements.
p.(None): Art. 49. All processing steps must be described in written and updated instructions, with protocols
p.(None): defined and validated, and must meet the specifications described in this Resolution.
p.(None): Art. 50. Processing protocols must prevent cross-contamination and material exchange.
p.(None): Art. 51. The simultaneous processing of human cells and their derivatives from more than one donor / patient in the
p.(None): same environment.
p.(None): Art. 52. The CTC must ensure cleanliness and asepsis in the processing room and its equipment at each processing.
p.(None): Art. 53. The handling and exposure of biological material and materials, reagents and products for in vitro diagnosis during
p.(None): processing must take place exclusively in an environment classified as ISO 5 (Class 100).
p.(None): Art. 54. For CTC 1, the environment classified as ISO 5 (Class 100) must be installed in a room with classification
p.(None): minimum ISO 8 (Class 100,000)
p.(None): Single paragraph. CTC 1 must have a barrier dressing room to access the room where the biological material will be processed,
p.(None): washbasin and dressing area.
p.(None): Art. 55. For CTC 2, the environment classified as ISO 5 (Class 100) must be installed in a room with classification
p.(None): minimum ISO 7 (Class 10,000).
p.(None): Sole paragraph: CTC 2, must have an ante-chamber and barrier dressing room equipped with a washbasin and a dressing area in the
p.(None): access to the room where biological material will be processed.
p.(None): Art. 56. All biological materials that are submitted to the process of cultivation, extensive manipulation or cryopreservation
p.(None): prior to their use in cell therapy, they must have a representative sample cryopreserved and stored in the same
p.(None): conditions, intended for use in process quality control tests.
p.(None): Single paragraph. The number of samples prepared must be sufficient to carry out quality control tests
p.(None): necessary to release the use of biological material, according to article 60 of this Resolution, and for future quality control, if
p.(None): complementary analyzes are needed.
p.(None): Art. 57. Storage must be carried out under controlled conditions that guarantee the maintenance of the characteristics
p.(None): cells.
p.(None): Art. 58. If the CTC has a system for storing cell units in liquid nitrogen tanks, or if there is a
p.(None): nitrogen safety system for a mechanical freezer with a temperature of minus 150 ° C or less, the
p.(None): cryopreservation and storage must have:
p.(None): I- external visualization of its interior;
p.(None): II-mechanical exhaustion system, for dilution of residual nitrogen traces, which promotes forced exhaustion of the entire
p.(None): air from the cryopreservation and storage room, with discharge to the building's external environment;
p.(None): III- environmental oxygen level sensor with audible and visual alarms, inside and outside the cryopreservation room and
p.(None): storage;
p.(None): IV- audible and visual alarms, internal and external to the cryopreservation and storage room, which alert to possible failures
p.(None): in the supply of liquid nitrogen and / or storage equipment; and
p.(None): V- thermometer for monitoring environmental temperature, indicating maximum and minimum values.
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p.(None): registered by Anvisa, their microbiological control must be performed.
p.(None): § 2 The microbiological control of the environments and the CO2 incubator must be carried out at defined time intervals
p.(None): by CTC, depending on the workflow.
p.(None): Section X
p.(None): Donor and / or patient selection
p.(None): Art. 37. The donation of human cells for use in clinical research or therapy must respect the legal and ethical precepts on the
p.(None): subject, ensuring confidentiality, non-perception of remuneration or direct benefit, and the Free and
p.(None): Informed Consent Form (TCLE), according to current legislation.
p.(None): Art. 38. To obtain human cells, whether for autologous or for allogeneic use, the CTC must perform clinical and
p.(None): laboratory.
p.(None): Single paragraph. Laboratory screening should follow that determined for blood donation, according to current legislation.
p.(None): Art. 39. To obtain embryos or embryonic stem cells, the criteria of Law No. 11,105, of 24
p.(None): March 2005, and clinical and laboratory screening information from the Cell and Tissue Bank must be obtained
p.(None): Germinative (BCTG), as provided in Technical Regulation for the operation of BCTG.
p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
p.(None): donation, risks involved, laboratory tests, among others necessary for understanding and signing the informed consent form, which must be
p.(None): written in clear and comprehensible language for the layperson and should contain, when appropriate, the following items:
p.(None): I - information on the risks to the donor and benefits to the recipient of the donation;
p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
p.(None): § 1 At any time during the process, the donor has the right to withdraw from the donation.
p.(None): § 2 In the case of a donor under the age of 18 or mentally disabled, the IC must be confirmed by the parents or
p.(None): legal responsible.
p.(None): Art. 41. The use of human cells and their derivatives for donation that does not fully meet the qualification criteria
p.(None): will depend on joint assessment and decision between the person responsible for clinical research and / or therapy, the medical team of the service where
p.(None): the cells and their derivatives, the donor and the recipient or their legal guardians will be applied.
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p.(None): WARNING
p.(None): This text does not replace the one published in the Federal Official Gazette
p.(None): Ministry of Health
p.(None): National Health Surveillance Agency
p.(None): RESOLUTION No. 9, OF MARCH 14, 2011
p.(None): Provides for the operation of Technology Centers
p.(None): Cell phone for clinical research and therapy purposes and gives other
p.(None): measures.
p.(None): The Collegiate Directorate of the National Health Surveillance Agency in the use of the powers conferred on it by item IV of art. 11 of
p.(None): Regulation approved by Decree No. 3,029, of April 16, 1999, and in view of the provisions of item II and §§ 1 and 3 of Art.
p.(None): 54 of the Internal Regulation approved under the terms of Annex I of Ordinance No. 354 of Anvisa, of August 11, 2006, republished in the DOU
p.(None): August 21, 2006, in a meeting held on March 3, 2011,
p.(None): It adopts the following Resolution of the Collegiate Board of Directors and I, Substitute Chief Executive Officer, determine its publication:
p.(None): Art. 1 This Resolution is approved, which establishes the minimum requirements for the functioning of
p.(None): Cellular Technology (CTC) of human cells and their derivatives for clinical research and / or therapy purposes.
p.(None): Single paragraph. For the purposes of this Resolution, somatic cells, germ cells,
p.(None): adult stem cells, embryonic stem cells and induced pluripotent stem cells.
p.(None): CHAPTER I
p.(None): INITIAL PROVISIONS
p.(None): Section I
p.(None): objective
p.(None): Art. 2 This Resolution aims to establish minimum technical and sanitary requirements for the collection, processing,
p.(None): packaging, storage, quality control tests, des-carte, release for use and transportation of human cells and
p.(None): its derivatives aimed at the safety and quality of cells and its derivatives made available for clinical research and therapy.
p.(None): Section II
p.(None): Coverage
p.(None): Art. 3 This Resolution applies to all establishments, public or private, that carry out activities with cells
p.(None): and their derivatives for the purpose of clinical research and / or therapy.
p.(None): § 1 - Establishments that use human cells and their derivatives in basic research and
p.(None): pre-clinical.
p.(None): § 2 The collection, processing, testing, storage, transportation, quality control and human use of
p.(None): hematopoietic stem cells obtained from bone marrow, peripheral blood or cord blood and placental with purpose
p.(None): of conventional hematopoietic progenitor cell transplantation, must follow that determined by RDC No. 56 of 16 December
p.(None): 2010, of Anvisa, or the legislation that will replace it.
p.(None): § 3 The collection, transport, registration, processing, storage, disposal and release of germ cells,
p.(None): germinal tissues and human embryos for the purpose of assisted human reproduction must follow that determined by RDC No. 33
...

p.(None): XLII- conventional hematopoietic progenitor cell transplantation: expression used to replace the expression
p.(None): "bone marrow transplant" to designate the type of cell therapy you use for the infusion of progenitor cells
p.(None): hematopoietic, in order to obtain a transient or permanent graft to correct a quantitative or qualitative defect
p.(None): bone marrow, or restore hematopoiesis after myeloablative chemotherapy for the treatment of various diseases;
p.(None): XLIII- allogeneic use: use in clinical research and / or therapy of cells and their derivatives from another individual
p.(None): (donor), related or not;
p.(None): XLIV-autologous use: use in clinical research and / or therapy of cells and their derivatives from the individual himself
p.(None): being transplanted (patient);
p.(None): XLV- validation: procedure that provides evidence that a system performs within specifications
p.(None): quality, in order to generate valid results;
p.(None): XLVI-barrier dressing room: dressing room that must have a washbasin and serve as a barrier to the processing room, in order to
p.(None): ensure the access of professionals wearing clothes for exclusive use; and
p.(None): XLVII-cell viability: determination of the total number of live nucleated cells by means of a manual or
p.(None): automated, validated and recorded in written and updated instructions.
p.(None): Chapter II
p.(None): General Aspects
p.(None): Art. 5 The Cellular Technology Centers are responsible for all procedures related to the preparation of cells
p.(None): and their derivatives, for use in clinical research and / or therapy, including collection, processing, packaging,
p.(None): storage, cell quality control tests, disposal, release for use and transportation.
p.(None): Single paragraph. The activities listed in the caput are, as a rule, exclusive to the CTC, allowing outsourcing, however,
p.(None): collection activities only, laboratory screening tests, cell quality control tests and transport
p.(None): Art. 6 If the CTC conducts basic or pre-clinical research, these must be carried out in separate rooms from where they are
p.(None): processing and manipulation of human cells and their derivatives for use in clinical research and / or therapy
p.(None): Single paragraph. The rooms must be willing to allow the circulation of people with independent streams of materials,
p.(None): people and products for diagnosis of in vitro use, biological material, waste, so that there is no crossing of flows between
p.(None): the basic and preclinical research rooms and the clinical and / or therapy research rooms.
p.(None): Article 7 Human cells and their derivatives may only be made available for clinical research and / or therapy by CTCs,
p.(None): through proof of approval of clinical research by the CEP / CONEP system or proof that the procedure
p.(None): therapeutic is authorized by the Federal Council of Medicine (CFM) or Federal Council of Dentistry (CFO).
p.(None): Art. 8 ° The CTC must present an operating license, sanitary license or sanitary license, updated and issued by the
p.(None): competent health surveillance agency, in accordance with the provisions of the sole paragraph of article 10 of Law no. 6,437, of August 20,
p.(None): 1977, except for complementary state or municipal legal provisions.
p.(None): Single paragraph. The health service that includes a CTC in its facilities may request the inclusion of the description of this
p.(None): activity on their operating license, health license or health permit, with the competent health surveillance
p.(None): deliberation on this request.
p.(None): CHAPTER III
p.(None): TECHNICAL PROVISIONS
p.(None): Section I
p.(None): Classification and Activities
p.(None): Art. 9º CTCs can be classified as:
p.(None): I - Type 1 CTC: establishment that performs activities only with adult human cells, autologous, fresh or
p.(None): cryopreserved, without culture, with only minimal handling for use in clinical research and / or therapy.
p.(None): II - Type 2 CTC: establishment that performs activities with embryonic or adult human stem cells, autologous or
p.(None): allogeneic, fresh or cryopreserved, with or without cultivation, with or without extensive manipulation for use in clinical research
p.(None): and / or therapy
p.(None): §1º CTC type 1 is only able to process or cryopreserve human cells and their derivatives collected for use in
p.(None): clinical research and / or therapy that are known not to require further expansion, only need minimal manipulation and
p.(None): which are undoubtedly for autologous use.
p.(None): §2º The activities carried out by CTC type 1 are:
p.(None): I - collect or guide the collection of biological material;
p.(None): II - cryopreserve and store adult human cells and their derivatives;
p.(None): III - receive and, when necessary, provide clinical and laboratory screening of the patient;
p.(None): IV - evaluate the quality of the biological material received or collected;
p.(None): V - process the biological material;
p.(None): VI - carry out or provide the necessary tests to release the material in accordance with article 60 of this Resolution;
...

p.(None): III - transport embryos and human embryonic stem cells;
p.(None): IV - receiving and storing embryos that were made available for clinical research and therapy;
p.(None): V - perform the induction for differentiation of embryonic stem cells;
p.(None): VI - perform the reprogramming of human cells to induced pluripotent cells (CTPi);
p.(None): VII- cryopreserve, store, manipulate and process embryonic human stem cells and CTPi;
p.(None): VIII- provide human cells and their derivatives for clinical research and / or therapy providing the necessary information,
p.(None): respecting the confidentiality of the donation; and
p.(None): IX-provide written guidance regarding the handling, packaging and validity of cells and their derivatives
p.(None): available for use in clinical research and / or therapy.
p.(None): Section II
p.(None): Internal Regulations
p.(None): Art. 10. The CTC must have an internal regulation that contains the following items:
p.(None): I - purpose;
p.(None): II - organization chart, describing the administrative and technical-scientific structure of the CTC, with definition of the legal responsible and the
p.(None): technical responsible (the functions of legal responsible and technical responsible can be exercised by the same professional);
p.(None): and
p.(None): III - nominal list, accompanied by the corresponding signature of all administrative and technical-scientific personnel,
p.(None): indicating the qualification, functions and responsibilities of the technical manager and other CTC professionals.
p.(None): Single paragraph. The maintenance and updating of the list provided for in item III of the caput are the responsibility of the technical responsible
p.(None): of the CTC.
p.(None): Section III
p.(None): From the Operational Technical Manual
p.(None): Art. 11. The CTC must have a Technical Operational Manual that defines in detail all the procedures for collection,
p.(None): processing, quality control, packaging, storage, release for use, transport and disposal of cells
p.(None): and their derivatives, in the form of written and updated instructions.
p.(None): Art. 12. The manual mentioned in the previous article must be accessible, at any time, to all employees and
p.(None): be present, in printed and electronic forms, in the respective sectors of the laboratory.
p.(None): Single paragraph. If the CTC uses the electronic form, there must be at least one printed copy available at the service.
p.(None): Art. 13. The manual must also:
p.(None): I - be reviewed annually and whenever there is any change;
p.(None): II- be signed and dated by the technical responsible of the CTC;
p.(None): III - indicate the professional responsible for each procedure;
p.(None): IV - contain the conducts in the face of non-conformities; and
p.(None): V - describe the biosafety rules to be followed by all employees.
p.(None): Section IV
p.(None): Administrative and Technical-Scientific Structure
p.(None): Art. 14. The CTC must have a professional team with training and qualification compatible with its activities.
p.(None): Art. 15. The CTC must keep training and qualification records of its professionals compatible with the functions available
p.(None): performed.
p.(None): Art. 16. The CTC should promote training and permanent education of its employees, keeping records of
p.(None): themselves.
p.(None): Art. 17. The technical responsibility must be the responsibility of a professional with a higher education degree, with a master's or doctorate in the area of
p.(None): health or biological sciences, and minimum experience of 5 (five) years in cellular and / or molecular biology and registered in the respective
p.(None): class council.
p.(None): §1º The CTC must have a substitute technical manager with the same professional qualification as the technical manager.
p.(None): §2º The time of master's and / or doctorate in the area of cellular and / or molecular biology may be counted as time of
p.(None): professional experience.
...

p.(None): carrying out internal quality control of the CTC; and
p.(None): VII - the implementation and maintenance of the traceability of all its processes.
p.(None): Art. 20. The CTC must have written and updated instructions for the technical routines implemented.
p.(None): Section VI
p.(None): Biosafety
p.(None): Art. 21. The CTC must keep updated and make available, to all employees, written instructions on biosafety,
p.(None): covering at least the following items:
p.(None): I - biological, chemical, physical, occupational and environmental safety standards and conducts;
p.(None): II -instructions for use for personal protective equipment (PPE) and collective protection equipment (EPC);
p.(None): III - procedures in case of accidents; and
p.(None): IV - handling of material transport and biological sample.
p.(None): Art. 22. The technical responsible for the CTC must document the level of biosafety of the environments and areas based on the
p.(None): procedures performed and equipment used, adopting compatible safety measures.
p.(None): Section VII
p.(None): Of Materials, Reagents and Products for Diagnosis of in vitro Use
p.(None): Art. 23. The materials, reagents and products for diagnosis of in vitro use used for collection, processing, tests
p.(None): laboratories, preservation and expansion of human stem cells and their derivatives must be regularized with Anvisa, in accordance
p.(None): according to the specific legislation in force.
p.(None): Art. 24. All materials, reagents and products for in vitro diagnosis used and which maintain contact with cells and
p.(None): their derivatives, must be sterile, pyrogenic, non-cytotoxic and, when applicable, for single use, as well as
p.(None): registered lot number and validity to ensure traceability.
p.(None): Single paragraph. For materials subject to processing there must be a cleaning and sterilization procedure
p.(None): validated in accordance with current legislation.
p.(None): Art. 25. Reagents prepared or aliquoted by the laboratory itself must be identified with a label containing: name,
p.(None): concentration, batch number (if applicable), date of preparation, identification of who prepared it (when applicable), expiration date,
p.(None): storage conditions, as well as information regarding potential risks.
p.(None): Single paragraph. Records of the preparation processes and quality control of the prepared reagents must be kept.
p.(None): Art. 26. The use of materials, reagents and products for diagnosis of in vitro use must respect the recommendations for use
p.(None): manufacturer, preservation conditions, storage and expiration dates, and their revalidation is not allowed after
p.(None): expiry.
p.(None): Art. 27. The CTC that uses its own methodologies - in house, must document them including at least:
p.(None): I - description of the stages of the process;
p.(None): II - the specification and approval system for materials, reagents and products for in vitro diagnostics, equipment
p.(None): and instruments;
p.(None): III - the validation system; and
p.(None): IV - the registration of the entire process.
p.(None): Art. 28. The use of products of animal origin must be avoided.
p.(None): §1º If products of animal origin are used, they must have a certificate of absence of infectious agents and
p.(None): contaminants.
p.(None): §2 For growth factors, measures of identity, purity and potency must be established to ensure
p.(None): reproducibility of cell culture characteristics.
p.(None): Section VIII
p.(None): Equipment
p.(None): Art. 29. The CTC must comply with the following requirements regarding equipment:
p.(None): I - have specific equipment and instruments and in the quantity necessary to meet your demand;
p.(None): II - maintain written and updated instructions regarding the use of the equipment available to sector employees, the
p.(None): which must be complemented by the manufacturer's manuals in Portuguese;
p.(None): III - maintain and implement a preventive and corrective maintenance program, containing an intervention schedule;
p.(None): IV - maintain the calibrated measuring equipment and the respective records; and
p.(None): V - keep records of the origin and series of the equipment used in order to guarantee traceability.
p.(None): Single paragraph. In the event described in item III of this article, all interventions performed on the equipment must be
p.(None): registered systematically, informing day, responsible for the intervention, description of the intervention and, in case of replacement of
p.(None): parts, list of replaced parts.
p.(None): Art. 30. The equipment and instruments used, national and imported, must be regularized with Anvisa, in accordance with
p.(None): current legislation.
p.(None): Art. 31. The spreadsheets to control the equipment's use and maintenance routines must be permanently available
p.(None): for consult.
p.(None): Art. 32. A daily record of the condition of equipment, refrigerators, freezers or storage tanks must be maintained.
p.(None): storage, documenting temperature, CO2 level (for incubator) and nitrogen level.
p.(None): § 1 The verification and recording of temperature and CO2 level, when applicable, must be carried out at defined intervals
p.(None): by the CTC for equipment that does not have an automatic recorder.
p.(None): § 2 The records must be signed and periodically reviewed by a qualified person.
p.(None): § 3 The alarms must be tested.
p.(None): §4º There must be a written procedure, defining the conduct to be taken in relation to the storage of samples if
p.(None): there is a defect in the storage equipment.
p.(None): § 5 The volume of liquid nitrogen in the reservoirs must be controlled and recorded at the frequency defined by the CTC.
p.(None): Section IX
p.(None): Minimum physical infrastructure
p.(None): Art. 33. The physical infrastructure of the CTC must, as appropriate, comply with the provisions of the technical regulation for planning,
p.(None): programming, elaboration and evaluation of physical projects of health care establishments, approved by RDC Anvisa nº
p.(None): 50, of February 21, 2002, or whatever replaces it, as well as the specific requirements contained in this Resolution and others
p.(None): current rules.
p.(None): Single paragraph. The CTC must have an emergency electricity system, as provided for in RDC Anvisa nº 50, of 21
p.(None): February 2002, or the one that replaces it, and must also observe the equipment manufacturer's instructions regarding
p.(None): requirements for using UPSs.
p.(None): Art. 34. The physical infrastructure of the CTC must be of exclusive use and access for such purpose, and must consist of
p.(None): environments in a layout that allows circulation with an independent flow of inputs, biological material, professionals and waste,
p.(None): allowing cleaning and maintenance, with the purpose of guaranteeing the quality of human cells and their derivatives in all
p.(None): stages of the process.
p.(None): Art. 35. The construction, renovation or adaptation in the physical structure of the CTC must be preceded by the approval of the project with the
p.(None): local health authority.
p.(None): Art. 36. The CTC must carry out microbiological control of its environments, equipment (CO2 incubator) and culture media,
p.(None): when it fits.
p.(None): § 1 In case there is manipulation of the culture media (aliquot, addition of components) previously registered or
p.(None): registered by Anvisa, their microbiological control must be performed.
p.(None): § 2 The microbiological control of the environments and the CO2 incubator must be carried out at defined time intervals
p.(None): by CTC, depending on the workflow.
p.(None): Section X
p.(None): Donor and / or patient selection
p.(None): Art. 37. The donation of human cells for use in clinical research or therapy must respect the legal and ethical precepts on the
p.(None): subject, ensuring confidentiality, non-perception of remuneration or direct benefit, and the Free and
p.(None): Informed Consent Form (TCLE), according to current legislation.
p.(None): Art. 38. To obtain human cells, whether for autologous or for allogeneic use, the CTC must perform clinical and
p.(None): laboratory.
p.(None): Single paragraph. Laboratory screening should follow that determined for blood donation, according to current legislation.
p.(None): Art. 39. To obtain embryos or embryonic stem cells, the criteria of Law No. 11,105, of 24
p.(None): March 2005, and clinical and laboratory screening information from the Cell and Tissue Bank must be obtained
p.(None): Germinative (BCTG), as provided in Technical Regulation for the operation of BCTG.
p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
p.(None): donation, risks involved, laboratory tests, among others necessary for understanding and signing the informed consent form, which must be
p.(None): written in clear and comprehensible language for the layperson and should contain, when appropriate, the following items:
p.(None): I - information on the risks to the donor and benefits to the recipient of the donation;
p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
...

p.(None): its derivatives not collected by your team.
p.(None): § 2 The collection report must contain, at least, the following information:
p.(None): I- name of the patient donor;
p.(None): II- Clinical and laboratory data;
p.(None): III- date and time of collection;
p.(None): IV- responsible for the collection;
p.(None): V- description of the procedure;
p.(None): VI- storage temperature of biological material for transportation;
p.(None): VII- result of serological tests, if any; and
p.(None): VIII- Informed Consent Form.
p.(None): Section XII
p.(None): Processing and Storage
p.(None): Art. 48. All human biological material, being potentially infectious, must be handled in accordance with the
p.(None): biosafety requirements.
p.(None): Art. 49. All processing steps must be described in written and updated instructions, with protocols
p.(None): defined and validated, and must meet the specifications described in this Resolution.
p.(None): Art. 50. Processing protocols must prevent cross-contamination and material exchange.
p.(None): Art. 51. The simultaneous processing of human cells and their derivatives from more than one donor / patient in the
p.(None): same environment.
p.(None): Art. 52. The CTC must ensure cleanliness and asepsis in the processing room and its equipment at each processing.
p.(None): Art. 53. The handling and exposure of biological material and materials, reagents and products for in vitro diagnosis during
p.(None): processing must take place exclusively in an environment classified as ISO 5 (Class 100).
p.(None): Art. 54. For CTC 1, the environment classified as ISO 5 (Class 100) must be installed in a room with classification
p.(None): minimum ISO 8 (Class 100,000)
p.(None): Single paragraph. CTC 1 must have a barrier dressing room to access the room where the biological material will be processed,
p.(None): washbasin and dressing area.
p.(None): Art. 55. For CTC 2, the environment classified as ISO 5 (Class 100) must be installed in a room with classification
p.(None): minimum ISO 7 (Class 10,000).
p.(None): Sole paragraph: CTC 2, must have an ante-chamber and barrier dressing room equipped with a washbasin and a dressing area in the
p.(None): access to the room where biological material will be processed.
p.(None): Art. 56. All biological materials that are submitted to the process of cultivation, extensive manipulation or cryopreservation
p.(None): prior to their use in cell therapy, they must have a representative sample cryopreserved and stored in the same
p.(None): conditions, intended for use in process quality control tests.
p.(None): Single paragraph. The number of samples prepared must be sufficient to carry out quality control tests
p.(None): necessary to release the use of biological material, according to article 60 of this Resolution, and for future quality control, if
p.(None): complementary analyzes are needed.
p.(None): Art. 57. Storage must be carried out under controlled conditions that guarantee the maintenance of the characteristics
p.(None): cells.
p.(None): Art. 58. If the CTC has a system for storing cell units in liquid nitrogen tanks, or if there is a
p.(None): nitrogen safety system for a mechanical freezer with a temperature of minus 150 ° C or less, the
p.(None): cryopreservation and storage must have:
p.(None): I- external visualization of its interior;
p.(None): II-mechanical exhaustion system, for dilution of residual nitrogen traces, which promotes forced exhaustion of the entire
p.(None): air from the cryopreservation and storage room, with discharge to the building's external environment;
p.(None): III- environmental oxygen level sensor with audible and visual alarms, inside and outside the cryopreservation room and
p.(None): storage;
p.(None): IV- audible and visual alarms, internal and external to the cryopreservation and storage room, which alert to possible failures
p.(None): in the supply of liquid nitrogen and / or storage equipment; and
p.(None): V- thermometer for monitoring environmental temperature, indicating maximum and minimum values.
p.(None): § 1 The mechanical exhaust system must maintain a minimum total air flow of 75 (m3 / h) / m2.
p.(None): § 2 The replacement air must come from neighboring environments or be supplied by an insufflation of outside air, with filtration
p.(None): minimum with class G1 filter.
p.(None): § 3 The intake grilles of the mechanical exhaust system must be installed close to the floor.
p.(None): § 4 If a mechanical freezer with a temperature equal to or below 150 ° C is used, the cryopreservation room and
p.(None): storage must have an ambient temperature sensor with alarm.
p.(None): Art. 59. The units of cells and derivatives with positive microbiological tests or with a reagent result in at least one
p.(None): of markers for blood-borne infections should preferably be stored in a freezer or tank
p.(None): specific, separated from the other units with negative tests.
p.(None): Single paragraph. If the units of cells and derivatives with positive microbiological tests or with a reagent result in
p.(None): at least one of the markers for blood-borne diseases is packaged in the same equipment as
p.(None): units with non-reactive / negative results, an external packaging system or equipment
p.(None): ensure the protection of other cryopreserved units.
p.(None): Section XIII
p.(None): Quality Control of Cells
p.(None): Art. 60. Before releasing human cells and their derivatives for use in clinical research and / or therapy, whether for autologous use
p.(None): or allogeneic, cultivated or not, fresh or cryopreserved, with or without extensive handling, the CTC must guarantee its safety and
p.(None): quality.
p.(None): §1 The minimum requirements for ensuring the safety and quality of human cells and their derivatives are:
p.(None): I- microbiological tests;
p.(None): II- laboratory tests to detect infectious diseases in the donor / patient;
p.(None): III- pyrogenicity tests, when applicable;
p.(None): IV- cell count and viability;
p.(None): V- cell phenotyping, when applicable;
p.(None): VI-genetic control, which must be performed on cells subjected to culture and expansion or modified cells
p.(None): genetically and / or by protein transduction
p.(None): VII- functional test, when applicable; and
p.(None): VIII- identification of histocompatibility antigens (HLA), when applicable.
p.(None): § 2 If the results of microbiological and laboratory tests are not available before using the cells, this fact
p.(None): it must be justified and recorded.
p.(None): § 3 The results of the cell quality control tests must be attached to the patient's clinical record.
p.(None): donor / patient.
p.(None): Section XIV
p.(None): Release for use
p.(None): Art. 61. The packaging of human cells and their derivatives for clinical research and / or therapy, must be carried out in
p.(None): end-use packaging.
p.(None): Art. 62 The CTC must provide information on the conditions for receiving biological material, its use and occurrence
p.(None): unexpected or undesirable effects on the use of biological material.
p.(None): Single paragraph. Instructions for the use of cells and their derivatives must be provided to the professional responsible for their
p.(None): use at the time of release for use.
p.(None): Art. 63. The CTC technical officer must issue a certificate proving the qualification of human cells and their
p.(None): derivatives for use in clinical research and / or therapy containing at least the following items:
p.(None): I- identification of the CTC;
p.(None): II- address and telephone number of the CTC;
p.(None): III-identification of the technician responsible and his registration number with the respective regional professional council;
p.(None): IV- identification of the professional who released the exam and his registration number with the respective regional professional council;
p.(None): V- name and registration number of the donor or recipient identification generated by the CTC;
p.(None): VI- date of issue of the report;
p.(None): VII- identification of the procedure performed;
p.(None): VIII- proof of the qualification of the material according to article 60 of this Resolution; and
p.(None): IX- observations and pertinent information, when applicable.
p.(None): Section XV
p.(None): Production Data
p.(None): Art.64. The CTC must send to the General Blood Management, other tissues, cells and organs of Anvisa, by electronic means,
p.(None): annual production report, stating:
p.(None): I-total number of biological material received for processing;
p.(None): II-number of biological material processed for cryopreservation;
p.(None): III- total number of biological material released for use in cell therapy; and
p.(None): IV- number of biological material discarded and the reason for disposal.
p.(None): Section XVI
p.(None): Sanitary Aspects of Transport
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p.(None): packaging, material transfer, temporary storage, cleaning and maintenance of equipment and vehicles, must be
p.(None): standardized through written and updated instructions and must be validated and recorded.
p.(None): Art. 67. The transport of human cells and their derivatives must be accompanied by a document that contains, at least,
p.(None): The following information:
p.(None): I- name of the sending CTC and destination service, including addresses and telephone numbers;
p.(None): II- emergency telephone and contact, in case of any problem during the transportation route;
p.(None): III-quantity of human cells and their derivatives transported, in total number and fractioned quantity (packaged);
p.(None): IV- name of the recipient patient and the responsible physician;
p.(None): V-date and time of transport and name of the person responsible for transport; and
p.(None): VI- the material's validity time, kept in transport conditions (in the package sent and not violated).
p.(None): Art. 68 Human cells and their derivatives must be transported by a duly trained professional.
p.(None): §1 The responsibility for the material transported must be defined in a contract or similar instrument entered into between the
p.(None): CTC and the service that will receive you.
p.(None): §2 The transport of human cells and their derivatives implies responsibilities for the sender, the recipient and the company
p.(None): shipping company.
p.(None): Art. 69. The packaging, labeling and signs used in the transport of human cells and their derivatives must follow the
p.(None): specifications of the current legislation, in order to guarantee the stability and integrity of the material, as well as the safety of the
p.(None): people and the environment.
p.(None): Single paragraph. Packaging containing dry ice, liquid nitrogen, cryogenic liquid, non-flammable gas or other
p.(None): conservation and preservation material that presents risks during the transport process, must be sign posted
p.(None): in accordance with national and international standards for the transport of dangerous products.
p.(None): Art. 70. The transport of human cells and their derivatives, after collection or processing, must be carried out in a container
p.(None): resistant isothermal and with cover, which has an internal temperature monitoring and recording system.
p.(None): §1 The appropriate and accepted limits for maintaining temperature in the isothermal container must be established by the CTC.
p.(None): §2º It is expressly forbidden to subject the container to radiation, even at airports.
p.(None): §3º On the external side of the isothermal container, the following warning must appear: "HUMAN BIOLOGICAL MATERIAL. NO
p.(None): SUBMIT TO RADIATION (X-RAYS) "
p.(None): §4 In cases of international transport, the notice referred to in the previous paragraph must be written in English.
p.(None): Section XV
p.(None): Registry and Files
p.(None): Art. 71. The CTC must have a registration system that allows the traceability of human cells and their derivatives, since their
p.(None): until its final destination, including its laboratory analysis.
p.(None): Art. 72. All records referring to human cells and their derivatives, collection or receipt of biological material,
p.(None): processing and storage of biological material, raw data, copies of released reports and procedures related to the
p.(None): quality control and quality assurance performed by the CTC must be filed for a minimum period of 5 (five) years.
p.(None): §1º The medical records must be filed for a minimum period of 20 (twenty) years under the responsibility of the physician (or
...

p.(None): I- clinical screening data, when applicable;
p.(None): II- collection data;
p.(None): III- packing and transport data;
p.(None): IV- data of processing, storage and cryopreservation;
p.(None): V- results of laboratory screening;
p.(None): VI- results of tests performed to make cells available;
p.(None): VII-date and reason for the disposal of the samples, when applicable;
p.(None): VIII-Free and Informed Consent Form (ICF) signed by the donor or his legal guardian;
p.(None): IX-Free and Informed Consent Form (ICF) signed by the recipient, when applicable;
p.(None): X- request for human cells and their derivatives signed by the professional physician responsible for the procedure
p.(None): therapeutic; and
p.(None): XI-request for human cells and their derivatives for clinical research approved by the Ethics Committee (CEP), signed by
p.(None): responsible;
p.(None): Art. 74. The CTC must keep records of the services and / or professionals from which it receives biological material and for which it provides
p.(None): human cells and their derivatives.
p.(None): Section XVI
p.(None): Disposal of Biological Material
p.(None): Art. 75. CTC waste disposal must be in accordance with the Health Services Waste Management Plan
p.(None): (PGRSS) approved by the competent bodies and must be carried out in accordance with current regulations.
p.(None): CHAPTER IV
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 76. The establishments covered by this resolution will have a term of 1 (one) year from the date of its
p.(None): publication to promote the necessary adjustments to its fulfillment.
p.(None): Single paragraph. As of the publication of this Resolution, the new establishments and those that intend to restart their
p.(None): activities, must fully comply with the requirements contained therein, prior to its operation.
p.(None): Article 77. Failure to comply with the provisions contained in this Resolution constitutes a sanitary infraction, pursuant to Law No. 6,437, of
p.(None): August 20, 1977, without prejudice to the applicable civil, administrative and penal responsibilities.
p.(None): Art. 78. This Collegiate Board Resolution must be revised within a maximum period of 03 (three) years, from the date of its
p.(None): Publication.
p.(None): Art. 79. This resolution takes effect on the date of its publication.
p.(None): MARIA CECÍLIA MARTINS BRITO
p.(None): Deputy Chief Executive Officer
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p.(None): sterilization and storage, among others, and which do not lose their effectiveness and functionality after multiple uses;
p.(None): XXIX- Human biological material: body fluids, cells, tissues, excrement, organs or other fluids of human origin
p.(None): or isolated from these;
p.(None): XXX- own methodology performed in the laboratory (in house): reagents or analytical systems produced and validated by
p.(None): Cellular Technology Center itself, exclusively for own use, in clinical research or therapy;
p.(None): XXXI-clinical research: systematic study that follows scientific methods applicable to experiments with human cells
p.(None): and its derivatives in humans, in accordance with legal and ethical requirements;
p.(None): XXXII- health product: product that falls into at least one of the two categories described below:
p.(None): a) medical product - equipment, apparatus, material, article or system for medical or laboratory use or application, intended
p.(None): prevention, diagnosis, treatment, rehabilitation and that does not use pharmacological, immunological or metabolic means to
p.(None): perform its main function in human beings, being able, however, to be assisted in their functions by such means;
p.(None): b) product for diagnosis of in vitro use - reagents, standards, calibrators, controls, materials, articles and instruments,
p.(None): together with instructions for its use, which contribute to a qualitative, quantitative or semi-determination
p.(None): quantitative analysis of a sample from the human body and that are not intended to fulfill any anatomical function,
p.(None): physical or therapeutic, that are not ingested, injected or inoculated in humans and that are used only
p.(None): to provide information on samples obtained from the human organism;
p.(None): XXXIII- legally qualified professional: professional with higher education enrolled in the respective Board of Directors
p.(None): Class, with its powers attributed by Law;
p.(None): XXXIV- traceability: ability to retrieve the history, application or location of what is being
p.(None): considered, through registered identifications;
p.(None): XXXV- Technical Responsible (RT): legally qualified professional who assumes the technical responsibility of the CTC before
p.(None): health surveillance;
p.(None): XXXVI- room: an environment bounded by walls in all its perimeter and a door;
p.(None): XXXVII- therapy: any therapeutic process that uses human cells or their derivatives;
p.(None): XXXVIII- Informed Consent Form (ICF): consent form through which the research subject
p.(None): and / or their legal representative expressly agrees, authorizing their voluntary participation in the research, free from vices
p.(None): (simulation, fraud or error), dependence, subordination or intimidation, after a complete and detailed explanation of the
p.(None): nature of the research, its objectives, methods, expected benefits, potential risks and the discomfort it may cause;
p.(None): XXXIX- functional test: test that aims to verify and ensure the presence of functional and / or proliferative capacity of cells
p.(None): human beings and their derivatives;
p.(None): XL- microbiological test: test carried out according to current legislation, aiming at the detection of microbiological agents from
p.(None): a sample rate to be made available;
p.(None): XLI- pyrogenicity test: test that aims to check the presence of pyrogens in the sample of biological material;
p.(None): XLII- conventional hematopoietic progenitor cell transplantation: expression used to replace the expression
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p.(None): of the CTC.
p.(None): Section III
p.(None): From the Operational Technical Manual
p.(None): Art. 11. The CTC must have a Technical Operational Manual that defines in detail all the procedures for collection,
p.(None): processing, quality control, packaging, storage, release for use, transport and disposal of cells
p.(None): and their derivatives, in the form of written and updated instructions.
p.(None): Art. 12. The manual mentioned in the previous article must be accessible, at any time, to all employees and
p.(None): be present, in printed and electronic forms, in the respective sectors of the laboratory.
p.(None): Single paragraph. If the CTC uses the electronic form, there must be at least one printed copy available at the service.
p.(None): Art. 13. The manual must also:
p.(None): I - be reviewed annually and whenever there is any change;
p.(None): II- be signed and dated by the technical responsible of the CTC;
p.(None): III - indicate the professional responsible for each procedure;
p.(None): IV - contain the conducts in the face of non-conformities; and
p.(None): V - describe the biosafety rules to be followed by all employees.
p.(None): Section IV
p.(None): Administrative and Technical-Scientific Structure
p.(None): Art. 14. The CTC must have a professional team with training and qualification compatible with its activities.
p.(None): Art. 15. The CTC must keep training and qualification records of its professionals compatible with the functions available
p.(None): performed.
p.(None): Art. 16. The CTC should promote training and permanent education of its employees, keeping records of
p.(None): themselves.
p.(None): Art. 17. The technical responsibility must be the responsibility of a professional with a higher education degree, with a master's or doctorate in the area of
p.(None): health or biological sciences, and minimum experience of 5 (five) years in cellular and / or molecular biology and registered in the respective
p.(None): class council.
p.(None): §1º The CTC must have a substitute technical manager with the same professional qualification as the technical manager.
p.(None): §2º The time of master's and / or doctorate in the area of cellular and / or molecular biology may be counted as time of
p.(None): professional experience.
p.(None): Art. 18. The technician responsible may have, before the health surveillance, the responsibility for a maximum of 1 (one) CTC.
p.(None): Section V
p.(None): Quality Assurance
p.(None): Art. 19. The technical responsible of the CTC has the responsibility to plan, implement and guarantee the quality of the processes,
p.(None): which includes:
p.(None): I - the maintenance of the technical team and resources necessary for the performance of its duties;
p.(None): II - the protection of confidential sample information;
p.(None): III - the supervision of technical personnel by a professional with a higher education degree, legally qualified during their
p.(None): operation;
p.(None): IV - the qualification and verification of equipment, instruments and materials, reagents and products for diagnosis
p.(None): in vitro use used, before being put to use;
p.(None): V-the use of techniques as recommended by the manufacturer (equipment and products) or, when applicable, as
p.(None): validation performed by the CTC;
p.(None): VI - the adoption of procedures for the detection, registration, correction and prevention of errors and non-conformities, including
p.(None): carrying out internal quality control of the CTC; and
p.(None): VII - the implementation and maintenance of the traceability of all its processes.
p.(None): Art. 20. The CTC must have written and updated instructions for the technical routines implemented.
p.(None): Section VI
p.(None): Biosafety
p.(None): Art. 21. The CTC must keep updated and make available, to all employees, written instructions on biosafety,
p.(None): covering at least the following items:
p.(None): I - biological, chemical, physical, occupational and environmental safety standards and conducts;
p.(None): II -instructions for use for personal protective equipment (PPE) and collective protection equipment (EPC);
p.(None): III - procedures in case of accidents; and
p.(None): IV - handling of material transport and biological sample.
p.(None): Art. 22. The technical responsible for the CTC must document the level of biosafety of the environments and areas based on the
p.(None): procedures performed and equipment used, adopting compatible safety measures.
p.(None): Section VII
p.(None): Of Materials, Reagents and Products for Diagnosis of in vitro Use
p.(None): Art. 23. The materials, reagents and products for diagnosis of in vitro use used for collection, processing, tests
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p.(None): VIII- cell count: determination of the total number of nucleated cells by manual or automated system, validated
p.(None): and recorded in written and updated instructions;
p.(None): IX- somatic cells: differentiated adult cells;
p.(None): X- human stem cell: cell of human origin that has the ability to self-renew for long periods of time
p.(None): time and differentiate when receiving specific stimuli;
p.(None): XI- adult stem cells (CTA): stem cells originated from different organs and tissues, after the birth of the
p.(None): individual (post partum), including extra-embryonic attachments (placenta and umbilical cord);
p.(None): XII- embryonic stem cells (CTE): pre-implantation embryo cells that have the ability to transform
p.(None): in cells of any tissue of an organism;
p.(None): XIII- induced pluripotent stem cells (CTPi): cells created from reprogramming somatic cells, CTA or
p.(None): any other type of human cell;
p.(None): XIV- Cellular Technology Centers (CTC): a service that, with physical facilities, human resources, equipment, materials,
p.(None): reagents and products for in vitro diagnostic use and methodologies, performs activities aimed at the use of cells
p.(None): human beings, including their derivatives, in clinical research and / or therapy;
p.(None): XV - National Research Ethics Commission (CONEP / MS): collegiate and independent body, of an advisory nature,
p.(None): deliberative, normative, educational, linked to the National Health Council;
p.(None): XVI-Research Ethics Committees (CEP): interdisciplinary and independent collegiate bodies, with public munus, of character
p.(None): consultative, deliberative and educational, created to defend the interests of the research subjects in their integrity and
p.(None): dignity and to contribute to the development of research within ethical standards;
p.(None): XVII-genetic control: control that uses a method to identify numerical and / or structural chromosomal abnormalities
p.(None): human chromosomes, with adequate attention to the sample's statistical representativeness of the test;
p.(None): XVIII-cell culture: maintenance of cells in vitro in adequate environmental conditions in appropriate culture media;
p.(None): XIX- derivatives of human cells: cellular components, produced and secreted molecules and organic matrices
p.(None): mineralized or not;
p.(None): XX- Health Assistance Establishments (EAS): any building destined to provide health assistance to the
p.(None): population, whether in hospital or not, whatever their level of complexity;
p.(None): XXI- cell expansion (in vitro): cultivation of cells in ideal environmental conditions to obtain a cell mass
p.(None): sufficient for use in clinical research and / or therapy procedures;
p.(None): XXII-Cell Phenotyping: Percentage molecular identification, which indicates the homogeneity or heterogeneity of the samples
p.(None): of cells to be made available;
p.(None): XXIII- quality assurance: set of activities planned, systematized and implemented with the objective of fulfilling the
p.(None): specified quality requirements;
p.(None): XXIV-release for use: delivery of human cells and their derivatives, under conditions of safety and quality
p.(None): appropriate for clinical research and / or therapy, as provided for in article 60 of this Resolution, to the professional legally
p.(None): responsible for its use;
p.(None): XXV-fresh manipulation: manipulation of cells and / or derivatives, autologous or allogeneic, not subjected to expansion
p.(None): cell and cell culture;
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p.(None): characterized by different dimensions and facilities, which may consist of a room or an area;
p.(None): III- ante-chamber: area adjacent to the processing room that guarantees the exclusive access of people to it.
p.(None): IV-human application: use of tissues or cells, including their derivatives, as application, infusion, implant or
p.(None): transplantation into a human recipient;
p.(None): V-area: open environment, without walls on one or more of one of the faces;
p.(None): VI- Germ Cell and Tissue Bank (BCTG): health service designed to select, collect, transport, record,
p.(None): process, store, discard and release cells, germ tissues and embryos, for own use or donation;
p.(None): VII- biosafety: security condition achieved by a set of actions aimed at preventing, controlling, reducing or
p.(None): eliminate risks inherent in activities that may compromise human, animal health and the environment;
p.(None): VIII- cell count: determination of the total number of nucleated cells by manual or automated system, validated
p.(None): and recorded in written and updated instructions;
p.(None): IX- somatic cells: differentiated adult cells;
p.(None): X- human stem cell: cell of human origin that has the ability to self-renew for long periods of time
p.(None): time and differentiate when receiving specific stimuli;
p.(None): XI- adult stem cells (CTA): stem cells originated from different organs and tissues, after the birth of the
p.(None): individual (post partum), including extra-embryonic attachments (placenta and umbilical cord);
p.(None): XII- embryonic stem cells (CTE): pre-implantation embryo cells that have the ability to transform
p.(None): in cells of any tissue of an organism;
p.(None): XIII- induced pluripotent stem cells (CTPi): cells created from reprogramming somatic cells, CTA or
p.(None): any other type of human cell;
p.(None): XIV- Cellular Technology Centers (CTC): a service that, with physical facilities, human resources, equipment, materials,
p.(None): reagents and products for in vitro diagnostic use and methodologies, performs activities aimed at the use of cells
p.(None): human beings, including their derivatives, in clinical research and / or therapy;
p.(None): XV - National Research Ethics Commission (CONEP / MS): collegiate and independent body, of an advisory nature,
p.(None): deliberative, normative, educational, linked to the National Health Council;
p.(None): XVI-Research Ethics Committees (CEP): interdisciplinary and independent collegiate bodies, with public munus, of character
p.(None): consultative, deliberative and educational, created to defend the interests of the research subjects in their integrity and
p.(None): dignity and to contribute to the development of research within ethical standards;
p.(None): XVII-genetic control: control that uses a method to identify numerical and / or structural chromosomal abnormalities
p.(None): human chromosomes, with adequate attention to the sample's statistical representativeness of the test;
p.(None): XVIII-cell culture: maintenance of cells in vitro in adequate environmental conditions in appropriate culture media;
p.(None): XIX- derivatives of human cells: cellular components, produced and secreted molecules and organic matrices
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p.(None): allogeneic, fresh or cryopreserved, with or without cultivation, with or without extensive manipulation for use in clinical research
p.(None): and / or therapy
p.(None): §1º CTC type 1 is only able to process or cryopreserve human cells and their derivatives collected for use in
p.(None): clinical research and / or therapy that are known not to require further expansion, only need minimal manipulation and
p.(None): which are undoubtedly for autologous use.
p.(None): §2º The activities carried out by CTC type 1 are:
p.(None): I - collect or guide the collection of biological material;
p.(None): II - cryopreserve and store adult human cells and their derivatives;
p.(None): III - receive and, when necessary, provide clinical and laboratory screening of the patient;
p.(None): IV - evaluate the quality of the biological material received or collected;
p.(None): V - process the biological material;
p.(None): VI - carry out or provide the necessary tests to release the material in accordance with article 60 of this Resolution;
p.(None): VII-provide adult human cells and their derivatives for clinical research and / or therapy, providing the information
p.(None): needed;
p.(None): VIII-provide written guidance on the handling, conditioning and validity of adult human cells and their
p.(None): derivatives made available for use in clinical research and / or therapy;
p.(None): IX- carry out or provide transportation in order to guarantee the integrity of the biological material; and
p.(None): X- keep a record that allows the traceability of adult human cells and their derivatives, from collection to use.
p.(None): §3 In addition to the activities mentioned in the previous paragraph for type 1 CTC, type 2 CTC may also:
p.(None): I - maintain culture in order to expand or differentiate adult human cells;
p.(None): II - perform human embryo culture extension to the blastocyst stage;
p.(None): III - transport embryos and human embryonic stem cells;
p.(None): IV - receiving and storing embryos that were made available for clinical research and therapy;
p.(None): V - perform the induction for differentiation of embryonic stem cells;
p.(None): VI - perform the reprogramming of human cells to induced pluripotent cells (CTPi);
p.(None): VII- cryopreserve, store, manipulate and process embryonic human stem cells and CTPi;
p.(None): VIII- provide human cells and their derivatives for clinical research and / or therapy providing the necessary information,
p.(None): respecting the confidentiality of the donation; and
p.(None): IX-provide written guidance regarding the handling, packaging and validity of cells and their derivatives
p.(None): available for use in clinical research and / or therapy.
p.(None): Section II
p.(None): Internal Regulations
p.(None): Art. 10. The CTC must have an internal regulation that contains the following items:
p.(None): I - purpose;
p.(None): II - organization chart, describing the administrative and technical-scientific structure of the CTC, with definition of the legal responsible and the
p.(None): technical responsible (the functions of legal responsible and technical responsible can be exercised by the same professional);
p.(None): and
p.(None): III - nominal list, accompanied by the corresponding signature of all administrative and technical-scientific personnel,
p.(None): indicating the qualification, functions and responsibilities of the technical manager and other CTC professionals.
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p.(None): VIII- provide human cells and their derivatives for clinical research and / or therapy providing the necessary information,
p.(None): respecting the confidentiality of the donation; and
p.(None): IX-provide written guidance regarding the handling, packaging and validity of cells and their derivatives
p.(None): available for use in clinical research and / or therapy.
p.(None): Section II
p.(None): Internal Regulations
p.(None): Art. 10. The CTC must have an internal regulation that contains the following items:
p.(None): I - purpose;
p.(None): II - organization chart, describing the administrative and technical-scientific structure of the CTC, with definition of the legal responsible and the
p.(None): technical responsible (the functions of legal responsible and technical responsible can be exercised by the same professional);
p.(None): and
p.(None): III - nominal list, accompanied by the corresponding signature of all administrative and technical-scientific personnel,
p.(None): indicating the qualification, functions and responsibilities of the technical manager and other CTC professionals.
p.(None): Single paragraph. The maintenance and updating of the list provided for in item III of the caput are the responsibility of the technical responsible
p.(None): of the CTC.
p.(None): Section III
p.(None): From the Operational Technical Manual
p.(None): Art. 11. The CTC must have a Technical Operational Manual that defines in detail all the procedures for collection,
p.(None): processing, quality control, packaging, storage, release for use, transport and disposal of cells
p.(None): and their derivatives, in the form of written and updated instructions.
p.(None): Art. 12. The manual mentioned in the previous article must be accessible, at any time, to all employees and
p.(None): be present, in printed and electronic forms, in the respective sectors of the laboratory.
p.(None): Single paragraph. If the CTC uses the electronic form, there must be at least one printed copy available at the service.
p.(None): Art. 13. The manual must also:
p.(None): I - be reviewed annually and whenever there is any change;
p.(None): II- be signed and dated by the technical responsible of the CTC;
p.(None): III - indicate the professional responsible for each procedure;
p.(None): IV - contain the conducts in the face of non-conformities; and
p.(None): V - describe the biosafety rules to be followed by all employees.
p.(None): Section IV
p.(None): Administrative and Technical-Scientific Structure
p.(None): Art. 14. The CTC must have a professional team with training and qualification compatible with its activities.
p.(None): Art. 15. The CTC must keep training and qualification records of its professionals compatible with the functions available
p.(None): performed.
p.(None): Art. 16. The CTC should promote training and permanent education of its employees, keeping records of
p.(None): themselves.
p.(None): Art. 17. The technical responsibility must be the responsibility of a professional with a higher education degree, with a master's or doctorate in the area of
p.(None): health or biological sciences, and minimum experience of 5 (five) years in cellular and / or molecular biology and registered in the respective
p.(None): class council.
p.(None): §1º The CTC must have a substitute technical manager with the same professional qualification as the technical manager.
p.(None): §2º The time of master's and / or doctorate in the area of cellular and / or molecular biology may be counted as time of
p.(None): professional experience.
p.(None): Art. 18. The technician responsible may have, before the health surveillance, the responsibility for a maximum of 1 (one) CTC.
p.(None): Section V
p.(None): Quality Assurance
p.(None): Art. 19. The technical responsible of the CTC has the responsibility to plan, implement and guarantee the quality of the processes,
p.(None): which includes:
p.(None): I - the maintenance of the technical team and resources necessary for the performance of its duties;
p.(None): II - the protection of confidential sample information;
p.(None): III - the supervision of technical personnel by a professional with a higher education degree, legally qualified during their
p.(None): operation;
p.(None): IV - the qualification and verification of equipment, instruments and materials, reagents and products for diagnosis
p.(None): in vitro use used, before being put to use;
p.(None): V-the use of techniques as recommended by the manufacturer (equipment and products) or, when applicable, as
p.(None): validation performed by the CTC;
p.(None): VI - the adoption of procedures for the detection, registration, correction and prevention of errors and non-conformities, including
p.(None): carrying out internal quality control of the CTC; and
p.(None): VII - the implementation and maintenance of the traceability of all its processes.
p.(None): Art. 20. The CTC must have written and updated instructions for the technical routines implemented.
p.(None): Section VI
p.(None): Biosafety
p.(None): Art. 21. The CTC must keep updated and make available, to all employees, written instructions on biosafety,
p.(None): covering at least the following items:
p.(None): I - biological, chemical, physical, occupational and environmental safety standards and conducts;
p.(None): II -instructions for use for personal protective equipment (PPE) and collective protection equipment (EPC);
p.(None): III - procedures in case of accidents; and
p.(None): IV - handling of material transport and biological sample.
p.(None): Art. 22. The technical responsible for the CTC must document the level of biosafety of the environments and areas based on the
p.(None): procedures performed and equipment used, adopting compatible safety measures.
p.(None): Section VII
p.(None): Of Materials, Reagents and Products for Diagnosis of in vitro Use
p.(None): Art. 23. The materials, reagents and products for diagnosis of in vitro use used for collection, processing, tests
p.(None): laboratories, preservation and expansion of human stem cells and their derivatives must be regularized with Anvisa, in accordance
p.(None): according to the specific legislation in force.
p.(None): Art. 24. All materials, reagents and products for in vitro diagnosis used and which maintain contact with cells and
p.(None): their derivatives, must be sterile, pyrogenic, non-cytotoxic and, when applicable, for single use, as well as
p.(None): registered lot number and validity to ensure traceability.
p.(None): Single paragraph. For materials subject to processing there must be a cleaning and sterilization procedure
p.(None): validated in accordance with current legislation.
p.(None): Art. 25. Reagents prepared or aliquoted by the laboratory itself must be identified with a label containing: name,
p.(None): concentration, batch number (if applicable), date of preparation, identification of who prepared it (when applicable), expiration date,
p.(None): storage conditions, as well as information regarding potential risks.
p.(None): Single paragraph. Records of the preparation processes and quality control of the prepared reagents must be kept.
p.(None): Art. 26. The use of materials, reagents and products for diagnosis of in vitro use must respect the recommendations for use
p.(None): manufacturer, preservation conditions, storage and expiration dates, and their revalidation is not allowed after
p.(None): expiry.
p.(None): Art. 27. The CTC that uses its own methodologies - in house, must document them including at least:
p.(None): I - description of the stages of the process;
p.(None): II - the specification and approval system for materials, reagents and products for in vitro diagnostics, equipment
p.(None): and instruments;
p.(None): III - the validation system; and
p.(None): IV - the registration of the entire process.
p.(None): Art. 28. The use of products of animal origin must be avoided.
p.(None): §1º If products of animal origin are used, they must have a certificate of absence of infectious agents and
p.(None): contaminants.
p.(None): §2 For growth factors, measures of identity, purity and potency must be established to ensure
p.(None): reproducibility of cell culture characteristics.
p.(None): Section VIII
p.(None): Equipment
p.(None): Art. 29. The CTC must comply with the following requirements regarding equipment:
p.(None): I - have specific equipment and instruments and in the quantity necessary to meet your demand;
p.(None): II - maintain written and updated instructions regarding the use of the equipment available to sector employees, the
p.(None): which must be complemented by the manufacturer's manuals in Portuguese;
p.(None): III - maintain and implement a preventive and corrective maintenance program, containing an intervention schedule;
p.(None): IV - maintain the calibrated measuring equipment and the respective records; and
p.(None): V - keep records of the origin and series of the equipment used in order to guarantee traceability.
p.(None): Single paragraph. In the event described in item III of this article, all interventions performed on the equipment must be
p.(None): registered systematically, informing day, responsible for the intervention, description of the intervention and, in case of replacement of
p.(None): parts, list of replaced parts.
p.(None): Art. 30. The equipment and instruments used, national and imported, must be regularized with Anvisa, in accordance with
p.(None): current legislation.
p.(None): Art. 31. The spreadsheets to control the equipment's use and maintenance routines must be permanently available
p.(None): for consult.
p.(None): Art. 32. A daily record of the condition of equipment, refrigerators, freezers or storage tanks must be maintained.
p.(None): storage, documenting temperature, CO2 level (for incubator) and nitrogen level.
p.(None): § 1 The verification and recording of temperature and CO2 level, when applicable, must be carried out at defined intervals
p.(None): by the CTC for equipment that does not have an automatic recorder.
p.(None): § 2 The records must be signed and periodically reviewed by a qualified person.
p.(None): § 3 The alarms must be tested.
p.(None): §4º There must be a written procedure, defining the conduct to be taken in relation to the storage of samples if
p.(None): there is a defect in the storage equipment.
...

Searching for indicator parents:

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p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
p.(None): donation, risks involved, laboratory tests, among others necessary for understanding and signing the informed consent form, which must be
p.(None): written in clear and comprehensible language for the layperson and should contain, when appropriate, the following items:
p.(None): I - information on the risks to the donor and benefits to the recipient of the donation;
p.(None): II - information about the tests that will be carried out to qualify the donor;
p.(None): III -authorization to access the donor's clinical data and medical history to obtain clinical data with
p.(None): potential importance for the clinical research and / or therapy procedure;
p.(None): IV - authorization for the CTC to transfer qualitative and quantitative data on the material to the person responsible for the research
p.(None): clinic and / or therapy;
p.(None): V - authorization to store samples of cells, plasma, serum and donor DNA for tests that are necessary
p.(None): in the future;
p.(None): VI - authorization to dispose of units that do not meet the criteria for storage or later use in
p.(None): clinical research and / or therapy.
p.(None): § 1 At any time during the process, the donor has the right to withdraw from the donation.
p.(None): § 2 In the case of a donor under the age of 18 or mentally disabled, the IC must be confirmed by the parents or
p.(None): legal responsible.
p.(None): Art. 41. The use of human cells and their derivatives for donation that does not fully meet the qualification criteria
p.(None): will depend on joint assessment and decision between the person responsible for clinical research and / or therapy, the medical team of the service where
p.(None): the cells and their derivatives, the donor and the recipient or their legal guardians will be applied.
p.(None): Art. 42. Exclusion criteria for the candidate to donate human cells for allogeneic use are:
p.(None): I- infection confirmed by the HIV-1/2 virus;
p.(None): II- non-reactive HBsAg test with anti-HBc reagent, except when the donor is anti-HBs reagent;
p.(None): III- HBsAg reagent test, except when the recipient is also HBsAg reagent;
p.(None): IV- anti-HCV reagent test, except when the recipient also presents a reagent test in the qualitative research of RNA-
p.(None): HCV;
p.(None): V- malignant neoplastic disease, except basal cell carcinoma of the skin and carcinoma "in situ" of the cervix;
p.(None): VI-irreversible clinical condition that puts the donor's health at risk;
p.(None): VII- ongoing pregnancy;
p.(None): VIII-reversible clinical condition that puts the donor's health at risk; as the criteria for temporary disqualification
p.(None): blood donation, according to specific legislation in force.
p.(None): § 1 Definitive criteria for the exclusion of donors of human cells and their derivatives for allogeneic use are considered
p.(None): conditions provided for in items I to VI of the "caput" of this article.
p.(None): § 2 Temporary exclusion criteria for donors of human cells and their derivatives for allogeneic use are considered
...

General/Other / Manipulable

Searching for indicator manipulate:

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p.(None): II - cryopreserve and store adult human cells and their derivatives;
p.(None): III - receive and, when necessary, provide clinical and laboratory screening of the patient;
p.(None): IV - evaluate the quality of the biological material received or collected;
p.(None): V - process the biological material;
p.(None): VI - carry out or provide the necessary tests to release the material in accordance with article 60 of this Resolution;
p.(None): VII-provide adult human cells and their derivatives for clinical research and / or therapy, providing the information
p.(None): needed;
p.(None): VIII-provide written guidance on the handling, conditioning and validity of adult human cells and their
p.(None): derivatives made available for use in clinical research and / or therapy;
p.(None): IX- carry out or provide transportation in order to guarantee the integrity of the biological material; and
p.(None): X- keep a record that allows the traceability of adult human cells and their derivatives, from collection to use.
p.(None): §3 In addition to the activities mentioned in the previous paragraph for type 1 CTC, type 2 CTC may also:
p.(None): I - maintain culture in order to expand or differentiate adult human cells;
p.(None): II - perform human embryo culture extension to the blastocyst stage;
p.(None): III - transport embryos and human embryonic stem cells;
p.(None): IV - receiving and storing embryos that were made available for clinical research and therapy;
p.(None): V - perform the induction for differentiation of embryonic stem cells;
p.(None): VI - perform the reprogramming of human cells to induced pluripotent cells (CTPi);
p.(None): VII- cryopreserve, store, manipulate and process embryonic human stem cells and CTPi;
p.(None): VIII- provide human cells and their derivatives for clinical research and / or therapy providing the necessary information,
p.(None): respecting the confidentiality of the donation; and
p.(None): IX-provide written guidance regarding the handling, packaging and validity of cells and their derivatives
p.(None): available for use in clinical research and / or therapy.
p.(None): Section II
p.(None): Internal Regulations
p.(None): Art. 10. The CTC must have an internal regulation that contains the following items:
p.(None): I - purpose;
p.(None): II - organization chart, describing the administrative and technical-scientific structure of the CTC, with definition of the legal responsible and the
p.(None): technical responsible (the functions of legal responsible and technical responsible can be exercised by the same professional);
p.(None): and
p.(None): III - nominal list, accompanied by the corresponding signature of all administrative and technical-scientific personnel,
p.(None): indicating the qualification, functions and responsibilities of the technical manager and other CTC professionals.
p.(None): Single paragraph. The maintenance and updating of the list provided for in item III of the caput are the responsibility of the technical responsible
p.(None): of the CTC.
p.(None): Section III
p.(None): From the Operational Technical Manual
p.(None): Art. 11. The CTC must have a Technical Operational Manual that defines in detail all the procedures for collection,
p.(None): processing, quality control, packaging, storage, release for use, transport and disposal of cells
p.(None): and their derivatives, in the form of written and updated instructions.
...

General/Other / Public Emergency

Searching for indicator emergency:

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p.(None): parts, list of replaced parts.
p.(None): Art. 30. The equipment and instruments used, national and imported, must be regularized with Anvisa, in accordance with
p.(None): current legislation.
p.(None): Art. 31. The spreadsheets to control the equipment's use and maintenance routines must be permanently available
p.(None): for consult.
p.(None): Art. 32. A daily record of the condition of equipment, refrigerators, freezers or storage tanks must be maintained.
p.(None): storage, documenting temperature, CO2 level (for incubator) and nitrogen level.
p.(None): § 1 The verification and recording of temperature and CO2 level, when applicable, must be carried out at defined intervals
p.(None): by the CTC for equipment that does not have an automatic recorder.
p.(None): § 2 The records must be signed and periodically reviewed by a qualified person.
p.(None): § 3 The alarms must be tested.
p.(None): §4º There must be a written procedure, defining the conduct to be taken in relation to the storage of samples if
p.(None): there is a defect in the storage equipment.
p.(None): § 5 The volume of liquid nitrogen in the reservoirs must be controlled and recorded at the frequency defined by the CTC.
p.(None): Section IX
p.(None): Minimum physical infrastructure
p.(None): Art. 33. The physical infrastructure of the CTC must, as appropriate, comply with the provisions of the technical regulation for planning,
p.(None): programming, elaboration and evaluation of physical projects of health care establishments, approved by RDC Anvisa nº
p.(None): 50, of February 21, 2002, or whatever replaces it, as well as the specific requirements contained in this Resolution and others
p.(None): current rules.
p.(None): Single paragraph. The CTC must have an emergency electricity system, as provided for in RDC Anvisa nº 50, of 21
p.(None): February 2002, or the one that replaces it, and must also observe the equipment manufacturer's instructions regarding
p.(None): requirements for using UPSs.
p.(None): Art. 34. The physical infrastructure of the CTC must be of exclusive use and access for such purpose, and must consist of
p.(None): environments in a layout that allows circulation with an independent flow of inputs, biological material, professionals and waste,
p.(None): allowing cleaning and maintenance, with the purpose of guaranteeing the quality of human cells and their derivatives in all
p.(None): stages of the process.
p.(None): Art. 35. The construction, renovation or adaptation in the physical structure of the CTC must be preceded by the approval of the project with the
p.(None): local health authority.
p.(None): Art. 36. The CTC must carry out microbiological control of its environments, equipment (CO2 incubator) and culture media,
p.(None): when it fits.
p.(None): § 1 In case there is manipulation of the culture media (aliquot, addition of components) previously registered or
p.(None): registered by Anvisa, their microbiological control must be performed.
p.(None): § 2 The microbiological control of the environments and the CO2 incubator must be carried out at defined time intervals
p.(None): by CTC, depending on the workflow.
p.(None): Section X
p.(None): Donor and / or patient selection
p.(None): Art. 37. The donation of human cells for use in clinical research or therapy must respect the legal and ethical precepts on the
p.(None): subject, ensuring confidentiality, non-perception of remuneration or direct benefit, and the Free and
...

p.(None): V- name and registration number of the donor or recipient identification generated by the CTC;
p.(None): VI- date of issue of the report;
p.(None): VII- identification of the procedure performed;
p.(None): VIII- proof of the qualification of the material according to article 60 of this Resolution; and
p.(None): IX- observations and pertinent information, when applicable.
p.(None): Section XV
p.(None): Production Data
p.(None): Art.64. The CTC must send to the General Blood Management, other tissues, cells and organs of Anvisa, by electronic means,
p.(None): annual production report, stating:
p.(None): I-total number of biological material received for processing;
p.(None): II-number of biological material processed for cryopreservation;
p.(None): III- total number of biological material released for use in cell therapy; and
p.(None): IV- number of biological material discarded and the reason for disposal.
p.(None): Section XVI
p.(None): Sanitary Aspects of Transport
p.(None): Art. 65. The transport of human cells and their derivatives must comply with current legislation, biosafety rules and
p.(None): technical requirements related to its conservation.
p.(None): Art. 66. All operations of the transportation process, including, among other stages, the conditions of packaging,
p.(None): packaging, material transfer, temporary storage, cleaning and maintenance of equipment and vehicles, must be
p.(None): standardized through written and updated instructions and must be validated and recorded.
p.(None): Art. 67. The transport of human cells and their derivatives must be accompanied by a document that contains, at least,
p.(None): The following information:
p.(None): I- name of the sending CTC and destination service, including addresses and telephone numbers;
p.(None): II- emergency telephone and contact, in case of any problem during the transportation route;
p.(None): III-quantity of human cells and their derivatives transported, in total number and fractioned quantity (packaged);
p.(None): IV- name of the recipient patient and the responsible physician;
p.(None): V-date and time of transport and name of the person responsible for transport; and
p.(None): VI- the material's validity time, kept in transport conditions (in the package sent and not violated).
p.(None): Art. 68 Human cells and their derivatives must be transported by a duly trained professional.
p.(None): §1 The responsibility for the material transported must be defined in a contract or similar instrument entered into between the
p.(None): CTC and the service that will receive you.
p.(None): §2 The transport of human cells and their derivatives implies responsibilities for the sender, the recipient and the company
p.(None): shipping company.
p.(None): Art. 69. The packaging, labeling and signs used in the transport of human cells and their derivatives must follow the
p.(None): specifications of the current legislation, in order to guarantee the stability and integrity of the material, as well as the safety of the
p.(None): people and the environment.
p.(None): Single paragraph. Packaging containing dry ice, liquid nitrogen, cryogenic liquid, non-flammable gas or other
p.(None): conservation and preservation material that presents risks during the transport process, must be sign posted
p.(None): in accordance with national and international standards for the transport of dangerous products.
p.(None): Art. 70. The transport of human cells and their derivatives, after collection or processing, must be carried out in a container
p.(None): resistant isothermal and with cover, which has an internal temperature monitoring and recording system.
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None): §4º There must be a written procedure, defining the conduct to be taken in relation to the storage of samples if
p.(None): there is a defect in the storage equipment.
p.(None): § 5 The volume of liquid nitrogen in the reservoirs must be controlled and recorded at the frequency defined by the CTC.
p.(None): Section IX
p.(None): Minimum physical infrastructure
p.(None): Art. 33. The physical infrastructure of the CTC must, as appropriate, comply with the provisions of the technical regulation for planning,
p.(None): programming, elaboration and evaluation of physical projects of health care establishments, approved by RDC Anvisa nº
p.(None): 50, of February 21, 2002, or whatever replaces it, as well as the specific requirements contained in this Resolution and others
p.(None): current rules.
p.(None): Single paragraph. The CTC must have an emergency electricity system, as provided for in RDC Anvisa nº 50, of 21
p.(None): February 2002, or the one that replaces it, and must also observe the equipment manufacturer's instructions regarding
p.(None): requirements for using UPSs.
p.(None): Art. 34. The physical infrastructure of the CTC must be of exclusive use and access for such purpose, and must consist of
p.(None): environments in a layout that allows circulation with an independent flow of inputs, biological material, professionals and waste,
p.(None): allowing cleaning and maintenance, with the purpose of guaranteeing the quality of human cells and their derivatives in all
p.(None): stages of the process.
p.(None): Art. 35. The construction, renovation or adaptation in the physical structure of the CTC must be preceded by the approval of the project with the
p.(None): local health authority.
p.(None): Art. 36. The CTC must carry out microbiological control of its environments, equipment (CO2 incubator) and culture media,
p.(None): when it fits.
p.(None): § 1 In case there is manipulation of the culture media (aliquot, addition of components) previously registered or
p.(None): registered by Anvisa, their microbiological control must be performed.
p.(None): § 2 The microbiological control of the environments and the CO2 incubator must be carried out at defined time intervals
p.(None): by CTC, depending on the workflow.
p.(None): Section X
p.(None): Donor and / or patient selection
p.(None): Art. 37. The donation of human cells for use in clinical research or therapy must respect the legal and ethical precepts on the
p.(None): subject, ensuring confidentiality, non-perception of remuneration or direct benefit, and the Free and
p.(None): Informed Consent Form (TCLE), according to current legislation.
p.(None): Art. 38. To obtain human cells, whether for autologous or for allogeneic use, the CTC must perform clinical and
p.(None): laboratory.
p.(None): Single paragraph. Laboratory screening should follow that determined for blood donation, according to current legislation.
p.(None): Art. 39. To obtain embryos or embryonic stem cells, the criteria of Law No. 11,105, of 24
p.(None): March 2005, and clinical and laboratory screening information from the Cell and Tissue Bank must be obtained
p.(None): Germinative (BCTG), as provided in Technical Regulation for the operation of BCTG.
p.(None): Art. 40. The service responsible for the selection of the donor and / or patient must provide all information related to the
...

Orphaned Trigger Words

p.(None): Art. 70. The transport of human cells and their derivatives, after collection or processing, must be carried out in a container
p.(None): resistant isothermal and with cover, which has an internal temperature monitoring and recording system.
p.(None): §1 The appropriate and accepted limits for maintaining temperature in the isothermal container must be established by the CTC.
p.(None): §2º It is expressly forbidden to subject the container to radiation, even at airports.
p.(None): §3º On the external side of the isothermal container, the following warning must appear: "HUMAN BIOLOGICAL MATERIAL. NO
p.(None): SUBMIT TO RADIATION (X-RAYS) "
p.(None): §4 In cases of international transport, the notice referred to in the previous paragraph must be written in English.
p.(None): Section XV
p.(None): Registry and Files
p.(None): Art. 71. The CTC must have a registration system that allows the traceability of human cells and their derivatives, since their
p.(None): until its final destination, including its laboratory analysis.
p.(None): Art. 72. All records referring to human cells and their derivatives, collection or receipt of biological material,
p.(None): processing and storage of biological material, raw data, copies of released reports and procedures related to the
p.(None): quality control and quality assurance performed by the CTC must be filed for a minimum period of 5 (five) years.
p.(None): §1º The medical records must be filed for a minimum period of 20 (twenty) years under the responsibility of the physician (or
p.(None): institution) responsible for the patient receiving human cells and / or their derivatives.
p.(None): §2º These records can be made in electronic, printed or micro-film in such a way that they are easily
p.(None): recoverable and guarantee their traceability.
p.(None): §3 In the case of using electronic means, data must be stored in backup copies with protection against fraud
p.(None): or data changes and guarantee of inviolability.
p.(None): §4º All CTC records must be confidential.
p.(None): Art. 73. The CTC must maintain files of documents and records relating, at least, to:
p.(None): I- clinical screening data, when applicable;
p.(None): II- collection data;
p.(None): III- packing and transport data;
p.(None): IV- data of processing, storage and cryopreservation;
p.(None): V- results of laboratory screening;
p.(None): VI- results of tests performed to make cells available;
p.(None): VII-date and reason for the disposal of the samples, when applicable;
p.(None): VIII-Free and Informed Consent Form (ICF) signed by the donor or his legal guardian;
p.(None): IX-Free and Informed Consent Form (ICF) signed by the recipient, when applicable;
p.(None): X- request for human cells and their derivatives signed by the professional physician responsible for the procedure
p.(None): therapeutic; and
p.(None): XI-request for human cells and their derivatives for clinical research approved by the Ethics Committee (CEP), signed by
p.(None): responsible;
p.(None): Art. 74. The CTC must keep records of the services and / or professionals from which it receives biological material and for which it provides
p.(None): human cells and their derivatives.
p.(None): Section XVI
p.(None): Disposal of Biological Material
p.(None): Art. 75. CTC waste disposal must be in accordance with the Health Services Waste Management Plan
p.(None): (PGRSS) approved by the competent bodies and must be carried out in accordance with current regulations.
p.(None): CHAPTER IV
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS ...

Appendix

Indicator List

Indicator	Vulnerability
HIV	HIV/AIDS
access	Access to Social Goods
age	Age
authority	Relationship to Authority
dependence	Drug Dependence
disabled	Mentally Disabled
education	education
educational	education
embryo	embryo
emergency	Public Emergency
employees	employees
language	Linguistic Proficiency
manipulate	Manipulable
mentally	Mentally Disabled
officer	Police Officer
parents	parents
physically	Physically Disabled
single	Marital Status
stem cells	stem cells

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
disabled	['mentally']
education	['educational']
educational	['education']
mentally	['disabled']

Trigger Words

capacity

consent

ethics

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Dependence	dependence	1
Health	HIV/AIDS	HIV	1
Health	Mentally Disabled	disabled	1
Health	Mentally Disabled	mentally	1
Health	Physically Disabled	physically	1
Health	stem cells	stem cells	14
Social	Access to Social Goods	access	6
Social	Age	age	1
Social	Linguistic Proficiency	language	1
Social	Marital Status	single	18
Social	Police Officer	officer	3
Social	education	education	4
Social	education	educational	2
Social	embryo	embryo	2
Social	employees	employees	5
Social	parents	parents	1
General/Other	Manipulable	manipulate	1
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	1

Resolution RDC No. 9, 14 March 2011

Applicable Type / Vulnerability / Indicator Overlay for this Input

Health / Drug Dependence

Health / HIV/AIDS

Health / Mentally Disabled

Health / Physically Disabled

Health / stem cells

Social / Access to Social Goods

Social / Age

Social / Linguistic Proficiency

Social / Marital Status

Social / Police Officer

Social / education

Social / embryo

Social / employees

Social / parents

General/Other / Manipulable

General/Other / Public Emergency

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input