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Federal law consolidated: Entire legal provision for tissue banking regulation, version dated February 19, 2020 Print view
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Ordinance of the Federal Minister for Health, Family and Youth, with which more detailed regulations for the operation of tissue banks are made
(Tissue Bank Ordinance - GBVO)
StF: BGBl. II No. 192/2008 [CELEX-No .: 32006L0017, 32006L0086]
modification
BGBl. II No. 87/2014 [CELEX-No .: 32012L0039]
BGBl. II No. 18/2017 [CELEX-No .: 32015L0565]
Preamble / Promulgatory
On the basis of Section 30 of the Tissue Safety Act, Federal Law Gazette I No. 49/2008, the following is prescribed:
text
scope
Section 1. (1) This Ordinance applies to the operation of tissue banks in accordance with Section 2 (15) of the Tissue Security Act (GSG), Federal Law Gazette I No. 49/2008.
(2) The General Employee Protection Ordinance, BGBl. № 218/1983, last amended by the Ordinance BGBl. II № 77/2007, and the Ordinance
biological agents, Federal Law Gazette II No. 237/1998, are not affected by this regulation.
(3) The initial provisions of Section 2 of the Tissue Safety Act (GSG), Federal Law Gazette I No. 49/2008, and Section 1 of the Tissue Removal Equipment Ordinance,
BGBl. II No. 191/2008, each in the current version, also apply to this regulation.
quality system
§ 2. (1) The quality management of tissue banks includes all coordinated activities related to the management and control of a tissue bank
Quality at all levels.
(2) Quality is to be striven for by everyone involved in the work processes of the tissue bank, with the management and the responsible
Ensure a systematic quality standard and the introduction and maintenance of a quality system according to § 9 GSG
(3) The function of the quality management system must be checked regularly to enable continuous and systematic improvements.
(4) All written instructions, procedural instructions, speci fi cations, manufacturing instructions, standard operating instructions (SOPs) and others
Relevant documents in connection with the receipt, processing, testing, storage and distribution of cells and tissues are from the
approve the responsible person by signature.
staff
§ 3. (1) Tissue banks must have sufficient qualified personnel to carry out the activities for which they have been authorized.
(2) The staff must be trained before starting work and when procedures or new scientific knowledge change
receive sufficient opportunities for appropriate professional development. The training programs must ensure that all employees are involved
have performed the tasks assigned to them as knowledgeable, have sufficient knowledge and understanding of the
scientific / technical procedures and principles that are relevant to the tasks assigned to them, the organizational framework that
Understand the quality system as well as the health and safety regulations of the institution in which they work and are sufficiently aware of the other ethical ones
and the legal context of their work. Records must be kept of the training measures, in which in particular the date, duration,
Place and content as well as all lecturers and participants are listed. The implementation of each training event is by the signature of the
To confirm the lecturer and the participants. The specialist knowledge of the staff is to be assessed regularly as part of the quality system.
(3) The tasks and areas of responsibility are to be defined in an organizational chart.
(4) The tasks and responsibilities of the staff in tissue banks must be set out in job descriptions that are added regularly
are updating.
(5) The functional descriptions and organizational diagrams must be approved in accordance with internal company procedures.
(6) The responsible person is in addition to the tasks according to § 11 and the tasks within the framework of the tissue vigilance regulation, BGBl. II No. 190/2008
responsible for ensuring that the tissue bank fulfills its obligations in accordance with paragraphs 1 and 2 within the framework of the documentation, quality assurance, and acceptance,
Processing, storage, labeling, packaging and distribution of cells and tissues, as well as in connection with relationships with third parties.
(7) The responsible person and all employees in a managerial or responsible position are to be granted sufficient powers to ensure that they have their
Can perform tasks.
premises
§ 4. (1) The premises are to be set up and maintained in such a way that they are suitable for the activities for which the tissue bank has been approved. You need to
offer the possibility of a logical sequence of the work steps to minimize the risk of errors, as well as effective cleaning and maintenance
allow to minimize the risk of contamination.
(2) A suitable level of air cleanliness must be maintained for the individual work processes. Cells or tissues are processed at
Environmental exposure, this must be done in an environment with speci fi ed air quality and cleanliness to avoid the risk of contamination, including the risk
the cross contamination between individual donations to keep as low as possible. The effectiveness of these measures must be validated and monitored.
(3) Unless otherwise provided for in paragraph 4, exposure of cells or tissues to the environment during processing is without
subsequent inactivation or sterilization process an air quality with a germ count and particle number according to level A of the definition of the current one
Guide to Good Manufacturing Practice, Appendix 1 to Directive 2003/94 / EC establishing the principles and guidelines of Good Manufacturing Practice for
Medicinal products for human use and for test preparations intended for use in humans, with one for the processing of the relevant cells or
Tissue suitable background environment, which is at least level D of the mentioned guide for good in terms of bacteria count and particle number
Manufacturing practice corresponds.
(4) It is possible to deviate from the requirements of paragraph 3 if
1. It is demonstrated that exposure to a level A environment has a deleterious effect on the required properties of the cells
or has tissue,
2. It is demonstrated that the way the cells or tissues are used by the recipient has a significantly lower risk of transmission
a bacterial or fungal infection on the recipient than in cell or tissue transplantation, or
3. It is not technically possible to carry out the required process in a level A environment.
The environmental conditions must be specified. It must be demonstrated and documented that the required quality and the required environment
Safety of the cells or tissues can be achieved, this taking into account the intended purpose, the type of use and
if applicable, the immune status of the recipient.
(5) Written hygiene and clothing regulations must be laid down for all work rooms and warehouses.
(6) Suitable clothing and equipment for personal protection and hygiene must be provided in all work and storage rooms of the tissue bank.
(7) For the storage of cells and tissues, the storage conditions including relevant parameters such as temperature, humidity or
Air quality, which are necessary to maintain the required properties of the cells and tissues. Critical parameters are too
inspect, monitor and record to demonstrate that the specified storage conditions are met.
(8) Storage facilities shall be provided which clearly separate cells and tissues which have not yet been released or
distinguish between those that have been released and those that have been rejected to avoid confusion and cross-contamination. Spatially separated areas or
Storage devices or the safe separation within the storage device are both in the quarantine and in the release storage area for
to maintain certain tissues and cells according to specific criteria.
(9) Tissue banks must have written instructions and procedures for access controls, cleaning and maintenance, waste disposal and
the behavior in an emergency.
equipment
Section 5
be available in sufficient numbers to ensure processing, storage and distribution that is state of the art. The
Equipment must be selected in such a way that a hazard to the cells or tissues, the recipient and / or the personnel is excluded as far as possible or
is reduced to the non-excluded minimum.
(2) The equipment, which is critical with regard to the product quality, must be identified and qualified according to the intended use,
undergo regular inspections and maintain according to the manufacturer's instructions. New and repaired equipment must be closed before commissioning
testing. The test results must be documented.
(3) If critical processing or storage parameters are affected by the equipment, these are to be determined and must be more appropriate
Monitoring, warning, alarm or corrective measures, so that malfunctions and defects are identified and thus it is ensured that the
critical parameters are kept within defined limits at all times. Maintenance, repair, cleaning, disinfection and decontamination
All critical equipment must be carried out regularly and documented accordingly. There must be procedures for operating each part of the critical
Equipment is available that details what action to take in the event of malfunction or failure.
(4) Scales, weights and other measuring devices are last changed by the according to the measure and calibration law, Federal Law Gazette № 152/1950
Federal Laws BGBl. I № 137/2004 and BGBl. I № 6/2007. According to the result of a risk analysis as critically de fi ned measuring devices that
do not fall under the measurement and calibration law, must be appropriately qualified and calibrated.
(5) For all activities, the speci fi cations of all critical equipment and reagents as well as speci fi cations for the packaging material must be specified
become. Critical equipment and reagents must meet documented requirements and speci fi cations and, if necessary, the requirements
of the Medical Devices Act, BGBl. № 657/1996, last amended by the Federal Laws BGBl. I № 153/2005 and BGBl. I № 6/2007, the directive
93/42 / EEC of the Council of 14 June 1993 on medical devices and Directive 98/79 / EC of the European Parliament and of the Council of 27 October 1998
via in vitro diagnostics or - when procured in third countries - meet equivalent standards.
(6) Documents on the inventory of equipment as well as on the quali fi cation, cleaning and maintenance (device-specific data) are from the last
keep dated signature for at least five years.
industrial hygiene
§ 6. (1) Precautions must be taken to ensure that cells and tissues are not adversely affected by external influences.
(2) This precaution in accordance with paragraph 1 must be carried out according to a hygiene program which must be carried out in the tissue bank. The instructions are so too
design to prevent contamination of equipment, cells and tissues and packaging material.
(3) The hygiene program must at least contain:
1. Instructions on the hygienic behavior during receipt, processing, testing, storage and distribution as well as information on the
using work clothes,
2. instructions on the cleaning and disinfection measures to be carried out, their frequency and the devices and aids to be used,
3. Information about those responsible for cleaning or disinfection and those responsible for the proper performance of these activities
persons authorized to issue instructions, and
4. Instructions on how to dispose of waste, including information about who is responsible for disposal and how to properly dispose of it
Activities of responsible persons authorized to issue instructions.
(4) The hygiene program is, insofar as it is to be observed by them, all persons working in the tissue bank and the persons within the meaning of para. 3 no. 3 and
4 before the start of their work, after every change in the hygiene program and subsequently at least once a year.
(5) Waste water, waste and other residues in and out of the work rooms and their immediate surroundings are safe and hygienic
dispose.
documentation
§ 7. (1) Tissue banks must have set up a system that ensures comprehensive and correct documentation for all activities. The system
must ensure that all work steps are standardized and that all work steps, in particular with regard to acceptance, processing, storage,
Transport, distribution or disposal, including aspects of quality control and quality assurance are comprehensible. The documents must be clear
be clear, error-free and up to date and checked regularly.
(2) For each critical activity, the appropriate materials and equipment, as well as the personnel involved, must be defined and documented.
(3) All changes to documents must be checked, dated, approved, documented and immediately authorized personnel
to implement. A document control procedure for the chronology of document reviews and changes must be set up, which ensures
that only the current versions of the documents are used.
(4) If documents are not recorded in writing, but with electronic, photographic or other data processing systems, the
Tissue bank validate the system beforehand by demonstrating that the data is correct during the expected retention period
be secured. These data stored with such systems must be made available in a legible form at all times and are therefore
Submit to the Federal Office for Safety in Health Care on request. Electronically stored data must take appropriate measures such as duplication
or backup and transfer to another storage system can be protected against data loss or damage. These measures must
be understandable.
(5) Without prejudice to Paragraph 6, all records, including raw data that are critical for the safety and quality of the tissues and cells, are subject to this condition
document that access to this data is ensured at least ten years after the expiry date, clinical use or disposal
is.
(6) Tissue banks must store the data in accordance with the system in a suitable and readable data archive for at least 30 years.
quality assurance
§ 8. (1) Tissue banks are obliged to carry out an audit at least every two years with regard to all activities for which the tissue bank has been approved
to have independent, competent and appropriately trained persons carried out. These have to check whether the regulations of the GSG and these
Ordinance and the provisions of the operating license are complied with and all activities in accordance with the state of the art in science and technology
be carried out. The results of the audit and proposed corrective measures must be documented.
(2) Deviations from the required quality or safety standards are to be examined and evaluated and it is based on the evaluation
Make a decision about necessary corrective and preventive measures.
(3) Corrective measures are to be implemented without unnecessary delay. The implementation must be documented. Preventive and corrective measures are post
check their effectiveness for their introduction.
Receiving cells and tissues
§ 9. (1) All inputs of cells or tissues are to be checked upon acceptance to determine whether the delivery including the transport conditions
Packaging, labeling including the associated documents and reserve samples of the donors comply with the regulations of
Tissue Removal Equipment Ordinance (GEEVO), Federal Law Gazette II № 191/2008, and corresponds to the speci fi cations of the tissue bank. Inputs that meet these requirements
do not correspond, must be segregated. They are to be discarded if, based on the deviations, it can be assumed that according to the state of the art and
Technology that cells or tissues are not suitable for use in humans.
(2) Tissue banks must have written standard operating instructions (SOPs) against which each individual receipt is checked; further about
SOPs for handling and segregating inputs that do not meet the requirements or whose test results are incomplete, for each
Avoid risk of contamination.
(3) This review, including the decision on release for further processing or storage for distribution, must be carried out by one
qualified and named person. Until the result of this test is available, the entrances must be stored under quarantine conditions
become.
(4) tissue banks must
1. Document the following data regarding germ cells intended for partner donation:
a) the consent, also with regard to the purpose or purposes for which the tissues or cells may be used as well as other speci fi c
Disposal instructions if the tissues or cells are not used for the purpose for which consent has been given
b) Donor identity and characteristics: type of donor, age, gender, presence of risk factors,
c) partner identity,
d) place of extraction and
e) Tissues and cells removed and relevant characteristics.
2. With regard to all other inputs, the data in accordance with Section 6 (3)
document the GEEVO.
(5) Donor samples should be kept for the period based on a risk assessment from the tissue bank
was set.
processing
§ 10. (1) Critical processing steps that affect quality and safety are to be specified and validated in manufacturing regulations, they may
Do not allow cells or tissues to become clinically ineffective or harmful to the recipient. The validation can be based
1. on studies carried out by the tissue bank itself,
2. on data from publications, or
3. In the case of established processing methods, subsequent evaluation of the clinical results for the cells or tissues distributed by the tissue bank.
(2) The processing steps are to be defined in SOPs that correspond to the validated method and are documented in accordance with § 7.
(3) It must be ensured that all processing steps in accordance with the approved processing methods, in accordance with the manufacturing regulations and the SOPs
be performed. The staff must be trained accordingly.
(4) If the cells or tissues are subjected to an inactivation or sterilization process, this must be specified, documented and validated.
(5) Significant changes to critical processing steps must be validated and documented before they are introduced.
(6) The processing steps are to be evaluated regularly to ensure that they continue to achieve the specified results.
(7) The procedures for separating cells or tissues must contaminate other donations and products, the processing environment and
of personnel.
Storage and release of the products
§ 11. (1) The maximum storage period must be specified for each type of storage condition. The selected period must include the possible one
Take into account the deterioration of the required cell and tissue properties.
(2) A cell and tissue inventory system must be in place to ensure that they cannot be released for distribution before
all the requirements set out in this regulation are met. SOPs must be available which describe the circumstances and the procedure for the release of cells
or precisely define fabrics for distribution. The release must be made in writing by the responsible person in accordance with § 9 GSG.
(3) At all stages of processing, a system for the identification of cells and tissues must have clearly released products from non-released (in
Quarantined) and discarded products.
(4) Products must meet the specified speci fi cations before they are released for distribution. Any deviation from written
Specifications or laboratory controls as well as any deviations from laboratory results must be examined, justified and documented in writing.
(5) From the release documentation, it must be clear that, before cells or tissues are released, all requirements according to this
Ordinance that all current registration forms, relevant medical records, processing records and
The results of laboratory controls have been checked by the responsible person in accordance with a written procedure in accordance with § 9 GSG.
(6) The responsible person in accordance with § 9 GSG must change or be significantly changed after the introduction of new donor selection or test criteria
Processing steps a documented risk assessment regarding the quality or safety of all already stored tissues and cells and regarding their
carry out further use.
distribution
§ 12. (1) Critical transport conditions such as temperature and maximum duration to maintain the required tissue and cell properties are to be specified.
(2) The container for the final packaging must be secure and ensure that the quality of the tissues and cells corresponds to the specified
Conditions. The safety and practicality of all containers must be validated.
(3) If the transport is carried out by third parties, the tissue bank must conclude a written agreement with them to ensure that the
necessary conditions are met.
(4) Procedures for dealing with requests for tissues and cells must be in place. The rules for the allocation of tissues and cells
certain patients or healthcare facilities are to be documented and made available on request.
(5) There must be SPOs for handling returned products, including any criteria for their resumption in
the stock.
Label for distribution
§ 13. (1) The primary packaging for cells or tissues must contain the following information:
1. type of cells and tissues and, if applicable, lot or batch number,
2. identification of the tissue bank,
3. the Uniform European Code of cells and tissues distributed for use in humans or the donation recognition sequence of the for
Traffic-released cells and tissues that are not distributed for use in humans
4. for autologous donation: "ONLY FOR AUTOLOGICAL USE", and details of donor / recipient and
5. the indication "BIOLOGICAL HAZARD" if a product is known to have a positive test result for a marker of a relevant one
Infectious disease.
If one of the information according to Z 3 and 4 can not be given on the primary packaging, it must be stated on a separate sheet that the
The primary packaging must be attached in such a way that the clear assignment is retained.
(2) The following information must be provided either on the primary packaging or in the accompanying documents:
1. Description (definition) and, if applicable, dimensions of the tissue or cell product,
2. if applicable, morphology and functional data,
3. Date of tissue / cell distribution,
4. results of biological tests on the donor,
5. Storage recommendations,
6. Instructions for opening the container, the packaging and any necessary handling / reconstitution,
7. expiry dates after opening / handling,
8. Instructions for reporting serious undesirable reactions or incidents in accordance with the Tissue Vigilance Ordinance, Federal Law Gazette II No. 190/2008,
9. Presence of potentially harmful residues and
10. in the case of imported cells and tissues from third countries, the country in which they were obtained and the exporting country (if different from the country of
Recovery).
(3) The primary packaging must be transported in an outer packaging, which must contain the following information:
1. the identification of the tissue bank, including address and telephone number,
2. the identifier of the destination responsible for human use, including address and telephone number,
3. the inscription "CAUTION TISSUE AND CELLS",
4. If living cells are required for the transplantation, the inscription: "DO NOT IRRADIATE" must be added
5. Recommended transport conditions (eg "KEEP COOL", "KEEP STORED"), and
6. Safety instructions / cooling procedures, if applicable.
Use of the Single European Code
§ 13a. (1) Tissue banks have after receiving the cells and tissues in accordance with § 12 para. 3 GSG, Federal Law Gazette I No. 49/2008, or when importing
Allocate a donation identification sequence to a third country supplier.
(2) Tissue banks have to assign a new donation identification number to the final product for pooled cells and tissues and the
Ensure traceability to individual donations.
(3) The donation identification sequence may no longer be changed if it has been allocated to cells and tissues released for traffic.
Coding errors must be corrected and every correction must be fully documented.
(4) Tissue banks must have one of the permitted product coding systems and the latest before distribution for use in humans
to apply corresponding product numbers for the tissues and cells from the EU Compendium of Cell and Tissue Products.
(5) Tissue banks must use a suitable split number and an expiry date.
recall
§ 14. (1) Quali fi ed personnel within the tissue bank must be instructed to assess the need for a recall and the necessary ones
Initiate and coordinate measures.
(2) There must be an effective recall procedure, including a description of the responsibilities and the measures to be taken.
These also include reporting to the Federal Office for Safety in Health Care in accordance with section 17 (3) GSG.
(3) Measures such as the tracking and, if necessary, tracing of all relevant tissues and cells are to be carried out within predetermined periods
take. These measures identify those donors who may have contributed to causing the recipient's response to available ones
Identify tissues and cells from these donors and inform supplied facilities about the potential risk.
Reference to European Union legal acts
§ 15. By this ordinance
1. Directive 2006/86 / EC implementing Directive 2004/23 / EC with regard to traceability requirements, reporting more serious
Incidents and undesirable reactions as well as certain technical requirements for coding, processing, preservation, storage and
Distribution of human tissues and cells, OJ. L 294, 25.10.2006 p. 32,
2. Directive 2006/17 / EC for the implementation of Directive 2004/23 / EC with regard to technical regulations for the donation, procurement and testing of
human tissues and cells, OJ. No.L 35 from 02/09/2006 p. 40 and
3. Directive (EU) 2015/565 amending Directive 2006/86 / EC with regard to certain technical regulations for the coding of human beings
Tissues and cells, OJ. No.L 93 from 04/09/2015 p. 43
implemented.
Come into effect
Section 16. Section 7 (6), Section 13 (1) and (2) 8, 9 and 10, Section 13a including the heading, Section 15 including the heading and the annex in the version of the Ordinance BGBl. II
No. 18/2017 take effect on April 29, 2017.
investment
Information from the tissue bank
1. Donor identification
2. Donation ID, which includes at least the following:
- Identification of the removal device (with contact details) or tissue bank
- Unique donation number
- date of procurement
- place of procurement
- Type of donation (e.g. single vs. multiple tissue donation, autologous vs. allogeneic; living donation vs. postmortem donation)
3. Product identifier, which includes at least the following:
- Identification of the tissue bank
- Type of tissues and cells / product (basic nomenclature)
- Pool number (with pooled material)
- split number (if available)
- expiry date (if available)
- Tissue / cell status (i.e. quarantined, ready to use, etc.)
- Description and origin of the products, processing steps, material and additives that come into contact with the tissues and cells and
affect their quality and / or safety
- Identifier of the organization that will carry out the final identification
4. Single European Code (if available)
5. Human use identifier, which includes at least the following:
- Date of distribution / disposal
- User ID
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