192. Ordinance of the Federal Minister for Health, Family and Youth, which sets out more detailed rules for the operation of tissue banks (tissue banking regulation-GBVO)

On the basis of § 30 of the tissue safety law, BGBl. I n ° 49/2008, shall be ordered:

Scope

§ 1. (1) This Regulation shall apply to the operation of tissue banks in accordance with § 2 Z 15 of the tissue safety law (GSG), BGBl. N ° 49/2008.

(2) The General Workers ' Protection Regulation, BGBl. No 218/1983, as last amended by the BGBl Regulation. II No 77/2007, and the Regulation on biological agents, BGBl. II No 237/1998, shall not be affected by this Regulation.

(3) The definitions of § 2 GSG shall also apply to this Regulation.

Quality system

§ 2. (1) The quality management of tissue banks shall include all coordinated activities for the management and control of a tissue bank in relation to quality at all levels.

(2) Quality shall be sought by all persons involved in the work processes of the tissue bank, whereby the management and the responsible person according to § 9 GSG shall have a systematic quality claim and the introduction and maintenance of a quality system.

(3) The function of the quality management system must be regularly reviewed in order to make continuous and systematic improvements possible.

(4) All written instructions, procedural instructions, specifications, manufacturing instructions, standard operating instructions (SOPs) and other relevant documents related to the reception, processing, testing, storage and Distribution of cells and tissues shall be approved by the responsible person by signature.

Staff

§ 3. (1) tissue banks must have sufficient qualified staff to be able to carry out the activities for which they have been authorised.

(2) The staff must be trained before the start of the activity, as well as in the event of changes to the procedures or new scientific knowledge, and must be given sufficient opportunities for the appropriate professional development. The training programmes must ensure that all staff are competent in carrying out the tasks assigned to them, and that they have sufficient knowledge and understanding of the scientific/technical procedures and procedures, and They shall have principles relevant to the tasks assigned to them, the organisational framework, the quality system and the health and safety requirements of the institution in which they work, and shall be sufficiently informed of the other ethical and legal aspects of their work. Records shall be kept on the training measures. The staff of the staff shall be regularly evaluated within the framework of the quality system.

(3) The tasks and responsibilities shall be defined in an organisation scheme.

(4) The tasks and responsibilities of personnel in tissue banks shall be defined in function descriptions which shall be regularly updated.

(5) The function descriptions and organisational schemes shall be approved in accordance with internal procedures.

(6) The responsible person is in addition to the tasks in accordance with § 11 and the tasks within the framework of the tissue vigilance ordinance, BGBl. II No 190/2008, responsible for ensuring that the tissue bank is responsible for its obligations under para. 1 and 2, in the context of documentation, quality assurance, acceptance, processing, storage, marking, packaging and distribution of cells and tissues, as well as in relation to relations with third parties.

(7) The responsible person and all staff in a senior or responsible position shall be given sufficient powers to enable them to carry out their duties.

Premises

§ 4. (1) The premises shall be set up and shall be waiting for them to be suitable for the activities for which the tissue bank has been approved. You need to offer the possibility of a logical sequence of work steps to minimize the risk of error, and allow effective cleaning and maintenance to reduce the risk of contamination to a minimum.

(2) A suitable degree of air purity shall be maintained for the individual operations. If cells or tissues are processed at ambient exposure, this must be done in an environment with specified air quality and cleanliness, in order to avoid the risk of contamination, including the risk of cross-contamination between the cells and the individual donations, as low as possible. The effectiveness of these measures shall be validated and monitored.

(3) Unless otherwise provided in paragraph 4, in the event of exposure of cells or tissues to the environment during processing without subsequent inactivation or sterilisation process, an air quality with a germ count and/or germ count shall be provided. Number of particles corresponding to Stage A of the definition of the current Guide to Good Manufacturing Practice, Annex 1 to Directive 2003 /94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for the purpose of establishing the principles and guidelines for good manufacturing practice for medicinal products for human use Use in humans requires certain investigational medicinal products, with one for processing of the cells or tissues concerned, which corresponds to at least stage D of the said guide for good manufacturing practice with respect to the number of germs and the number of particles.

(4) The requirements of paragraph 3 may be dismissed if:

1.		is demonstrated that exposure to a stage A environment has adverse effects on the required properties of the cells or tissues;
2.		it is demonstrated that the use of cells or tissues in the recipient involves a significantly lower risk of transmission of a bacterial or fungal infection to the recipient than in the case of cell or tissue. tissue transplantation, or
3.		it is technically not possible to carry out the required procedure in an environment of stage A.
The environmental conditions must be specified. It shall be demonstrated and documented that the chosen environment can achieve the necessary quality and safety of cells or tissues, in particular taking into account the purpose of the intended purpose, the nature of the 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 are to be provided in all working and storage rooms of the tissue bank.

(7) Storage conditions, including relevant parameters such as temperature, humidity or air quality, are to be laid down for the storage of cells and tissues, which are necessary to provide the necessary properties of cells and tissues, to maintain. Critical parameters must be controlled, monitored and recorded in order to demonstrate that the specified storage conditions are met.

(8) Storage facilities are to be provided which clearly separate or distinguish cells and tissues that have not yet been released from those that have been released and which have been discarded in order to avoid confusion and cross-contamination. Spatially separated areas or storage devices or the safe separation within the storage device are to be kept for specific tissues and cells in accordance with special criteria, both in the quarantine and the release agation areas.

(9) tissue banks must have written instructions and procedures for access control, cleaning and maintenance, waste management and emergency response.

Equipment

§ 5. (1) The equipment, such as machinery and instruments, as well as other operating and auxiliary equipment, must be suitable for the work to be carried out and must be present in sufficient numbers, so that a state-of-the-art equipment must be provided. Processing, storage and distribution are guaranteed. The equipment shall be selected in such a way that the cells or tissues, the consignee and/or the staff are not placed at risk, if possible, or are reduced to the non-exclusive minimum.

(2) The equipment which is critical in terms of product quality must be identified and qualified in accordance with the intended use, regular inspections shall be carried out and, in accordance with the manufacturer ' s instructions, to wait. New and repaired equipment must be tested before commissioning. The test results are to be documented.

(3) If critical processing or storage parameters are affected by the equipment, these are to be determined and must be the subject of appropriate monitoring, warning, alarm and/or alarm systems. To ensure that the critical parameters are kept within defined limits at any given time, corrective measures should be taken to detect malfunctions and defects. Maintenance, repair, cleaning, disinfection and decontamination of all critical equipment must be carried out on a regular basis and documented accordingly. There must be procedures for the operation of each part of the critical equipment, which shall specify in detail the measures to be taken in the event of malfunctions or failure.

(4) Waages, weight pieces and other measuring devices are according to the measure and calibration law, BGBl. No. 152/1950, as last amended by the Federal Laws BGBl. I n ° 137/2004 and BGBl. I n ° 6/2007. According to the result of a risk analysis as critically defined measuring devices, which do not fall under the measure and calibration law, must be appropriately qualified and calibrated.

(5) For all activities, the specifications of all critical inputs and reagents, as well as specifications for the packaging material, shall be defined. Critical equipment and reagents must comply with documented requirements and specifications and, if necessary, comply with the requirements of the Medical Devices Act, BGBl. No. 657/1996, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, Council Directive 93 /42/EEC of 14 June 1993 on medical devices and Directive 98 /79/EC of the European Parliament and of the Council of 27 June 1993 on medical devices and on medical devices. The European Parliament and the Council of the European Union, the European Parliament and the Council of 27 October 1998 on in-vitro diagnostic medical devices or, in the case of procurement

(6) Documents on the stock of equipment and on qualification, cleaning and maintenance (device-specific data) shall be kept for at least five years from the last date of signature.

Operating hygiene

§ 6. (1) It is necessary to ensure that cells and tissues are not adversely affected by external influences.

(2) This provision in accordance with paragraph 1 shall be carried out in accordance with a hygiene programme, which must be placed in the tissue bank. The instructions shall be designed to prevent contamination of equipment, cells and tissues and packaging material.

(3) The hygiene programme shall at least contain:

1.		Instructions for the hygienic behaviour in the reception, processing, testing, storage and distribution, as well as information on the work clothes to be used,
2.		Instructions on the cleaning and disinfection measures to be carried out, their frequency and the equipment and tools to be used,
3.		particulars of persons responsible for cleaning or disinfection and those responsible for the proper conduct of those activities; and
4.		Instructions for the disposal of waste, including information on the authorising officers responsible for disposal and responsible for the proper conduct of those activities.

(4) The hygiene programme shall, in so far as it has to be observed by them, be all persons working in the tissue bank and the persons referred to in paragraph 3 (3) (3) and (4) before commencement of their activities, after any change in the hygiene programme, and subsequently at least to be verifiably brought to the attention once a year.

(5) Waste water, waste and other residues in and out of the working spaces and their immediate environment shall be disposed of in a safe and hygienic manner.

Documentation

§ 7. (1) tissue banks must have set up a system that ensures comprehensive and accurate documentation for all activities. The system must ensure that all work steps are standardised and that all work steps, in particular in respect of the removal, processing, storage, transport, distribution or disposal, including the aspects of the Quality control and quality assurance are traceable. The documents shall be clear, clear, error-free and up-to-date, and shall be reviewed regularly.

(2) For each critical activity, the appropriate materials and equipment, as well as the personnel involved, shall be defined and documented.

(3) All changes to documents shall be reviewed, dated, approved, documented and immediately implemented by authorized personnel. It is necessary to establish a document control procedure for the chronology of the document reviews and changes, 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 must first validate the system by demonstrating that the data during the period of the expected retention period. These data stored with such systems must be made available at any time in a legible form and must be submitted to the Federal Office for Health and Safety in the Health Care Sector on request. Electronically stored data must be protected against data loss or damage by appropriate measures such as duplication or back-up and transfer to another storage system. These measures must be comprehensible.

(5) Without prejudice to paragraph 6, all records, including raw data critical to the safety and quality of tissues and cells, shall be documented in such a way that access to these data shall be at least ten years after the expiry date, the Clinical use or disposal is ensured.

(6) In any case, the following data, which are used for traceability, must be kept for at least 30 years:

1.		Donor identifier, which includes at least the following:
a)			Identification of the removal device,
b)			unique identification code (ISBT 128),
c)			date of collection,
d)			Place of extraction, and
e)			Type of donation.
2.		Product identifier, which includes at least the following:
a)			Identification of the tissue bank,
b)			Type of tissue and cells/product (basic nomenclature),
c)			(if appropriate) pool number,
d)			(possibly) split number,
e)			Expiry date,
f)			Tissue/cell status, and
g)			Description and origin of the products, processing steps, materials and additives which come into contact with the tissues and cells and have an effect on their quality and/or safety.
3.		Identification of products released for use in humans, comprising at least the following:
a)			date of distribution/disposal, and
b)			Identifier of the user.

Quality assurance

§ 8. (1) tissue banks shall be obliged to have an audit carried out at least every two years in respect of all the activities for which the tissue bank has been approved by independent, expert and appropriately trained persons. They shall verify compliance with the provisions of the GSG and this Regulation, as well as the provisions of the operating licence, and shall carry out all the activities in accordance with the state of the art and technology. The results of the audit and proposed corrective measures must be documented.

(2) Deviations from the necessary quality or safety standards shall be investigated and evaluated and a decision on necessary corrective and preventive measures shall be taken on the basis of the evaluation.

(3) Corrective measures shall be implemented without unnecessary delay. The implementation is to be documented. Preventive and corrective measures must be reviewed after their introduction to their effectiveness.

Acceptance of cells and tissues

§ 9. (1) All inputs of cells or tissues shall be checked at the time of the transfer to the extent that the delivery, including the transport conditions, the packaging, the marking, including the related documents and the rehearsals of the dispensers, shall be examined. The provisions of the tissue collection regulation (GEEVO), BGBl. II, No 191/2008, and the specifications of the tissue bank. Inputs that do not comply with these specifications are to be removed. They shall be discarded if, on the basis of the deviations, it is to be assumed that, according to the state of the sciences and technology, the cells or tissues are not suitable for use in humans.

(2) tissue banks must have written standard operating instructions (SOPs) for each individual entrance to be checked; furthermore, SOPs shall be used for handling and disposal of entrances which do not comply with the specifications or whose Test results are incomplete in order to avoid any risk of contamination.

(3) This review, including the decision on release for further processing or storage for distribution, must be carried out by a person qualified and named for this purpose. Until the result of this test, the entrances must be stored under quarantine conditions.

(4) tissue banks must:

1.		in respect of germ cells which are intended for partner donation, the following data are documented:
a)			consent, including in relation to the purpose and/or the purposes for which the tissues and/or Cells may be used as well as other specific instructions for disposal, if the tissues or tissues are used. 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)			Parttime identity,
d)			Place of extraction and
e)			Removed tissues and cells and relevant characteristics.
2.		document the data according to § 6 (3) of the GEEVO with regard to all other entrances.

(5) Return samples from donors must be kept for at least 30 years.

Processing

§ 10. (1) Critical processing steps that affect quality and safety shall be defined and validated in manufacturing regulations, they shall not allow the cells or tissues to be clinically ineffective or harmful to the recipient. Validation can be based on

1.		on studies carried out by the tissue bank itself,
2.		to data from publications, or
3.		in the case of established processing methods for subsequent evaluation of the clinical results for the cells or tissues distributed by the tissue bank.

(2) The processing steps shall be defined in SOPs, which correspond to the validated method and are documented in accordance with § 7.

(3) It is necessary to ensure that all processing steps are carried out in accordance with the approved processing procedures, in accordance with the manufacturing procedure and the SOPs. 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) Essential changes in critical processing steps must be validated and documented prior to their introduction.

(6) The processing steps shall be regularly evaluated to ensure that they continue to achieve the specified results.

(7) The procedures for the secretion of cells or tissues must avoid the contamination of other donations and products, the processing environment and the staff.

Storage and release of products

§ 11. (1) For each type of storage condition, the maximum storage period shall be specified. The selected period of time must, among other things, take into account the possible deterioration of the required cell and tissue properties.

(2) There must be an inventory system for cells and tissues which ensures that they cannot be released for distribution before all the requirements laid down in this Regulation are met. SOPs need to be present, which determine the circumstances and the procedure for the release of cells or tissues for distribution. The release has to be made in writing by the responsible person according to § 9 GSG.

(3) At all stages of processing, a system for identifying cells and tissues must distinguish clearly released products from non-released (quarantined) and segregated products.

(4) Products must comply with the specified specifications prior to their release for distribution. Any deviation from written specifications or laboratory checks as well as any deviation from laboratory results shall be investigated, substantiated and documented in writing.

(5) The clearance documentation must show that before cells or tissues are released, all the requirements of this Regulation have been met, in particular that all current mildeva prints, relevant medical Records, processing records and results of laboratory checks have been verified according to a written procedure by the responsible person in accordance with § 9 of the GSG.

(6) The responsible person according to § 9 GSG must, after the introduction of new donor selection or test criteria or significantly altered processing steps, a documented risk assessment with regard to the quality or safety of all already shall be carried out and shall be carried out for further use.

Distribution

§ 12. (1) Critical transport conditions such as temperature and maximum duration to maintain the required tissue and cell properties shall be laid down.

(2) The container for the final packaging must be safe and shall ensure that the quality of the tissues and cells is maintained in accordance with the conditions laid down. The safety and usefulness of all containers shall be validated.

(3) If the transport is carried out by third parties, the tissue bank shall conclude a written agreement with them in order to ensure that the necessary conditions are met.

(4) There must be procedures for dealing with requests for tissues and cells. The rules for the allocation of tissues and cells to certain patients or health care institutions must be documented and made available on request.

(5) SPOs must be in place for the handling of returned products, including, where appropriate, criteria for their resumption into the stock.

Label for distribution

§ 13. (1) The primary packaging for cells or tissues shall bear the following information:

1.		Type of tissue and cells, unique identification code (ISBT 128) and, where applicable, lot or batch number,
2.		Identification of the tissue bank,
3.		Expiry date,
4.		in the case of autologous donation: "ONLY FOR AUTOLOGOUS USE", and indication of donor/recipient,
5.		"BIOLOGICAL HAZARDS", if a product is known to have a positive test result for a marker of a relevant infectious disease.
If any of the information referred to in Z 1 to 5 cannot be indicated on the primary packaging, it shall be indicated on a separate sheet which shall be inseparably attached to the primary packaging.

(2) The following information shall be disclosed either on the primary packaging or in enclosed documents:

1.		description (definition) and, where appropriate, the dimensions of the tissue or cell product,
2.		where appropriate, morphology and functional data,
3.		Date of tissue/cell distribution,
4.		Results of biological tests in donors,
5.		Inventory recommendations,
6.		Instructions for opening the container, packaging and, where appropriate, required handling/reconstitution,
7.		Case data after opening/handling,
8.		Guidance on reporting serious adverse reactions or incidents in accordance with the Ordinance on Tissue Vigilance, BGBl. II No 190/2008, and
9.		Presence of potentially harmful residues.

(3) The primary packaging shall be transported in an outer packaging, which shall bear the following information:

1.		the identifier of the tissue bank, including address and telephone number,
2.		the identification of the determination facility responsible for human use, including address and telephone number,
3.		the inscription "CAUTION TISSUE AND CELLS",
4.		where living cells are needed for transplantation, the inscription: "DO NOT IRRADIATE" '
5.		recommended transport conditions, (eg "Keep refrigerated", "Keep upright"), and
6.		Safety instructions/optional cooling procedures.

Recall

§ 14. (1) Within the tissue bank, qualified personnel must be instructed to assess the need for a recall and to initiate and coordinate the necessary measures.

(2) There must be an effective call-back procedure, including a description of the responsibilities and measures to be taken. These also include the notification to the Federal Office for Health Security in accordance with Section 17 (3) of the GSG.

(3) Measures such as the prosecution and, where appropriate, tracing of all relevant tissues and cells shall be taken within predetermined periods of time. These measures shall identify those donors who may have contributed to the causation of the response to the recipient in order to identify available tissues and cells from those donors, and to provide facilities for the delivery of the relevant tissues and cells to the recipient. Hazard to be informed.

References to acts of the European Community

§ 15. This Regulation shall

1.		Commission Directive 2006 /86/EC of 24 June 2007 on the October 2006 on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards requirements for traceability, reporting of serious incidents and adverse reactions, as well as certain technical Requirements relating to the coding, processing, preservation, storage and distribution of human tissues and cells, OJ L 327, 30.4.2002, p. No. OJ L 294, 25. October 2006 S 32, and
2.		Commission Directive 2006 /17/EC of 8 February 2006 on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards technical requirements for the donation, procurement and testing of human tissues and Cells, OJ. No. OJ L 38, 9 February 2006 p. 40,
.

Kdolsky