192. Regulation of the Federal Minister for health, family and youth, with the detailed arrangements for the operation of tissue banks are taken (tissue bank regulation - GBVO)
On the basis of § 30 of the tissue Safety Act, Federal Law Gazette I no. 49/2008, is prescribed:
§ 1 (1) this Regulation shall apply to the operation of tissue banks referred to in § 2 Z 15 of the tissue safety law (GSG), Federal Law Gazette I no. 49/2008.
(2) the General Labour Protection Ordinance, BGBl. No. 218/1983, as last amended by the regulation BGBl. II No 77/2007 and regulation biological agents, Federal Law Gazette II No. 237/1998, are not affected by this regulation.
(3) the definitions of § 2 GSG shall apply to this regulation.
2. (1) includes the quality management of tissue banks all coordinated activities to direct and control of a tissue bank with regard to quality at all levels.
(2) quality is to pursue by all persons involved in the processes of tissue bank, whereby the Managing Director and the person responsible in accordance with § 9 GSG ensure a systematic quality and the introduction and maintenance of a quality system.
(3) the function of the quality management system must be checked regularly to enable continuous and systematic improvement.
(4) all written instructions, procedures, specifications, manufacturing specifications, standard operating procedures (SOPs) and other relevant documents relating to the receipt, processing, testing, storage and distribution of cells and tissues are to be approved by signature of the responsible person.
Tissue banks must have § 3 (1) sufficient qualified personnel, to perform the activities, for which they were granted.
(2) staff must be trained prior to commencement of activities and change of procedures or new scientific evidence, as well as receive sufficient opportunities to the appropriate professional development. Training programs must ensure that all staff performing the tasks assigned to them have proved competent, sufficient knowledge and understanding of the scientific and technical procedures and principles have, which for the assigned tasks are relevant to them, understand the organisational framework, quality system and the health and safety regulations of the institution in which they work and are sufficiently informed of the wider ethical and legal context of their work. There are records to lead about the training. The expertise of staff is regularly within the framework of the quality system to evaluate.
(3) the duties and responsibilities are set in an organization chart.
(4) the duties and responsibilities of the personnel in tissue banks must be set in function descriptions which are regularly to update.
(5) the function descriptions and organization schemes shall be approved according to manufacturer's internal procedures.
(6) the person in charge is in addition to the tasks referred to in article 11 and the tasks in the framework of the Gewebevigilanzverordnung, BGBl. II Nr 190/2008, responsible for ensuring that the tissue bank their obligations under paragraphs 1 and 2, in the context of documentation, quality assurance, for the receipt, processing, storage, labelling, packaging and distribution of cells and tissues, as well as in the context of relations to third party meets.
(7) the person in charge and all employees in managerial and are sufficient powers to grant, so that they can fulfil their tasks.
The rooms are 4 (1) to set up and maintain that they are appropriate for the activities for which the tissue bank was approved. You must allow a logical sequence of steps to minimize the risk of errors and permit effective cleaning and maintenance in order to reduce the risk of contamination to a minimum.
(2) for each work operation to maintain an appropriate degree of air purity. The processing of cells or tissues during environment exposure, this must be done in an environment with specified air quality and cleanliness, to the risk of contamination, to keep the risk of cross-contamination between individual donations, as low as possible. The effectiveness of these measures is to validate and monitor.
(3) unless it is otherwise provided in subsection 4, an air quality with a bacterial count and number of particles according to level A of the definition of the current Guide to good manufacturing practice, annex 1 to the Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products and for investigational medicinal products intended for use in humans is required for exposure of cells or tissues to the environment during processing without subsequent inactivation or sterilization process , with a background environment appropriate for the processing of the concerned cells or tissue, which corresponds to at least the level D of the mentioned Guide to good manufacturing practice as regards plate count and number of particles.
(4) the requirements of paragraph 3 may be derogated from, if
1. is that exposure to an environment of the level A has adverse effects on the required properties of the cells or tissue, 2 is shown a significantly lower risk of transmission of bacterial or fungal infection on the receiver comes with the manner in which the use of the cells or tissue in the recipient as in the cell or tissue transplantation, or 3 it is technically not possible proved , perform the required procedure in an environment of A level.
The conditions are to be specified. It is to demonstrate and document that the required quality and safety of the cells or tissue can be achieved by the selected environment, this in particular taking into account the purpose of the provision, the type of use and, where appropriate, of the immune status of the receiver.
(5) for all work areas and storage are written hygiene and dress code set.
(6) in all working and storage areas of the tissue bank, suitable clothing and equipment for personal protection and hygiene are to deploy.
(7) for the storage of cells and tissues are the storage conditions including relevant parameters such as temperature, humidity or air quality, to determine which are necessary to the required properties of the cells and tissues, to maintain. To control, monitor and record, to prove that the specified storage conditions are critical parameters.
(8) there are storage facilities to provide, which is clearly from those cells and tissues that have not yet been released or distinguish have been released and discarded, to avoid mix-ups and cross-contamination. Geographically separate areas or storage devices or the secure separation within the storage device are to hold in the quarantine, as well as in the shared storage area for specific tissues and cells according to special criteria.
(9) tissue banks must have written instructions and procedures for access control, cleaning and maintenance, waste disposal and the behaviour in case of an emergency.
§ 5 (1) the equipment, as machines and instruments, as well as other operating and AIDS must each suitable for the work being done and available in sufficient number be so that guarantees appropriate processing, storage and distribution are the State of the art. The equipment is to be selected, that a risk of the cells or tissues, the recipient and/or staff where possible is excluded or reduced to the non-excludable minimum.
(2) the equipment that is critical in terms of product quality, is to identify and to qualify according to the intended purpose, to undergo regular inspections and maintain according to the instructions of the manufacturer. New and repaired equipment should be tested before use. The test results shall be documented.
(3) critical processing or storage parameters are fitted touches, are to determine this and must monitoring, warning, alarm or corrective measures be subject to reasonable for malfunctions and defects identified and is in order to ensure compliance with the critical parameters at any time within defined limits. Maintenance, repair, cleaning, disinfection and decontamination of all critical equipment are regularly and appropriately documented. Procedures for the operation of any part of the critical equipment must exist, in detail indicating what measures in the event of malfunctions or failure are.
(4) scales, weights and other measuring equipment are in accordance with the measurement and calibration law, BGBl. No. 152/1950, as last amended by Federal Law Gazette I no. 137/2004 and Federal Law Gazette I no. 6/2007, to calibrate. According to the results of a risk analysis as critically defined measuring devices, not covered by the measure and calibration law, must be appropriately qualified and calibrated.
(5) for all activities, you must set the specifications of all critical equipment and reagents, as well as specifications for the packaging material. Critical resources and reagents must meet documented requirements and specifications and, where appropriate, the requirements of the medical devices act, Federal Law Gazette No. 657/1996, last amended by the Federal Law Gazette I no. 153/2005 and Federal Law Gazette I no. 6/2007, of Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, or - when a procurement in third countries - generally meet standards.
(6) records of the inventory of equipment, as well as the qualification, cleaning and maintenance (device-specific data) are for at least five years to be kept from the last dated signature.
6. (1) it is provision to meet that cells and tissues do not adversely affected by external influences.
(2) this provision in accordance with paragraph 1 has to be made, which must lie in the tissue establishment after a hygiene programme. The instructions are designed to prevent contamination of equipment, packaging material, cells and tissues.
(3) the sanitation program shall at least contain:
1. instructions on the hygienic behavior at the receipt, processing, testing, storage and distribution, as well as information on the working clothes to use, 2. commissioned instructions carried out cleaning and disinfection measures, their frequency and the devices to be used and tools that 3. responsible for information about cleaning or disinfection and weisungsbefugten persons responsible for the proper implementation of these activities, and 4. instructions for disposal of waste including details of the disposal and for the proper execution of these activities weisungsbefugten people in charge.
(4) the hygiene programme is, as far as note of these, at least once a year has been proven to bring all those involved in the tissue bank and the persons within the meaning of paragraph 3 Nos. 3 and 4 before starting their activity, after each change of the hygiene programme and as a result.
(5) waste water, waste and other debris are to be disposed of in a safe and hygienic way in and out of the working spaces and their immediate surroundings.
Tissue banks must have established a system 7 (1), which ensures a comprehensive and accurate documentation of all activities. The system must ensure that all procedures are standardized, and that all work steps, particularly with regard to collecting, processing, storage, transport, distribution or disposal, including aspects of quality control and quality assurance are understandable. The documents must be clear, clear, error-free and up-to-date, and are regularly reviewed.
(2) for each critical activity are to set the appropriate materials and equipment, as well as the it staff and documented.
(3) all changes to documents are to check, to date, to approve, to document and to implement immediately by authorised personnel. It is a document control procedure for the chronology of the document checks and changes to set up, which makes sure that only the latest versions of the documents are used.
(4) are documents not in writing, but with electronic, photographic or other recorded data processing systems, so the tissue bank must validate the system before by demonstrated that the data is properly backed up during the anticipated period of storage. The data stored with such systems can be exposed at any time in human-readable form and shall be provided by the Federal Office for security in health care at the request. Electronically stored data must be protected by appropriate measures such as duplication or back-up and transfer into another storage system against data loss or corruption. These measures must be comprehensible.
(5) without prejudice to paragraph 6 are all records, including raw data, which are critical to the safety and quality of tissues and cells, to document that the access to these data at least ten years after the expiry date, clinical use or disposal is ensured.
(6) in any case, following data that serve the traceability must be kept at least 30 years:
1. donor identification, which includes at least the following: a) identifier of the sampling device, b) unique identification code (ISBT 128), c) date of the extraction, d) place of production, and e) type of donation.
2. product identifier that shall include at least the following: a) identification of the tissue bank, b) type of tissues and cells / product (basic nomenclature), c) pool number (if applicable), d) split number (if applicable), e) expiry date, f) tissue / cell status, and g) description and origin of the product, carried out processing steps, materials and accessories that come with the tissues and cells in contact and affect their quality and/or safety.
3. identification of the products shared for use in humans, which includes at least the following: a) date of distribution/disposal, and b) identification of the user.
8. (1) tissue banks are required to perform an audit of all activities for which the tissue bank was approved, at least every two years through independent, professional and trained people. They have to verify compliance with the regulations of the GSG and this regulation and the provisions of the operating permit and all activities according to the level of performing science and technology. The results of the audit and proposed corrective actions must be documented.
(2) deviations from the required quality or safety standards are to examine and evaluate, and it is to take a decision on necessary corrective and preventive measures on the basis of the assessment.
(3) corrective actions are without undue delay. The implementation shall be documented. Preventive and corrective measures must be checked after its introduction on their effectiveness.
Receipt of cells and tissues
All inputs of cells or tissues are § 9 (1) in adopting amended to check to see if the delivery including the transport conditions, packaging, labelling including the related documentation and samples of donors the tissue extraction facility Regulation (GEEVO), Federal Law Gazette II No. 191/2008 and the specifications of the tissue establishment complies with. Inputs that do not meet these requirements, are to be separated. You have to discard if to assume on the basis of the differences is that the cells or tissues for use in humans are not suitable to the level of science and technology.
(2) tissue banks must have over written standard operating procedures (SOPs), enabling each individual input is checked; Furthermore SOPs for dealing with and the allocation of inputs, which do not comply with the requirements or whose test results are incomplete, to avoid any risk of contamination.
(3) this review including the decision on the release for further processing or storage for distribution must be made by qualified and designated individuals. The inputs under quarantine conditions must be stored pending the outcome of this test.
(4) tissue banks must
1 with regard to reproductive cells intended for partner donation that document following data: a) the consent, in relation to the purpose or purposes for which the tissues and cells may be used, as well as other specific instructions for disposal if the tissue or cells not used for the purpose for which the consent was given, b) donor identification and characteristics: type of donor , Age, sex, presence of risk factors, c) partner identity, d) place the extraction and e) extracted from tissues and cells and relevant characteristics.
2. with respect to all other inputs to document the data according to § 6 section 3 of the GEEVO.
(5) samples of the donor must be kept at least 30 years.
Critical processing steps that affect the quality and safety, are section 10 (1) to set in production rules and validate, they allowed the cells or tissue not clinically ineffective or harmful, will leave for the receiver. The validation can be based
1. in studies, the tissue bank itself has carried 2 data from publications, or 3.
Cells or tissues distributed at established processing procedures on subsequent evaluation of the clinical results for the tissue bank.
(2) that are processing steps in SOPs to set that correspond to the validated method and documented in accordance with § 7.
(3) it is to ensure that all processing steps in accordance with the approved processing procedures, in accordance with the production rules and the SOPs are carried out. The staff is to train accordingly.
(4) the cells or tissues undergo an inactivation or sterilization process, is to specify this, document and validate.
(5) significant changes of critical processing steps are to validate prior to their introduction and document.
(6) the processing steps are regularly assessed in order to ensure that they continue to achieve the specified results.
(7) the procedure for the removal of cells or tissues must avoid contamination of other donations and products, the processing environment and the staff.
Storage and release of products
§ 11 (1) for each type of storage conditions is to specify the maximum storage period. The selected period must take into account among other things the possible deterioration required cell and tissue characteristics.
(2) there must be an inventory system for tissues and cells, which will ensure that it not may be released for distribution, before fulfilling all requirements laid down in this regulation. SOPs must exist, which precisely define the conditions and the procedure for the release of cells or tissues for distribution. The release is in writing by the person responsible in accordance with § 9 GSG.
(3) at all stages of processing, a system for the identification of cells and tissues must be clearly shared products by non-shared (quarantined objects) and separate products are different.
(4) products must comply with the defined specifications prior to their release for distribution. Any deviation from the written specifications or laboratory controls, as well as any deviation from laboratory results are to investigate, establish and document in writing.
(5) from the documentary about the release shows that before cells or tissue are released, all requirements have been met under this regulation, that all current declaration forms, relevant medical records, processing records and results of laboratory inspections in accordance with a written procedure by the responsible person in accordance with § 9 have been reviewed GSG must.
(6) the person responsible in accordance with § must perform after the introduction of new donor selection or testing criterion or significantly modified processing 9 GSG a documented risk assessment with respect to the quality or safety of all already stored tissues and cells and with regard to its further use.
Critical transport conditions such as temperature and maximum duration are § 12 (1) to maintain the required tissue and cell properties to set.
(2) the container for the final packaging must be secure and ensure that quality of tissues and cells according to the specified conditions will be protected. The safety and practicality of all containers shall be validated.
(3) the transport is carried out by third parties, the tissue bank with these has concluded a written agreement to ensure that the necessary conditions are met.
(4) procedures for dealing with requests must be available to tissues and cells. The rules for allocation of tissues and cells from specific patients or health care facilities are to document and to provide them on request.
(5) it SPOs must exist for the handling of returned products, including, where appropriate, criteria for their resumption in the inventory.
Labelling for distribution
Section 13 (1) must bear the primary packaging for cells or tissues:
1. type of tissues and cells, unique identification code (ISBT 128) and, where appropriate, non - or batch number, 2. identification of the tissue establishment, 3. expiration date, 4. autologous donation: "only to the AUTOLOGOUS use", and specifying the donor/recipient, 5. the note "BIOHAZARD", if a product has resulted in a positive test result for an a relevant infectious disease marker known to be.
Can any of the information in accordance with Z 1 to 5 not on the primary packaging supplied, she shall on a separate sheet to specify, which inseparably attached is the primary packaging.
(2) the following information shall be either on the primary packaging or accompanying documents:
1. Description (definition) and, where appropriate, dimensions of the tissue or cell product, 2. If necessary, morphology and functional data, 3. date the tissue / cell distribution, 4. results of biological tests from the donor, 5. storage recommendations, 6 instructions to open the container, the packaging and any necessary handling / reconstitution, 7 expiration dates after opening / handling, 8 instructions for reporting serious adverse reactions or incidents in accordance with the Gewebevigilanzverordnung, Federal Law Gazette II No. 190/2008 , and 9 existence of potentially harmful residues.
(3) the primary packaging is in an outer packaging to transport, which must bear the following information:
1. the identification of the tissue establishment, including address and telephone number, 2. the identification of the responsible for the use of human determination organisation, including address and telephone number, 3. inscription "caution tissues and cells", 4. living cells are required for the transplant, is the inscription: "Do not IRRADIATE" ' add 5 recommended transport conditions, (E.g. "Keep cool", "UPRIGHT store"), and 6 safety instructions, where appropriate, cooling method.
Section 14 (1) within the tissue establishment must be responsible qualified personnel, to assess the need for a callback, to initiate the necessary measures and to coordinate.
(2) there must be an effective recall procedure, including a description of the responsibilities and the measures to be taken. GSG, including reporting to the Federal Office for security in the healthcare sector pursuant to article 17 paragraph 3.
(3) within predetermined periods, measures such as tracking and if necessary traceability of all relevant tissues and cells are to take. Through these measures, those donors are to determine, which may have contributed to causing the reaction in the receiver to identify available tissues and cells from these donors, as well as to inform industries agencies about the possible threat.
Referring to acts of the European Community
§ 15. This regulation will be
1. Directive 2006/86/EC of the Commission of 24 October 2006 on the implementation of Directive 2004/23/EC of the European Parliament and of the Council as regards requirements for the traceability, the message serious adverse events and adverse reactions, as well as certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, OJ No. L 294 of October 25, 2006 S 32, and 2. the directive 2006/17/EC of 8 February 2006 implementing 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. L 38 of February 9, 2006, p. 40, is implemented.