European Quality System for Tissue Banking

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! 1 " ! 1 " ! 1 8 #& , <0 8 + "# $ # 6 " %/ :% " %/ 9 : % 0 5 D <0230 #? = 2 D,+ # + $B 8 8%+ D# @% 8,+ "8 %",- ",&, %-% B # ,""# &-%+8 8 + $% $ % ?# %++ B 8%+ D# @% D ! !" "" • • •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he donor form shall contain the basic data for safety and quality of the donor screening and evaluation A uniform glossary is needed as all need to know exactly, what they are dealing with / 0 The donor evaluation is the most important quality and safety key point in the donation process Testing is the second most important quality and safety key point in the donation process. Both donor evaluation and testing should be at the same level in all the establishments participating in the project Selection of appropriate procurement methods, description of facilities, and trained personnel are the most important quality and safety key points Defining and setting up basic data for full traceability shall be mandatory 1 ) ( !") ! - ) !) )# / $ ))) ! ! ( $ '! () . Actions should include: review of the donor´s medical documentation, review of the donor´s history (personal, travel, social, behavioural etc), physical examination, blood samples collection, evaluation of the testing results, final decision-making about eligibility " 2 ! )' ! '! ( ! )) ) ( ) ) ( ' )) ) ( ) ) - '! )(! $ ( - ) () ) 0 ! ' 3 !! ( ' ( '! (# (4 ) - ) () (! ! # 5 )) ! # ! % ' !) ) 5 (( )) # ) ( ,! ! 3 ! " ) ,! " ( 6 ' ! ( ! )) ) 2 ( '! ( )) - " # ) "" ) $ ! ) " ! '! ( # !% 6 " ( ) ! ( )) -& '! ) !, ' (4 ) ! )) ) ( ) ) )) ! ( ( ) " # !% Transport conditions can influence the safety and quality of the tissue and cells therefore they shall be clearly defined and validated Tissues and cells received to TEs shall meet essential safety and quality criteria )' ! ! )' ! ) ! ' ! " )) )2( ) ++ # # , ! / 0 / 0 ) ! ) ! / 0 Although SOPs should be strictly individual for each TE depending on their premises and processing methods, the frame for the SOPs can be common. / 0 GTP manual should be useful )) ) ! '! ( )) ) For each donor, tissue/cell and tissue/cell product a unique identifier shall be assigned. Data on donors, tissue, distribution etc. shall be protected in order to prevent unauthorized disclosure, deletion or modification Processing environment shall assure that the final product will meet the predefined quality and safety criteria ++ - ) ! • • • ) '! ( () ! ) # '! -) ! ! (' )2 ! (' ) ) 7' ! 8 "' ! ' ! ) , !) 2! ( ! ' ! ' ( !! ( ( ) ! !* " !- ( 5 - ) - ) ( ) 6" 4 - ! , '& )# ) • • / 0 A uniform policy for establishment and management of witing lists is desirable. Priorities shall based on medical needs only There shall be assurance that only safe an high quality products are released for use Important key point for full traceability $ " 7' ! 6 "' ! )) ) '! ( )* • 8 ! " ( • 8 ! " #! ( • , ) - ( 6" 4 -& 3 ( ! '! ( & ! )' ) $ )& ( , ! ) -) !) # (# ( ) 0 - Exports-imports of tissues/cells and products only from facilities with the same or higher level of safety and quality ! ) ! ) ) "& ! )' ) $ ) " -& ! ! ' ! ' ! - !") !" ( !! ( , ( ) 0 SAE and SAR shall be reported to competent authorities and all partners. A system of tissue/cell vigilance should be established !! !) (( ) ' ! ' ( ) "& ! )' ) $ " -& ! !! !) (( )! ' ! ' ! - !") !! ( , ( ) • • • !! ( , ( ) )' ( ) ) !" ( ! ) )' ( ) ) $ ! (# ! - '! -! ") ! ) ) 2' !) ! 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"#$% ?% ,-%+ $ # ", +% 8 $ ?% % %/ / +%# 9 8 ?% ,- + D% 8% #6 ( & # ,-- & #6 " &, 7 6 8 -,+ D# @% %$ & %#$9 ,- # ( "8 %",5 & #" ++% F % 5 +#, 8 % &," + # & #6 " &, + :% " %/ %+ 5 $%+ % + %# 5 , $ % / + % , $9 ! 7 # && 1 : )) ! ; )< , !) , * any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells , !) ! ( * an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or transplantation of organs, tissues and cells (* Cells and tissues removed from one person and applied to another. - ) ' ( '! ( )) -* generally involves the sterilization of individual product components by sterilization methods such as filtration, steam, dry heat, ethylene oxide, or irradiation but not the tissue. The product components are then brought together under clean-room conditions. No final sterilization that sterilizes all product or package components is carried out. :: A documented review of procedures, records, personnel functions, equipment, materials, facilities, and/or vendors in order to evaluate adherence to written SOP´s, standards, or government laws and regulations. 1 $ ! $! ): Cells and tissues removed from and applied in the same person. : population of viable micro-organisms found on a given amount of material. : )* Individual cells of human origin or a collection of cells of human origin when not bound by any form of connective tissue. & ) ! Use of methods and techniques that keep microbial contamination of the tissues collected at a minimum level. 6! " (# - : as all the technical and procedural actions required to control microbial and particulate contamination in work areas, and maintain predetermined levels of contamination. ) * the actual costs for retrieval, processing, preservation, storage, distribution, education, ) research and development. ! ( means potentially have an effect on quality and/or safety of or having contact with the cells or tissues " ! ) $ : implant made from osseous tissue with a measurable residual below 5 % in its calcified intercellular calcium substances. !! " ) ( * a process reducing the number of viable microorganisms, but does not insure the complete destruction of microbial forms, such as spores and viruses. )!$ recipient. ! ( * transportation and delivery of tissues and cells for storage processing, or use in ) * means any procedure where cells are donated and used without any banking * donating human tissues and cells intended for human applications !* every human source, whether living or deceased, of human cells or tissues. ( !* any donor who has not undergone brain death. ( !6 , !6 ( ) !* any donor who has undergone brain death or cardiac death. ( ! ) !- ( ! ) )* any donor where organs, tissues or cells are collected during a surgical procedure where the material is removed for therapeutic purposes other than to obtain organs, tissues, or cells. ) !* facility, or medical practitioner who performs transplantation procedure : the date after which tissues or cells are no longer suitable for use 7' ! ! % 6 ! )) * achieved by freezing tissue in such a way that water is converted into ice in situ and subjected thereafter to a vacuum sufficient to facilitate sublimation of the ice thus formed. ) ! content is less than 6 % by gravimetric analysis. 5 ( * any area used in the procurement, processing, testing, storage or distribution of tissues/cells. 9 * Good Manufacturing Practice is a quality assurance scheme, which ensures that medicinal products are consistently produced and controlled to quality standards. #$ % & ' ( ! ! )' " ! : the result of a series of operations including collection, processing, testing and package, ready to be delivered and used by the medical practitioner. = !": physical injury and/or damage to health and property. ) * ' !+ , / , 0 11/ , , -' . " = % ! : potential source of harm. ) * ' !+ , 11/ , , -' . " - ' . / -' . , 0 + $ : A display of written, printed, or graphic matter upon the immediate container of any article. # 2 ' 2' ' 3 2 - 2 ' 2'4 9 ( ( ( : person licensed by a country to practice the healing arts within its jurisdiction . -: the physical contact or mixing of cells or tissues from two or more donors in a single container. ! ) !, : the proper combination of conditions that preserve the quality of tissues during specified storage periods. ! : a series of technical steps precisely followed in a defined order. ! ( ! ( )) -: means all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications ! ( ! " * means a process by which tissues or cells are made available. : The conformance of a tissue or process with pre-established specifications or Standards. ' )) ! ( : all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. )) ! ( * activities to assure and verify confidence in the quality of the process used for the finished tissue and which document that the entire operation (e.g., facilities, personnel, methods, practices, and research) is in conformity with the standards of tissue banking. ' ( ! * the operational techniques and activities that are used to fulfil requirements for quality. " ( ! * specific tests defined by the Quality Assurance Program to be performed to monitor retrieval, processing, preservation and storage, tissue quality, and test accuracy. These may include but are not limited to: performance evaluation, testing, and controls used to determine the accuracy and reliability of the tissue bank´s equipment and operational procedures as well as ' ) the monitoring of supplies, reagents, equipment, and facilities. ! : status of retrieved tissue or cells, or tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection. (' : the person into whom an organ, tissue or cells is/are grafted/implanted. "$ !) " : a payment of money equal to, but not exceeding, expenses necessarily incurred. " ) ! : the ration of the mass of residual water to the mass of lyophilizate. ) ! , : the procurement, harvesting or collection of transplantable tissues or cells, whether viable or not, from a living or non-living donor, for the benefit of one or more patients. )4: the probability of a hazard causing harm and the degree of severity of the harm. ) * ' !+ , - ' . / , 0 11/ , , ' . " )4 ) ): investigation of available information to identify hazards and estimate risk. ) * ' !+ , - ' . / , 0 11/ , , -' . " " , "' ! ! * * freedom from unacceptable risk of harm. ) * ' 0 11/ , , -' . !+ " , - ' . / ! ) , !) , any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening disabling, or incapacitation conditions for patients or which results in, or prolongs, hospitalisation or morbidity. ! ) , !) ! ( ’ means an unintended response,including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs,hospitalisation or morbidity; ! )* specifications, requirements and procedures applicable to donor screening, tissue procurement, testing, processing, storage and distribution designed to ensure the continued purity, potency, clinical efficacy and safety of such tissues during the dating period. ! ' ! ! ( ! ); )<* means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product. ! ) * a physical or chemical process validated to destroy, inactivate or reduce microorganisms to a sterility assurance level of 10 -6. ! - * maintaining the product under appropriate controlled conditions until distribution. !- ( ! ) )* means collection of tissues/cells during a surgical procedure where the material is removed for therapeutic purposes other than to obtain organs, tissues, or cells. )) * human tissue includes all constituted parts of a human body formed by cells including surgical residues and amnion, but excluding organs, blood and blood products. New products engineered from human tissue are included. )) ) $ )#" means a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells !* wrapping system insuring the integrity and sterility of tissues. )) ( )) ' (4 - * additional wrapping used to protect one or more tissue containers during transit. ! ( $ * the ability to locate the tissue during any step between its donation, collection, processing, testing, storage and distribution. It implies the capacity to identify the donor and the medical facility receiving the tissue, and at the medical facility, the ability to identify the recipient. 0 ; ! 3 ( in the case of equipment or environments)* means establishing documented evidence, that provides a high degree of assurance, that a specific process, SOP, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use. !( )* 2004/23/EC * ! ( , # ! ' ! " # 1 CoE 2004* ( >??@2>A2 < 5 6 - 5 * 7! / 1 -- " -- 1- * 1- -/ 8 : ! !" 7 "' ; ( 5# (# !"* B ' B 1 B B< : 1 >??A 1 > >AA ! ! ( )) ) 6 ) Written instructions of Standard Operating Procedures (SOPs) shall be produced where it is essential that tasks be performed in a consistent way. Equipment, processes and procedures shall be validated as effective before being implemented or changed. Equipment essential to the quality of the product shall be routinely serviced and calibrated if appropriate. The processing environment and staff performing processes shall meet prescribed standards of cleanliness. The Tissue Bank shall maintain a SOP Manual which details in writing all aspects of donor screening, retrieval, processing, testing, storage, and distribution practices. The SOPs shall be utilised to ensure that all material released for transplantation meet at least requirements defined by professional standards and applicable Inter-governmental, National, Regional and Local Law or Regulation. The SOP manuals should include, where relevant, but should not be limited to the following: - Standard procedures for donor screening, consent, retrieval, processing, preservation, testing, storage and distribution. - Quality Assurance and quality control policies. - Laboratory procedures for tests performed in-house and in contracted laboratories. - Specifications for materials used including supply, reagents, storage media, packaging materials. - Personnel and facility safety procedures. - Standard procedures for facilities maintenance, cleaning and waste disposal procedures. - Methods for verification of the effectiveness of sterilisation procedures. - Equipment maintenance, calibration and validation procedures. - Environmental and microbiological conditions and the methods used for controlling, testing and verification. - Physiological and physical test specifications for materials. - Methods for determination of shelf life, storage temperature, and assigning expiry dates of tissues and cells. - Determination of inserts and or label text. - Policies and procedures for exceptional release of material. - Procedures for adverse events reporting and corrective actions. - Donor/recipient tracking and product recall policies and procedures. All SOPs and associated process-validation studies shall be reviewed and approved by either the Medical or Administrative Director as dictated by content. All medically related SOPs shall be reviewed and approved by the Medical Director. Copies of the Procedure Manual shall be available to all staff, and to authorised individuals for inspections upon request. Upon implementation, all SOPs shall be followed as written. SOPs shall be updated at regular intervals to reflect modifications or changes. The authorised person, depending on the content shall approve each modification. Appropriate training shall be provided to pertinent staff. Obsolete Procedural Manuals shall be archived for a minimum of 10 years taking into account the shelf life of the material. > >A? > >A. ! , ( ) ) ! ! , Procurement shall be accomplished in an operating room or adequate mortuary facility. > >A> ! ( ! " 3 '" ! All instruments and equipment used for procurement shall be sterilised between procurements or, whenever possible single-use instruments shall be used. > >AA ) ' ( ! & ! (# 3 ) Tissues may be removed using either aseptic or clean, non sterile techniques: Aseptic procurement: Aseptic technique shall be observed throughout the procurement procedure. Procurement sites shall be prepared using a standard surgical prep, all methods shall be consistent with standard operating room practice. Clean non sterile technique: Allografts procured using clean, non-sterile techniques are suitable for transplantation if efficient validated sterilising methods are used to eliminate pathogens after retrieval. > >A@ "' ) ! 9 (! $ -( ) - Samples for microbiological testing shall be taken where applicable. : 0 1 >??A 1 > >AC ( ! ' - Records shall be confidential, accurate, complete, legible and indelible. All donor, processing, storage, and distribution records should be maintained for 30 years or in accordance with applicable Inter-governmental, National, Regional and Local Law or Regulation. Records shall hold all information that identifies the origins of the product and to demonstrate that the product meets all the quality requirements. Records shall show that all the required processing steps and all Quality Control tests have been performed correctly by trained staff and that the product has only been released for use after the correct authorisation. Records shall also demonstrate correct handling and storage of materials and track the final fate of products, whether transplanted, discarded or used for research. The use and storage of records shall be controlled. / When two or more Tissue Banks participate in tissue procurement, processing, storage, or distribution functions, the relationships and responsibilities of each shall be documented and ensure compliance with with relevant scientific and quality standards by all parties. Tissue Banks should perform on-site audits of contract laboratories to ensure their compliance with professional Standards and Technical Manuals and the Tissue Bank’s own requirements. ) . 5" A record of unprocessed, processed, quarantined and distributed tissues shall be maintained. / 1 . . 9 0 1- " An adverse events file shall be maintained including any non-compliances. / If a computer record-keeping system is used, there shall be a system to ensure the authenticity, integrity and confidentiality of all records but retain the ability to generate true paper copies. A description of the system, its function and specified requirements must be documented. The system shall record and identity of persons entering or confirming critical data. Alteration to the system or Programme shall only be made in accordance with defined procedures. When the release of finished batches for storage or issue is conducted by computerised systems it must identify and record the person (s) releasing the batches. Alternative management systems should be available to cope with failures in computerised systems. :0 >??A2.D2 > ( ' # )) 2( ) # )) ) $ )#" 2.1. When the retrieved tissues/cells arrive at the tissue establishment, there must be documented verification that the consignment, including the transport conditions, packaging, labelling and associated documentation and samples, meet the requirements of this Annex and the specifications of the receiving establishment. 2.2. Each establishment must ensure that the tissue and cells received are quarantined until they, along with the associated documentation, have been inspected or otherwise verified as conforming to requirements. The review of relevant donor/procurement information and thus acceptance of the donation needs to be carried out by specified/authorised persons. 2.3. Each tissue establishment must have a documented policy and specifications against which each consignment of tissues and cells, including samples, are verified. These must include the technical requirements and other criteria considered by the tissue establishment to be essential for the maintenance of acceptable quality. The tissue establishment must have documented procedures for the management and segregation of non-conforming consignments, or those with incomplete test results, to ensure that there is no risk of contamination of other tissues and cells being processed, preserved or stored. 2.4. The data that must be registered at the tissue establishment (except for donors of reproductive cells intended for partner donation) include: (a) consent/authorisation; including the purpose(s) for which the tissues and cells may be used (i.e. therapeutic or research, or both therapeutic use and research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained; (b) all required records relating to the procurement and the taking of the donor history, as described in the donor documentation section; (c) results of physical examination, of laboratory tests and of other tests (such as the autopsy report, if used in accordance with point 1.2.2.); (d) for allogeneic donors, a properly documented review of the complete donor evaluation against the selection criteria by an authorised and trained person; (e) in the case of cell cultures intended for autologous use, documentation of the possibility of medicinal allergies (such as to antibiotics) of the recipient. 2.5. In the case of reproductive cells intended for partner donation, the data to be registered at the tissue establishment include: (a) consent; including the purpose(s) for which the tissues and cells may be used (such as reproductive only and/or for research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained; (b) donor identification and characteristics: type of donor, age, sex, presence of risk factors and, in the case of a deceased donor, the cause of death; (c) partner identification; (d) place of procurement; (e) tissues and cells obtained and relevant characteristics. :0 >??E2.D2 & !" 70 ( # ! ' - ) " (a) Donation identification: CUnique ID number CIdentification of the Tissue establishment (b) Product identification: CProduct code (basic Nomenclature) CSplit number (if applicable) CExpiry date :0 ! ( .@& >??@2>A2 '! ( ( 1. Member States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive and to which third parties have access, have been rendered anonymous so that neither donors nor recipients remain identifiable. 2. For that purpose, they shall ensure that: (a) data security measures are in place, as well as safeguards against any unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information; (b) procedures are in place to resolve data discrepancies; and (c) no unauthorised disclosure of information occurs, whilst guaranteeing the traceability of donations. 3. Member States shall take all necessary measures to ensure that the identity of the recipient(s) is not disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions for disclosure, notably in the case of gametes donation. :0 >??@2772 7 & + 2 9 1. A tissue establishment must have suitable facilities to carry out the activities for which accreditation / designation / authorisation or licensing is sought, in accordance with the standards laid down in this Directive. 2. When these activities include processing of tissues and cells while exposed to the environment, this must take place in an environment with specified air quality and cleanliness in order to minimise the risk of contamination, including crosscontamination between donations. The effectiveness of these measures must be validated and monitored. 3. Unless otherwise specified in point 4, where tissues or cells are exposed to the environment during processing, without a subsequent microbial inactivation process, an air quality with particle counts and microbial colony counts equivalent to those of Grade A as defined in the current European Guide to Good Manufacturing Praktice (GMP), Annex 1 Commission Directive 2003/94/EC7 is required with a background environment appropriate for the processing of the tissue/cell concerned but at least equivalent to MP Grade D in terms of particles and microbial counts. 4. A less stringent environment than specified in point 3 may be acceptable where: (a) a validated microbial inactivation or validated terminal sterilisation process is applied; (b) or, where it is demonstrated that exposure in a Grade A environment has a detrimental effect on the required properties of the tissue or cell concerned; (c) or, where it is demonstrated that the mode and route of application of the tissue or cell to the recipient implies a significantly lower risk of transmitting bacterial or fungal infection to the recipient than with cell and tissue transplantation; (d) or, where it is not technically possible to carry out the required process in a Grade A environment (for example, due to requirements for specific equipment in the processing area that is not fully compatible with Grade A). 5. In point 4 (a), (b), (c) and (d), an environment must be specified. It must be demonstrated and documented that the chosen environment achieves the quality and safety required, at least taking into account the intended purpose, mode of application, immune status of the recipient. Appropriate garments and equipment for personal protection and hygiene must be provided in each relevant department of the tissue establishment along with written hygiene and gowning instructions. 6. When the activities for which accreditation / designation / authorisation or licensing is sought involve storage of tissues and cells, the storage conditions necessary to maintain the required tissue and cell properties, including relevant parameters such as temperature, humidity or air quality must be defined. 7. Critical parameters (e.g. temperature, humidity, air quality) must be controlled, monitored, and recorded to demonstrate compliance with the specified storage conditions. 8. Storage facilities must be provided that clearly separate and distinguish tissues and cells prior to release/in quarantine from those that are released and from those that are rejected, in order to prevent mix-up and cross-contamination between them. Physically separate areas or storage devices or secured segregation within the device must be allocated in both quarantine and released storage locations for holding certain tissue and cells collected in compliance with special criteria. 9. The tissue establishment must have written policies and procedures for controlled access, cleaning and maintenance, waste disposal and for the re-provision of services in an emergency situation. : : >??@2772 ! 1 When the activities for which the accreditation / designation / authorisation / licensing is sought include processing of tissues and cells, the tissue establishment procedures must comply with the following criteria: 1. The critical processing procedures must be validated and must not render the tissues or cells clinically ineffective or harmful to the recipient. This validation may be based on studies performed by the establishment itself, or on data from Publisher studies or, for well established processing procedures, by retrospective evaluation of the clinical results for tissues supplied by the establishment. 2. It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff, 3. The procedures must be documented in SOPs which must conform to the validated method and to the standards laid down in this Directive, accordingly with Annex I E points .1.to 4. 4. It must be ensured that all processes are conducted in accordance with the approved SOPs. 5 Where a microbial inactivation procedure is applied to the tissue or cells, it must be specified, documented, and validated. 6. Before implementing any significant change in processing, the modified process must be validated and documented. 7. The processing procedures must undergo regular critical evaluation to ensure that they continue to achieve the intended results. 8. Procedures for discarding tissue and cells must prevent the contamination of other donations and products, the processing environment or personnel. These procedures must comply with national regulations. + When the activities for which the accreditation / designation / authorisation / licensing is sought include storage and release of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria: 1. Maximum storage time must be specified for each type of storage condition. The selected period must reflect among others possible deterioration of the required tissue and cell properties. 2. There must be a system of inventory hold for tissues and/or cells to ensure that they cannot be released until all requirements laid down in this Directive have been satisfied. There must be a standard operating procedure that details the circumstances, responsibilities and procedures for the release of tissues and cells for distribution. 3. A system for identification of tissues and cells throughout any phase of processing in the tissue establishment must clearly distinguish released from non-released (quarantined) and discarded products 4. Records must demonstrate that before tissues and cells are released all appropriate specifications are met, in particular all current declaration forms, relevant medical records, processing records and test results have been verified according to a written procedure by a person authorised for this task by the responsible person as specified in Article 17 of Directive 2004/23/EC. If a computer is used to release results from the laboratory, an audit trail should indicate who was responsible for their release. 5. A documented risk assessment approved by the responsible person as defined in Article 17of Directive 2004 must be undertaken to determine the fate of all stored tissues and cells following the introduction of any new donor selection or testing criterion or any significantly modified processing step that enhances safety or quality. 1 ++ When the activities for which the accreditation / designation / authorisation / licensing is sought include distribution of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria: 1 1. Critical transport conditions, such as temperature and time limit must be defined to maintain the required tissue and cell properties. 2. The container/ package must be secure and ensure that the tissue and cells are maintained in the specified conditions. All containers and packages need to be validated as fit for purpose. 3. Where distribution is carried out by a contracted third party, a documented agreement must be in place to ensure that the required conditions are maintained. 4. There must be personnel authorised within the tissue establishment to assess the need for recall and to initiate and coordinate the necessary actions. 5. An effective recall procedure must be in place, including a description of the responsibilities and actions to be taken. This must include notification to the competent authority. 6. Actions must be taken within pre-defined periods of time and must include tracing all relevant tissues and cells and, where applicable, must include trace-back. The purpose of the investigation is to identify any donor who might have contributed to causing the reaction in the recipient and to retrieve available tissues and cells from that donor, as well as to notify consignees and recipients of tissues and cells procured from the same donor in the event that they might have been put at risk. 7. Procedures must be in place for the handling of requests for tissues and cells. The rules for allocation of tissues and cells to certain patients or health care institutions must be documented and made available to these parties upon request. 8. A documented system must be in place for the handling of returned products including criteria for their acceptance into the inventory, if applicable. + + 1 ++ 1 1. The primary tissue/cell container must provide : a) Type of tissues and cells, identification number or code of the tissue /cells, and lot or batch number where applicable; b) Identification of the tissue establishment c) Expiry date d) In the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified. e) In the case of directed donations - the label must identify the intended recipient f) when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARD; If any of the information under points (d) to (e) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container. This sheet must be packaged with the primary container in a manner that ensures that they remain together. 2. The following information must be provided either on the label or in accompanying documentation: a) Description (definition) and, if relevant, dimensions of the tissue or cell product; b) Morphology and functional data where relevant c) Date of distribution of the tissue /cells; d) Biological determinations carried out on the donor and results; e) Storage recommendations; f) Instructions for opening the container, package, and any required manipulation / reconstitution; g) Expiry dates after opening /manipulation; h) Instructions for reporting serious adverse reactions and /or events as set out in Articles 5 to 6. i) Presence of potential harmful residues (e.g. Antibiotics, ethylene oxide etc) : + + 1 ++ = = For transport, the primary container must be placed in a shipping container that must be labelled with at least the following information: a) Identification of the originating tissue establishment, including an address and phone number; b) Identification of the organisation responsible for human application of destination, including address and phone number; c) A statement that the package contains human tissue/cells and HANDLE WITH CARE; d) Where living cells are required for the function of the graft, such as stem cells gametes and embryos, the following must be added: ‘DO NOT IRRADIATE’; e) Recommended transport conditions (e.g. keep cool, in upright position, etc.); f) Safety instructions / method of cooling (when applicable). :: >??@2772 & 7 + When the activities for which the accreditation / designation / authorisation / licensing is sought include storage and release of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria: 1. Maximum storage time must be specified for each type of storage condition. The selected period must reflect among others possible deterioration of the required tissue and cell properties. 2. There must be a system of inventory hold for tissues and/or cells to ensure that they cannot be released until all requirements laid down in this Directive have been satisfied. There must be a standard operating procedure that details the circumstances, responsibilities and procedures for the release of tissues and cells for distribution. 3. A system for identification of tissues and cells throughout any phase of processing in the tissue establishment must clearly distinguish released from non-released (quarantined) and discarded products 4. Records must demonstrate that before tissues and cells are released all appropriate specifications are met, in particular all current declaration forms, relevant medical records, processing records and test results have been verified according to a written procedure by a person authorised for this task by the responsible person as specified in Article 17 of Directive 2004/23/EC. If a computer is used to release results from the laboratory, an audit trail should indicate who was responsible for their release. 5. A documented risk assessment approved by the responsible person as defined in Article 17of Directive 2004 must be undertaken to determine the fate of all stored tissues and cells following the introduction of any new donor selection or trstiny criterion or any significantly modified processing step that enhances safety or quality. :: ' !" = # ! ( ( ! )) 1 4) >??. (attached as a .pdf file: Annex J) :: >??@2>A2 & ! ( F "' ! 2 7' ! # " )) ) ( ) " 1. Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive. 2. Member States shall take all necessary measures to ensure that all exports of tissues and cells to third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities. Those Member States that send such exports to third countries shall ensure that the exports comply with the requirements of this Directive. 3. (a) The import or export of tissues and cells referred to in Article 6(5) may be authorised directly by the competent authority or authorities. (b) In case of emergency, the import or export of certain tissues and cells may be authorised directly by the competent authority or authorities. (c) The competent authority or authorities shall take all necessary measures to ensure that imports and exports of tissues and cells referred to in subparagraphs (a) and (b) meet quality and safety standards equivalent to those laid down in this Directive. 4. The procedures for verifying the equivalent standards of quality and safety in accordance with paragraph 1 shall be established by the Commission, in accordance with the procedure referred to in Article 29(2). :: >??E2772 ( & ! ( C ) ! ) , !) ! ( ) 1. Member States shall ensure that: (a) procurement organisations have procedures in place to retain the records of tissues and cells procured and to notify tissue establishments without delay of any serious adverse reactions in the living donor which may influence the quality and safety of tissues and cells; (b) organisations responsible for human application of tissues and cells have procedures in place to retain the records of tissues and cells applied and to notify tissue establishments without delay of any serious adverse reactions observed during and after clinical application which may be linked to the quality and safety of tissues and cells; (c) tissue establishments that distribute tissue and cells for human application provide information to the organisation responsible for human application of tissues and cells about how that organisation should report serious adverse reactions as referred to in (b). 2. Member States shall ensure that tissue establishments: (a) have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse reactions as referred to in paragraph 1 (a) and (b); (b) have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome. 3. Member States shall ensure that (a) the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority the information included in the notification set out in Part A of Annex III; (b) tissue establishments notify the competent authorities of the actions taken with respect to other implicated tissues and cells that have been distributed for human applications; (c) tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex III. ! ( E ( ) ! ) , !) , ) 1. Member States shall ensure that: (a) Procurement organisations and tissue establishments have procedures in place to retain the records to notify tissue establishments without delay of any serious adverse events that occur during procurement which may influence the quality and/or safety of human tissues and cells. (b) organisations responsible for human application of tissues and cells have procedures in place to notify tissue establishments without delay of any serious adverse events that may influence the quality and safety of the tissues and cells" (c) tissue establishments provide to the organisation responsible for human application information about how that organisation should report serious adverse events to them that may influence the quality and safety of the tissues and cells. 2. In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up shall be considered to be a serious adverse event. All persons or procurement organisations or organisations responsible for human application)performing assisted reproduction shall report such events to the supplying tissue establishments for investigation and notification to the competent authority 3. Member States shall ensure that tissue establishments: (a) have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse events as referred to in paragraph 1 (a) and (b); (b) have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome 4. Member States shall ensure that: (a) the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority the Information included in the notification set out tin Part A of Annex IV; (b) tissue establishments evaluate serious adverse events to identify preventable causes within the process; (c) tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex IV. :: 0 >??@2>A2 )' ( & ! ( D ) ( ! " ) ! ) 1. Member States shall ensure that the competent authority or authorities organise inspections and that tissue establishments carry out appropriate control measures in order to ensure compliance with the requirements of this Directive. L 102/52 EN Official Journal of the European Union 7.4.2004 2. Member States shall also ensure that appropriate control measures are in place for the procurement of human tissues and cells. 3. Inspections shall be organised and control measures shall be carried out by the competent authority or authorities on a regular basis. The interval between two inspections shall not exceed two years. 4. Such inspections and control measures shall be carried out by officials representing the competent authority, who shall be empowered to: (a) inspect tissue establishments and the facilities of any third parties as specified in Article 24; (b) evaluate and verify the procedures and the activities carried out in tissue establishments and the facilities of third parties that are relevant to the requirements of this Directive; (c) examine any documents or other records relating to the requirements of this Directive. 5. Guidelines concerning the conditions of the inspections and control measures, and on the training and qualification of the officials involved in order to reach a consistent level of competence and performance, shall be established in accordance with the procedure referred to in Article 29(2). 6. The competent authority or authorities shall organize inspections and carry out control measures as appropriate whenever there is any serious adverse reaction or serious adverse event. In addition, such an inspection shall be organized and control measures shall be carried out at the duly justified request of the competent authority or authorities in another Member State in any such case. 7. Member States shall, upon the request of another Member State or the Commission, provide information on the results of inspections and control measures carried out in relation to the requirements of this Directive. : :0 >??@& > C.> 7 :0 )) ))" & ! 7 ! Auditing is an essential tool and should be conducted in an independent way by designated trained and competent persons. It may be performed in different ways including self assessment, internal and external audits. Self assessment is a method of an organisations own personnel reviewing each step in a process in which they are involved to ensure ongoing improvement. Internal audit is performed by the organisations quality personnel. External audit is performed by independent bodies, often designated approved/competent authorities, and are often required for accreditation and licensing purposes. All audits should be documented and recorded. Clear procedures need to be in place to ensure that appropriate suggested corrective actions are taken. These actions and their completion should be recorded. A culture should exist within an organisation to promote the open reporting of errors and incidents and thus encourage the consequent improvements in practice that investigations of such events can bring. Where changes to standard operating procedures are made these should be made under strict change control mechanisms. : :0 >??E2772 1 & 7 + 1. The personnel in tissue establishments must be available in sufficient number and be qualified for the tasks they perform. The competency of the personnel must be evaluated at appropriate intervals specified in the quality system. 2. All personnel should have clear, documented and up-to-date job descriptions. Their tasks, responsibilities and accountability must be clearly documented and understood. 3. Personnel must be provided with initial/basic training, updated training as required when procedures change or scientific knowledge develops and adequate opportunities for relevant professional development. 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