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Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)
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has demonstrated competence in the performance of their designated tasks;
has an adequate knowledge and understanding of the scientific/technical processes and principles relevant to their designated tasks;
understands the organisational framework, quality system and health and safety rules of the establishment in which they work, and
is adequately informed of the broader ethical, legal and regulatory context of their work.
a validated microbial inactivation or validated terminal sterilisation process is applied;
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;
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;
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).
The competent authority shall authorise each tissue and cell preparation process after evaluation of the donor selection criteria and procurement procedures, the protocols for each step of the process, the quality management criteria, and the final quantitative and qualitative criteria for cells and tissues. This evaluation must comply at least with the requirements set out in this Annex.
Upon reception of procured tissues and cells at the tissue establishment, the tissues and cells must comply with the requirements defined in Directive 2006/17/EC.
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:
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 published studies or, for well established processing procedures, by retrospective evaluation of the clinical results for tissues supplied by the establishment.
It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff.
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.
It must be ensured that all processes are conducted in accordance with the approved SOPs.
Where a microbial inactivation procedure is applied to the tissue or cells, it must be specified, documented, and validated.
Before implementing any significant change in processing, the modified process must be validated and documented.
The processing procedures must undergo regular critical evaluation to ensure that they continue to achieve the intended results.
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:
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.
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.
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.
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.
A documented risk assessment approved by the responsible person as defined in Article 17 of Directive 2004/23/EC 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.
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:
Critical transport conditions, such as temperature and time limit must be defined to maintain the required tissue and cell properties.
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.
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.
There must be personnel authorised within the tissue establishment to assess the need for recall and to initiate and coordinate the necessary actions.
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.
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.
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.
A documented system must be in place for the handling of returned products including criteria for their acceptance into the inventory, if applicable.
type of tissues and cells, identification number or code of the tissue/cells, and lot or batch number where applicable;
identification of the tissue establishment;
expiry date;
in the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified;
in the case of directed donations - the label must identify the intended recipient;
when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARD[F1;]
[F2Single European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application.]
Textual Amendments
[F1If any of the information under points (d), (e) and (g) 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.]
description (definition) and, if relevant, dimensions of the tissue or cell product;
morphology and functional data where relevant;
date of distribution of the tissue/cells;
biological determinations carried out on the donor and results;
storage recommendations;
instructions for opening the container, package, and any required manipulation/reconstitution;
expiry dates after opening/manipulation;
instructions for reporting serious adverse reactions and/or events as set out in Articles 5 to 6;
presence of potential harmful residues (e.g. antibiotics, ethylene oxide etc)[F1;]
[F2for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country).]
For transport, the primary container must be placed in a shipping container that must be labelled with at least the following information:
identification of the originating tissue establishment, including an address and phone number;
identification of the organisation responsible for human application of destination, including address and phone number;
a statement that the package contains human tissue/cells and HANDLE WITH CARE;
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’;
recommended transport conditions (e.g. keep cool, in upright position, etc.);
safety instructions/method of cooling (when applicable).
Tissue establishment
EU tissue establishment code (if applicable)
Report identification
Reporting date (year/month/day)
Individual affected (recipient or donor)
Date and place of procurement or human application (year/month/day)
Unique donation identification number
Date of suspected serious adverse reaction (year/month/day)
Type of tissues and cells involved in the suspected serious adverse reaction
Single European Code of tissues or cells involved in the suspected serious adverse reaction (if applicable)
Type of suspected serious adverse reaction(s)
Tissue establishment
EU tissue establishment code (if applicable)
Report identification
Confirmation date (year/month/day)
Date of serious adverse reaction (year/month/day)
Unique donation identification number
Confirmation of serious adverse reaction (Yes/No)
Single European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)
Change of type of serious adverse reaction (Yes/No) If YES, specify
Clinical outcome (if known)
Complete recovery
Minor sequelae
Serious sequelae
Death
Outcome of the investigation and final conclusions
Recommendations for preventive and corrective actions
Tissue establishment | ||||
EU tissue establishment code (if applicable) | ||||
Report identification | ||||
Reporting date (year/month/day) | ||||
Date of serious adverse event (year/month/day) | ||||
Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in: | Specification | |||
---|---|---|---|---|
Tissues and cells defect | Equipment failure | Human error | Other (specify) | |
Procurement | ||||
Testing | ||||
Transport | ||||
Processing | ||||
Storage | ||||
Distribution | ||||
Materials | ||||
Others (specify) |
Tissue establishment
EU tissue establishment code (if applicable)
Report identification
Confirmation date (year/month/day)
Date of serious adverse event (year/month/day)
Root cause analysis (details)
Corrective measures taken (details)]
Identification of the procurement organisation (including contact details) or the tissue establishment
Unique donation number
Date of procurement
Place of procurement
Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)
Identification of the tissue establishment
Type of tissue and cell/product (basic nomenclature)
Pool number (in case of pooling)
Split number (if applicable)
Expiry date (if applicable)
Tissue/cell status (i.e. quarantined, suitable for use, etc.)
Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety.
Identification of the facility issuing the final label
Date of distribution/disposal
Identification of the clinician or end-user/facility
DONATION IDENTIFICATION SEQUENCE | PRODUCT IDENTIFICATION SEQUENCE | |||||
EU TISSUE ESTABLISHMENT CODE | UNIQUE DONATION NUMBER | PRODUCT CODE | SPLIT NUMBER | EXPIRY DATE (YYYYMMDD) | ||
ISO country code | Tissue establishment number | Product Coding System identifier | Product number | |||
2 alphabetic characters | 6 alpha-numeric characters | 13 alpha-numeric characters | 1 alphabetic character | 7 alpha-numeric characters | 3 alpha-numeric characters | 8 numeric characters] |
OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
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