Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.6.1. GENERAL

1. When the activities for which the accreditation/ designation/ authorisation/ licensing is sought include storage and release of tissues and cells, the authorised TE procedures must comply with the following criteria:

a)   Maximum storage time must be specified for each type of storage condition. The selected period must, among other things, reflect possible deterioration of the required tissue and cell properties.

b)   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.

c)   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.

d)   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.  If a computer is used to release results from the laboratory, an audit trail should indicate who was responsible for their release.

e)   A documented risk assessment approved by the responsible person 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]

2. TE shall ensure that all procedures associated with the storage of tissues and cells are documented in the standard operating procedures and that the storage conditions comply with the requirements referred to in this text.

3. TE shall ensure that all storage processes are carried out under controlled conditions.

4. TE shall establish and apply procedures for the control of packaging and storage areas, in order to prevent any situation arising that might adversely affect the functioning or integrity of tissues and cells.

5. Tissues shall not be distributed until all the requirements laid down in Directive 2004/23/EC have been met[2].

6. Each tissue bank should establish validated temperature-range limits and storage times for each tissue product, depending on its processing, packaging and intended use.

7. All human tissue prior to determination of suitability must be under Quarantine. Quarantined tissues should be physically separated and visibly different from released tissues, by labelling or packaging.  Where a donor sample tests positive or reactive for an infectious marker, the tissue should immediately be removed from the quarantine inventory.

 

8. Where quarantined tissue is shipped for processing or storage, it should be accompanied by records ensuring identification of the donor and indicating that the tissue has not been determined suitable for transplantation.  Tissue determined to be unsuitable for transplantation and intended for release for other purposes should be identified accordingly.

 

9. Quarantine records for tissue quarantined post-release should indicate the reason for quarantine and the final disposition of the tissue.  Release dates or disposal dates should be indicated as well.

 

10. Policies and procedures should be developed for the emergency transfer of tissue to designated alternative storage facilities, and for alternative monitoring methods, in the event of mechanical failure or loss of coolant.  These should include specification of Tolerance Limits or temperatures and time limits after which the initiation of the emergency transfer is required.  Actions to be taken when limits have been exceeded should also be specified in the relevant SOP.



[1] Commission Directive 2006/86/EC (Annex II)

[2] Directive 2004/23/EC of the European Parliamenr and of the Council ( Art. 21)

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