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Commission Directive 2006/86/ECShow full title

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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C.STORAGE AND RELEASE OF PRODUCTSU.K.+E.U.

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 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.

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