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17 May 2011

New Annex 14: Consequences for QPs

The European Commission has revised Annex 14 of the EU-GMP Guide, defining requirements for drugs derived from human blood or plasma. The new Annex 14 also applies to stable derivatives of human blood or human plasma (e.g. albumin) incorporated into medical devices. However it does not apply to blood components intended for transfusion.

The revision became necessary to implement contents of respective Directives like for example 2002/98/EC which define requirements for the collection and testing of human blood and blood components.

The new Annex 14 introduces some revised and new requirements for Qualified Persons of the respective establishments:

Steps like processing, storage and transportation which are done after the collection should be performed in an establishment with a manufacturing authorisation under the responsibility of a Qualified Person.

However the new Annex takes into account the fact that specific processing steps in relation to plasma for fractionation take place in a blood establishment without a manufacturing authorisation. Here the specific appointment of a qualified person may not be proportionate. These steps should be than be carried out under the responsibility of a responsible person. In this case, a contract is needed which clearly defines the responsibilities and requirements in order to ensure quality and safety. The Qualified Person than should ensure that audits are performed to confirm that the blood establishment complies with the contract and the requirements.

The deadline for coming into operation of the new Annex is 30 November 2011.

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