At a recent TADG there was some discussion that staff completing/ submitting the annual BCR don't always have access to SLA's (Contracts) that are in place and that they donít get to see the SLA for annual review and to ensure these comply with the GPG. Individuals signing off the BCR without having sight of these documents may unwittingly leave themselves open to a non-conformance, especially if they have been told they cannot see them.

Please see relevant references below:

1.2.2. The Quality System encompasses quality management, quality assurance, continuous quality
improvement, personnel, premises and equipment, documentation, collection, testing and
processing, storage, distribution, quality control, blood component recall, and external and
internal auditing, contract management, non-conformance and self-inspection (Directive
2005/62/EC/Annex 1.1.2).

1.2.17. A product quality review may also be considered as an instrument for surveying the overall
quality status of a blood component and its manufacturing processes, including the collection.
Such a review should normally be conducted annually and should be documented. It may
include:

1.2.17.6. review of technical agreements and contracts;

In addition please see Section 8 of the GPG.

For any further info- please contract Mike Dawe at MHRA : Michael.Dawe@mhra.gov.uk

Many thanks.