Proposed EU GMP Annex 16 update
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The deadline for public comments on the concept paper on revising EU GMP Annex 16 – Certification by a Qualified Person and batch release is due in just a few weeks. Closing date is 31st January 2012.Problem statements (from the concept paper)
- What is the minimum a Qualified Person (QP) must personally carry out when certifying a batch?
- What are the prerequisites for relying on statements from persons other than fellow QPs?
- How is the Control Strategy and the batch certification release process linked?
- What are the expectations for QPs reviewing batch records manufactured by third parties in third countries?
- What knowledge should a QP have about the site(s) involved in the manufacturing of a batch?
- What actions are expected from the QP when a batch cannot be certified and therefore released?
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