Proposed EU GMP Annex 16 update

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?