The EMA has published a new Q&A addressing the requirement for Qualified Person (QP) certification of batches that are neither manufactured or physically imported in the EU/EEA market.
Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations during from in-process controls?
A US company received a Warning Letter because of problems at their CMO. FDA points out that companies should have a robust qualification process for CMOs.
EMA has published updated GMP Q&As on with two new questions dealing with third party audits. QPs should provide a written final assessment and approval of third-party audit reports.
The EMA has published a new version of the '3-year work plan for the Inspectors Working Group' for the period January 2025 to December 2027. This includes planned changes to the EU GMP guidelines.
The joint Q&A of CMDh and CMDv on the QP Declaration has been updated with the deletion of a part of an answer regarding changes to a Marketing Authorisation.
