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.
After inadequate root cause analyses were repeatedly the subject of FDA Warning Letters, another one was published on this topic. This time for a global company with a site in the USA.
