GMP News - Quality Assurance

The European Medicines Agency (EMA) has published the Template for the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain - "The QP declaration template". Read more.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures has revised the Q/A-List for the Submission of Variations adding a question and answer regarding the submission of the results of confirmatory stability studies on production-scale batches. Read more.

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Read more.

The CMDh is answering a question about the relevance of a QP Declaration when a GMP Certificate was not provided. Read more.

The last year was a difficult year for the FDA and the agency had to suffer from budget restrictions. Despite that, a lot of actions were ongoing. Here is a short summary of some selected activities.

The last year was an interesting year for those who have to have an eye on GMP regulations in the European Union. The EU GMP Guide is under constant revision. Here is an overview.

Manufacturing of Radiopharmaceuticals includes some specific challenges. To provide additional guidance for these establishments, the PIC/S Committee's new Annex 3 to PE 010-3 is in the final stages for adoption. Read more here.