GMP News - Quality Assurance

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.

In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised procedures were again updated and published on the website of the European Medicines Agency (EMA).

Often pharmaceutical companies overinterpret GMP rules, leading to unnecessary processes that can inflate costs and reduce efficiency. To right-size GMP and compliance, and move towards lean GMP-systems, companies can consider several strategies.

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.

Inspection results often help with the interpretation of regulatory requirements. The FDA Warning Letters are a very good source for that purpose. A recent Warning Letter criticises deficiencies in process validation. What did the FDA object to?

As we reported at the end of last year, China has revised its counter-espionage law. Now there are fears that this will also affect GMP inspections and audits, as the German Handelsblatt writes.