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GMP News

03.12.2025

Updated Q&As for Centralised Procedures - pre-authorisation procedural advice

In October 2025, the 'Questions & Answers (Q&A)' document relating to topics before and during the application process - 'European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure' - was updated again and published on the website of the European Medicines Agency (EMA).

03.12.2025

Deficient Water System: Warning Letter from the FDA

During an inspection in spring 2025, the FDA identified serious violations of GMP requirements at a US manufacturing facility for topical OTC medicines. The FDA deemed the response letter submitted to be insufficient, as it did not provide any reliable evidence or specific corrective measures.

03.12.2025

What are GMP Audits and what Qualifications do GMP Auditors need to have?

Conducting GMP audits is an essential tool for monitoring and continuously improving pharmaceutical quality systems. But what are the requirements?

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