EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter
The European Medicines Agency (EMA) published an update to its “Quality of Medicines: Questions and Answers – Part 2”. The revision concerns the section on “Reduced testing of incoming starting materials”.
The EMA clarifies that reduced testing of incoming starting materials is a GMP matter and should not be reflected in the specifications described in the marketing authorisation dossier.
The Agency refers manufacturers of human medicinal products to EU GMP Part I, Chapter 5 (sections 5.27–5.39), while manufacturers of veterinary medicinal products are referred to Article 28 of Commission Implementing Regulation (EU) 2025/2091.
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