EMA updates Q&A on Reduced Testing of Incoming Starting Materials

The European Medicines Agency (EMA) has published an update to its “Quality of medicines: questions and answers – Part 2”. The update focuses on the section “Reduced testing of incoming starting materials”.

The question is: "What information should be included in marketing authorisation dossiers regarding the actual testing performed by the finished product manufacturer, on receipt of any incoming starting materials (e.g. active substances, excipients, packaging materials, etc) and before use in production of the medicinal product?"

The Q&A clarifies that what is actually tested on receipt is governed by GMP, so the registered incoming material specifications in the marketing authorisation dossier should not reference reduced testing.

The full question can be found on the EMA website.