Regulatory requirements in the pharmaceutical industry are expected to increase further. The changes made in the revision of Annex 1 show, that developments in manufacturing and testing as well as quality risk management principles, are now more extensively taken into account.
Katja Kotter, Vice President Regulatory Affairs/ Quality Compliance, Vetter
Minimizing the risk of microbial, particulate and pyrogen contamination and therefore ensuring the sterility of the manufactured products is one of the focus topics of the outlined draft of the EU GMP Annex 1. At Vetter, we have been expecting this industry trend and have already a comprehensive contamination control strategy in place.
Julia Allgaier, Lead Expert Contamination Control, Vetter
cGMP for your clinical batch
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