A concept paper on the revision of Annex 11
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP)…
PIC/S Annual Report 2021
by Giuliana Miglierini The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and…
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16
by Giuliana Miglierini The entry into force of EU Regulation 536/2014 “Clinical trials”, at the end of January,…