EMA’s 3-year work plan for the Quality domain
by Giuliana Miglierini The European Medicines Agency has released the input notes made by the GMDP Inspectors Working…
PIC/S new guidance documents for GDP inspectors
By Giuliana Miglierini Two new guidance documents for GDP inspectors have been issued by the Pharmaceutical Inspection Cooperation…
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,…
The new PIC/S guideline on data integrity
by Giuliana Miglierini The long waited new PIC/S guideline PI 041-1 has been finally released on July 1st;…