Consultation open on the revision of GMP’s Chapter 1

Comments on the draft revision of Chapter 1 of the Good Manufacturing Practices must be submitted by 3 December 2025. The revision aims to update this fundamental text in light of the more recent advancements in pharmaceutical manufacturing, so to better ensure the ef-fectiveness and safety of medicinal products. The EIPG will liaise with member associations to submit a joint response to the draft text.

PIC/S’ new guidances on remote and hybrid inspections

Two new guidance published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) discuss the different types of remote assessment, including hybrid inspections, and provide a harmonised approach to their conduct. The PIC/S also revised its guideline for the accession to the Scheme by interested regulatory agencies

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…