Search across the website

Find training courses, blog posts, guidelines, knowledge base articles and more.

to navigate esc to close to open
GMP Published

PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Annexes

The complete set of annexes to the PIC/S GMP Guide (PE 009), including Annex 1 (sterile products), Annex 11 (computerised systems), Annex 15 (qualification and validation), Annex 19 (reference and retention samples) and Annex 20 (quality risk management). Harmonised with the EudraLex Volume 4 annexes.

Organizations:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Version Timeline

Chronological release history

PE 009-18

Version milestone

Published en

Publication Date

Sep 23, 2026

Effective Date

Sep 24, 2026

Main updates: Annex 19 section 9 — reference and retention samples for parallel imported, parallel distributed and parallel traded products.
Open version Download