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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.

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

Version Timeline

Chronological release history

PE 009-18

Version milestone

Published en

Publication Date

23 Sept 2026

Effective Date

24 Sept 2026

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