PIC/S revises GMP Guide to update requirements for reference and retention samples

23rd September 2026

Summary: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published version PE 009-18 of its GMP Guide, incorporating a revised Annex 19 on reference and retention samples. The changes primarily concern Section 9, which addresses samples for parallel imported, distributed and traded medicinal products. The revision retains clarification that these provisions apply where relevant local legislation exists. The update supports continued harmonisation between PIC/S and EU GMP requirements, helping maintain consistent standards for pharmaceutical manufacturing and inspection.

Link https://picscheme.org/en/news/

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