PIC/S Guide to Good Manufacturing Practice (PE 009)

PIC/S · In force

Last verified: not yet

Unverified: the editor has not yet checked this record against the official source.

Summary

The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.

Dated events

1. 30 Oct 2026 Checked: PE 009-18 listed as current on PIC/S publications page Source for Checked: PE 009-18 listed as current on PIC/S publications page
2. 23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17 Source for PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17

Official source

Official text

Summary in our own words. See the official text from PIC/S.