What it is and the current version
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) links GMP inspectorates around the world, and the US FDA is a member. Its GMP guide, PE 009, is closely aligned with the EU GMP guide and is used as the national GMP standard by many member authorities.
Version timeline:
| Version | What changed | In force |
|---|---|---|
| PE 009-17 | Revised Annex 1 (sterile manufacturing), nearly identical to EU Annex 1 | 25 August 2023 (paragraph 8.123 from 25 August 2024) |
| PE 009-18 | Revised Annex 19 (reference and retention samples); Section 9 clarification from PE 009-17 kept | 24 September 2026 |
So as of late October 2026, PE 009-18 is the current version, and any AI index still holding PE 009-17 is one month out of date.
PIC/S also co-drafted the EU’s 2025 Chapter 4, Annex 11, and new Annex 22 (AI) consultations, so changes there are likely to flow into PE 009 later.
Where to find it
- PIC/S website (picscheme.org): publications, news, and the GMP guide in parts and annexes.
- Member authorities such as Singapore’s HSA or Australia’s TGA, which state which PE 009 version they apply.
Reuse terms: why “check required”
The PIC/S pages we opened announce versions but do not set out reuse terms for the guide. Because PE 009 largely mirrors EU texts, some content may also be available under the EU’s more open terms, but PIC/S documents should not be assumed to carry the same licence. Before full-text AI use:
- check the notice on the PDF you use,
- ask the PIC/S Secretariat if no terms are stated, and
- acknowledge PIC/S as the source.
Using PE 009 in AI and RAG
- Store the version number (PE 009-18) and in-force date on every chunk.
- Archive PE 009-17 and label it superseded from 24 September 2026.
- Map PIC/S annexes to EU annexes and note where they differ.
- Record which member authority applies which version for country-specific answers.
- Confirm reuse terms before including full text in a commercial tool.
- Monitor PIC/S news for new versions, especially after the EU Annex 11 and Annex 22 work concludes.
Common mistakes
- Still using PE 009-17 after 24 September 2026.
- Assuming PIC/S and EU texts are identical without checking.
- Assuming EU CC BY terms automatically cover PIC/S PDFs.
- Forgetting that member authorities may adopt a new version on their own timeline.
Checklist
- PE 009-18 indexed with in-force date
- PE 009-17 archived
- EU and PIC/S annexes mapped
- Member authority adoption recorded
- Reuse terms confirmed
- PIC/S news monitored
How AskDona helps
AskDona checks your retention sample procedure, sterile manufacturing controls, and other SOPs against the PIC/S version you specify, and flags when a finding relies on a superseded version.
Run a sample PE 009-18 Annex 19 check
AskDona shows the evidence; your QA team decides.
Editor’s note. This article is general information, not legal advice. The “check required” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
What is the current PIC/S GMP guide? PE 009-18, in force since 24 September 2026.
What changed in PE 009-18? A revised Annex 19 on reference and retention samples.
Is PIC/S Annex 1 the same as EU Annex 1? Nearly identical, according to PIC/S.
Can I put PE 009 into a commercial AI tool? Check the PDF’s notice and ask PIC/S if unclear. Do not assume EU licence terms apply.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| PIC/S: Entry into force of revised Annex 1 (PE 009-17) | PE 009-17 dates; PE 009-18 in force 24 Sep 2026 with revised Annex 19 |
| Commission consultation: Chapter 4, Annex 11, Annex 22 | Drafts prepared with PIC/S |