PIC/S PE 009-18: What Changed in the Revised GMP Guide

PIC/S PE 009-18 is the new version of the GMP Guide of the Pharmaceutical Inspection Co-operation Scheme, adopted on 22 September 2026 and in force since 24 September 2026. The revision supersedes PE 009-17 and introduces a single — but significant — change: it incorporates the revised Annex 19 on reference and retention samples, with a rewritten Section 9 for parallel imported, parallel distributed and parallel traded products. In this article we look at what changes in practice, who is impacted, and which checks QA teams and Qualified Persons should schedule right away.

PIC/S PE 009-18: what it is and when it applies

PIC/S (the Pharmaceutical Inspection Co-operation Scheme) brings together more than 50 inspection authorities worldwide around harmonised GMP standards. The scheme's core document is the PE 009 GMP Guide, structured in three blocks: Part I (basic requirements for medicinal products), Part II (GMP requirements for active substances) and the Annexes, which largely mirror the annexes of the European EudraLex Volume 4.

Version PE 009-18 was adopted by the PIC/S Committee by written procedure on 22 September 2026 and entered into force on 24 September 2026. The date is no coincidence: it matches the application date of the revised Annex 19 in the European Union, published by the European Commission on 23 June 2026 as guideline C(2026) 4135 and applicable three months later. The simultaneous update stems from the cooperation agreement between PIC/S and the EMA, designed to keep the GMP standards of the two frameworks equivalent and to facilitate the exchange and mutual use of inspection information. Participating authorities outside the European Economic Area have been invited to transpose the revised Annex 19 into their own national GMP guides.

What changed compared to PE 009-17

Anyone who remembers the transition to PE 009-17 — the version that incorporated the new Annex 1 on sterile manufacturing in August 2023 — will find PE 009-18 far more contained. Part I, Part II and all other Annexes remain unchanged: the only document affected is Annex 19. The table summarises the comparison.

The PIC/S and EU frameworks are moving more and more in sync: if you want a pragmatic reading of revisions like this one every week, with the actions to take before your next audit, subscribe to The Pragmatic GMP, GuideGxP's free weekly newsletter.

Annex 19: what it requires for reference and retention samples

Annex 19 governs reference samples (kept for analytical purposes) and retention samples (kept to identify the finished product as placed on the market). The revised structure comprises ten sections: scope, principle, duration of storage, size of samples, storage conditions, written agreements, general points on reference samples, general points on retention samples, parallel traded products, and closedown of a manufacturer. The operational cornerstones to keep under control:

• Duration of storage: finished product samples are retained for at least one year after the expiry date; starting material samples for at least two years after product release, which may be shortened if documented stability is shorter.
• Packaging materials: the materials used must be retained for the whole shelf life of the finished product.
• Accessibility: the Qualified Person who certifies the batch must ensure that all relevant reference and retention samples are accessible at all reasonable times, even when storage is delegated to third parties under written agreements.
• Representative sampling: samples must represent the batch in the form actually distributed, including primary and secondary packaging.

The rewritten Section 9: parallel trade and digital samples

Who is impacted, concretely? Directly, manufacturers and MA holders active in non-EU PIC/S markets (Switzerland, the United Kingdom, the United States, Canada, Australia and many others) and anyone involved in repackaging for parallel trade. Indirectly, every GMP site: in audits and self-inspections the version of the guide you cite must be the current one, and a reference to PE 009-17 in an SOP updated in 2027 is the classic easy-to-avoid finding.

The heart of the revision is Section 9, dedicated to parallel imported, parallel distributed and parallel traded products — batches repackaged to be placed on another market. The rules are now explicit:

1. A retention sample must be taken for each repackaging operation and retained for one year beyond the expiry date, including primary and secondary packaging.
2. Reference samples of the repackaged product are not required: they remain with the original manufacturer.
3. The packaging materials used in repackaging must be retained for the entire shelf life of the product.
4. Where justified and agreed in advance with the competent authority, a photographic or digital sample is permitted as an alternative to the physical retention sample: a significant opening for companies managing many packaging variants, but one that requires a documented rationale and a formalised agreement before abandoning the physical sample.

For parallel import authorisation holders and for sites performing contract repackaging, Section 9 is the item to bring into a gap analysis: many operators relied on local interpretations that now have a harmonised reference, valid in European inspections as much as in those of non-EU PIC/S authorities.

GuideGxP recommendation

Since the revision is already in force, the job is not to "prepare" but to verify alignment. In practice:

• update the document references in your quality system: SOPs citing PE 009-17 must point to PE 009-18, and those on reference and retention samples must reflect the revised Annex 19;
• if you operate in parallel trade, run a gap analysis against Section 9: one sample per repackaging operation, coverage of primary and secondary packaging, retention of packaging materials;
• if you are considering photographic or digital samples, prepare the rationale and formalise the agreement with the competent authority before changing practice;
• check written agreements with third-party storage sites: sample access times and responsibilities must stand up to the inspector's question "can the QP access them at all reasonable times?".

If you want operational support on these topics, GuideGxP's Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices covers sterility, qualification and validation, QP certification and quality risk management in a single framework, with cross-references to Annex 19 and the PIC/S framework: the right tool to turn the revision into audit-ready procedures.

Official sources

• PIC/S – Revision of PIC/S GMP Guide (PE 009-18)
• PIC/S – Publications (full text of the PE 009 GMP Guide)
• European Commission – Guideline C(2026) 4135: EudraLex Volume 4, revised Annex 19
• European Commission – EudraLex Volume 4 (EU GMP)