PIC/S GMP Guide PE 009-18 in force: revised Annex 19 on reference and retention samples

In short: PIC/S issued a new edition of its GMP Guide, PE 009-18, which includes the revised Annex 19 (reference and retention samples). According to PIC/S, it entered into force on 24 September 2026.

What changed

PIC/S announced in Geneva on 23 September 2026 that the Committee had adopted the revised Annex 19 by written procedure on 22 September 2026, and that the GMP Guide was updated to PE 009-18 to include it. The edition is published as four parts on the PIC/S publications page: Introduction, Part I, Part II and Annexes. The Annexes document carries the date 24 September 2026 on each page.

The PIC/S announcement singles out Section 9 of Annex 19, which covers reference and retention samples for parallel imported, parallel distributed and parallel traded products. The note that Section 9 applies only where national legislation deals with such products was already in PE 009-17 and has been kept.

Annex 19 in PE 009-18 is organised in ten sections: scope, principle, duration of storage, size of samples, storage conditions, written agreements, reference samples, retention samples, parallel-traded products, and closedown of a manufacturer. Points that stand out in the text:

• Reference and retention samples of each finished-product batch are kept for at least one year after expiry.
• Starting-material samples (other than solvents, gases and water) are kept at least two years after release of the finished product, unless a longer period is required or the material’s stability is shorter.
• A reference sample must allow the full analytical controls to be done at least twice, and the analytical materials and equipment must remain available until one year after expiry of the last batch.
• For re-packaged parallel-traded products, no reference sample is required, but a retention sample is taken for each re-packaging operation and kept at least one year after expiry.
• Some paragraphs (for example the closedown section 10) are marked as specific to the EU Guide and not adopted by PIC/S.

Because the document does not mark changes against PE 009-17, this explainer cannot say which individual sentences are new.

PIC/S says the update follows the PIC/S–EMA Co-operation Agreement, which calls for harmonising the PIC/S and EU GMP Guides. The European Commission published the revised Annex 19 in EudraLex Volume 4 on 23 June 2026, and the PIC/S entry into force matches the EU date.

Who it affects

PIC/S has invited non-EEA Participating Authorities and Applicants to transpose Annex 19 into their own GMP Guides, so the effect on a manufacturer depends on how its inspectorate adopts the Annex. Parallel-trade products are the main subject of the Section 9 revision, so most Indian manufacturers of their own products will see little direct change.

Key dates

• 23 June 2026: European Commission publishes revised Annex 19 (per PIC/S).
• 22 September 2026: Annex 19 adopted by the PIC/S Committee (written procedure).
• 23 September 2026: PIC/S announcement.
• 24 September 2026: PE 009-18 enters into force.

What to do now

• Check whether your retention-sample SOP refers to the old edition number (PE 009-17) and update the reference.
• Compare your sample sizes, storage periods and written agreements with sections 3, 4 and 6 of the Annex.
• If you handle parallel imported or distributed products, read Section 9 against your current practice.
• Ask regulatory affairs which edition your customers’ auditors will use. This is an example in-house approach, not a regulatory requirement.

Related reading: Process Validation in Pharmaceutical Industry.

Official source

• Revision of PIC/S GMP Guide (PE 009-18) — PIC/S, 2026-09-23. Link. Annexes: PE 009-18 Annexes.