EU-GMP is shorthand for the good manufacturing practice rules that the European Union applies to medicines, and a manufacturing site counts as EU-GMP compliant only after an inspector from a national regulator in the EU has checked it against those rules; in trade, the label is often stretched to describe goods coming out of such an inspected facility. PIC/S GMP is the parallel rulebook kept by the Pharmaceutical Inspection Co-operation Scheme, a network of national inspectorates that agree on shared inspection standards so they can trust one another’s reports. Its wording tracks the EU text almost line for line, and the inspection behind any compliance claim is carried out by a member regulator — PIC/S as an organisation inspects nobody. This post explains how the two guides are built, how closely they match, and what genuine proof of compliance looks like.
How the EU guide is organised
The European Commission publishes the EU guide as EudraLex Volume 4. It is a set of documents rather than one text:
| Section | What it covers |
|---|---|
| Part I | Basic requirements for medicinal products, in nine chapters from the pharmaceutical quality system to self inspection |
| Part II | Basic requirements for active substances used as starting materials |
| Part III | GMP-related documents such as the site master file, ICH Q9 on quality risk management and ICH Q10 on the quality system |
| Part IV | GMP for advanced therapy medicinal products |
| Annexes | Topic-specific rules applied on top of Parts I and II |
The annexes most often raised in cannabis discussions:
- Annex 1: manufacture of sterile medicinal products, revised and fully applicable since 25 August 2024. Its cleanroom rules are the usual reference even for products that are not sterile.
- Annex 7: manufacture of herbal medicinal products, which deals with plant-derived starting materials.
- Annex 11 and Annex 15: computerised systems, and qualification and validation.
- Annex 16: certification by a Qualified Person and batch release.
What PIC/S is, and the current PIC/S guide
PIC/S describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP, open to any authority with a comparable inspection system. It currently has 57 participating authorities.
Its guide is document PE 009. The current version is PE 009-18, adopted on 22 September 2026 and in force from 24 September 2026. The change from PE 009-17 was a revised Annex 19 on reference and retention samples, introduced at the same time as the matching change in the EU. The structure mirrors the EU guide: an introduction, Part I for medicinal products, Part II for active substances used as starting materials, and annexes common to both parts. Part II has its own history. In 2001 PIC/S adopted the ICH Q7 guide for active pharmaceutical ingredients as a standalone text, and in 2006 it made that text Part II of the main guide.
How close are the two?
Very close, by design. The introduction to the PIC/S guide says the EU adopted its own GMP guide in 1989 as an equivalent of the PIC/S text, and that the two have since been developed in parallel: whenever one changes, the other is amended, leaving them practically identical. A co-operation agreement between PIC/S and the EMA requires this harmonisation. The differences PIC/S lists are mostly legal wording:
| Point | EU guide | PIC/S guide |
|---|---|---|
| Person who certifies batches | Qualified Person | Authorised person |
| Pharmacopoeia reference | European Pharmacopoeia | European or other relevant pharmacopoeia |
| References to EU directives and MRAs | Included | Deleted |
| Product definition | Medicinal product | Pharmaceutical product definition from the PIC Convention retained |
For a manufacturer the practical difference is who inspects and what legal recognition follows, not the technical content.
What “EU-GMP certification” actually means
There is no private EU-GMP certificate. According to the European Medicines Agency, national competent authorities inspect manufacturing sites on their own territory. A site outside the EU is inspected by the authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) between the EU and that country lets the authorities rely on each other’s inspections. After inspecting a site, the authority issues either a GMP certificate or a non-compliance statement, and the result is entered in EudraGMDP, the EU database whose public version has been available since 2011.
So the credible evidence behind an EU-GMP claim is a certificate from a named EU authority, for a named site, that can be found in EudraGMDP. A logo on a website, a consultant’s gap audit or a “pre-certification” is not that. The EMA is also clear on reach: any manufacturer of medicines intended for the EU market must comply with EU GMP wherever in the world it is located.
Where Thailand fits
Thailand’s Food and Drug Administration became the 49th PIC/S participating authority on 1 August 2016. Because PIC/S is open only to authorities with a comparable GMP inspection system, membership says something about the Thai FDA’s inspectorate. It is not the same as an EU mutual recognition agreement. Under the EMA’s rules, reliance on another country’s inspections comes from an MRA, so a Thai manufacturer exporting medicines to the EU should expect an EU authority to decide on inspection, rather than assume that a Thai GMP licence will be accepted automatically.
Common mistakes
- Saying a product is “PIC/S certified”. PIC/S does not inspect or certify sites; a participating authority does, against the PIC/S guide.
- Treating EU-GMP and PIC/S GMP as different quality levels. The technical text is kept practically identical; the difference lies in the inspecting authority and legal recognition.
- Citing an outdated version. The current PIC/S guide is PE 009-18; PE 009-17 is the previous version.
- Assuming Part I covers everything. Active substances fall under Part II, and plant-derived material brings in Annex 7.
- Taking a certificate at face value. Check that it appears in EudraGMDP under the same site and issuing authority.
Guides and annexes are revised regularly, so check the current EudraLex and PIC/S pages before relying on any section number quoted here.