“EU-GMP” and “PIC/S GMP” come up often in cannabis trade. You see them in buyer requirements, in export talks and on product labels. This post explains what each rulebook is and how closely the two match. It also shows how to check whether an “EU-GMP” claim is real. Near the end, a translator’s note explains what this means for growers and buyers in Thailand.
Two rulebooks, and who actually checks them
GMP stands for good manufacturing practice. These are rules on how medicines must be made, tested and recorded. Their purpose is to make every batch consistent and safe.
EU-GMP is the set of GMP rules that the European Union (EU) applies to medicines. A manufacturing site counts as EU-GMP compliant only after an inspector from a national medicines regulator in the EU has checked it against those rules. In trade, people often stretch the label to mean any goods that come out of such an inspected site.
PIC/S GMP is a parallel rulebook. It is kept by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a network of national medicines inspection bodies. The members agree on shared inspection standards so that each one can trust the others’ inspection reports.
The PIC/S text follows the EU text almost line for line. Any claim of PIC/S compliance rests on an inspection by one of the member regulators. PIC/S itself does not inspect anyone.
How the EU guide is organised
The European Commission, which runs the EU’s day-to-day work, publishes its medicines rules in a collection called EudraLex. Volume 4 of EudraLex is the GMP guide. It is a set of separate documents, not one single text:
| Section | What it covers |
|---|---|
| Part I | Basic requirements for medicinal products (finished medicines). It has nine chapters, running from the pharmaceutical quality system to self-inspection. |
| Part II | Basic requirements for active substances (the ingredient that gives a medicine its effect) when they are used as starting materials |
| Part III | Documents related to GMP. Examples: the site master file (a document describing the site, its buildings, equipment and quality system); ICH Q9 on quality risk management; ICH Q10 on the quality system |
| Part IV | GMP for advanced therapy medicinal products (medicines based on genes, cells or tissues) |
| Annexes | Rules for specific topics, applied on top of Parts I and II |
ICH is the International Council for Harmonisation. It brings regulators and the pharmaceutical industry together to write shared technical guidelines. “Q9” and “Q10” are guideline numbers in its quality series.
These annexes come up most often in cannabis discussions:
- Annex 1: making sterile medicines. The revised version has been fully applicable since 25 August 2024. Its rules for cleanrooms (rooms where airborne particles are kept below set limits) are the usual reference, even for products that are not sterile.
- Annex 7: making herbal medicines. It deals with starting materials that come from plants. This is the annex that touches cannabis plant material most directly.
- Annex 11: computerised systems. It covers how software and electronic records used in production must be checked and controlled.
- Annex 15: qualification and validation. Qualification is documented proof that equipment and rooms are installed correctly and work as intended. Validation is documented proof that a process gives the expected result every time.
- Annex 16: certification by a Qualified Person, and batch release. A Qualified Person is the named, legally responsible person who signs off each batch before it can be sold.
Translator’s note: If you plan a processing room built to cleanroom rules in Thailand, the climate system has to keep the room within its limits through 30–35 °C days, high rainy-season humidity and power cuts. Before you build, ask the designer how the room will stay within limits during a power outage.
What to do: When a buyer or consultant says something is “a GMP requirement”, ask which Part or Annex it comes from. The answer tells you whether the rule applies to your stage of work, or only to the factory that processes your material.
What PIC/S is, and its current guide
PIC/S describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP. Any authority with a comparable inspection system can apply to join. PIC/S currently has 57 participating authorities.
The PIC/S guide is document PE 009. The current version is PE 009-18. It was adopted on 22 September 2026 and has been in force since 24 September 2026.
The change from the previous version, PE 009-17, was a revised Annex 19 on reference and retention samples. A reference sample is a sample from a batch of starting material, packaging or finished product, kept so it can be tested later if a question arises. A retention sample is a fully packaged unit from a finished batch, kept to identify the product. The revised Annex 19 came in at the same time as the matching change in the EU guide.
The PIC/S guide has the same structure as the EU guide. It has an introduction, Part I for medicinal products, Part II for active substances used as starting materials, and annexes that apply to both parts.
Part II has its own history. In 2001 PIC/S adopted ICH Q7, the ICH guideline on GMP for active pharmaceutical ingredients, as a standalone text. In 2006 PIC/S made that text Part II of the main guide.
What to do: When a document cites PIC/S GMP, look at the version number. PE 009-18 is the current version and PE 009-17 is the one before it. An older version may cite rules that have since changed.
How close are the two guides?
They are very close, and that is deliberate. 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. Since then, the two have been developed side by side. Whenever one changes, the other is amended, so they stay practically identical.
A co-operation agreement between PIC/S and the European Medicines Agency (EMA) requires them to stay aligned. The EMA is the EU agency that coordinates the evaluation and supervision of medicines across EU countries.
PIC/S lists the differences between the two guides. Most of them are legal wording:
| Point | EU guide | PIC/S guide |
|---|---|---|
| Person who certifies batches | “Qualified Person” | “Authorised person” |
| Pharmacopoeia (the official book of quality standards and test methods for medicines) | European Pharmacopoeia | European or other relevant pharmacopoeia |
| References to EU directives (EU laws) and to mutual recognition agreements (MRAs: agreements under which the EU and another country accept each other’s inspections) | Included | Deleted |
| Definition of the product | “Medicinal product” | Keeps the “pharmaceutical product” definition from the PIC Convention, the earlier inspection agreement that came before the scheme |
For a manufacturer, the technical content is the same. The real differences are who inspects the site, and what legal recognition comes with that inspection.
What to do: If a buyer asks for “EU-GMP” and your processing partner offers “PIC/S GMP”, don’t argue about which one is stricter. Ask the buyer which inspecting authority they will accept. That answer decides whether the deal can go ahead.
What “EU-GMP certification” really means
No private company can issue an EU-GMP certificate. According to the EMA, each EU country’s national competent authority (its medicines regulator) inspects the manufacturing sites on its own territory.
A site outside the EU is inspected by the authority of the EU country where the EU importer is based. There is one exception. If the site’s country has an MRA with the EU, the authorities can rely on each other’s inspections.
After an inspection, the authority issues one of two documents: a GMP certificate or a statement of non-compliance. The result is entered in EudraGMDP. This is the EU database of manufacturing authorisations and GMP certificates. Its public version has been online since 2011.
So credible proof behind an EU-GMP claim has three parts. It is a certificate from a named EU authority, it covers a named site, and you can find it in EudraGMDP. None of the following counts as proof:
- a logo on a website;
- a consultant’s gap audit (a check of how far a site is from the standard, done before any official inspection);
- a “pre-certification”.
The EMA is also clear about how far the rules reach. Any manufacturer of medicines intended for the EU market must comply with EU GMP, wherever in the world it is located.
What to do: Before you sign with a partner who claims “EU-GMP”, ask for three things: the certificate number, the issuing authority and the exact site address. Then search the public EudraGMDP database and check that all three match. This tells you whether the site really passed an EU inspection, or whether you are only being shown a claim.
Where Thailand fits
Thailand’s Food and Drug Administration (Thai FDA) became the 49th PIC/S participating authority on 1 August 2016. PIC/S admits only authorities with a comparable GMP inspection system. Membership therefore says something about the quality of the Thai FDA’s inspection work.
PIC/S membership is not the same as an MRA with the EU. Under the EMA’s rules, the EU relies on another country’s inspections only through an MRA. A Thai manufacturer that exports medicines to the EU should expect an EU authority to decide whether to inspect. It should not assume that a Thai GMP licence will be accepted automatically.
What to do: Before you plan any export of medicines to the EU, check the EMA’s current list of MRA partner countries. If Thailand is not on it, budget time and money for an EU inspection.
What this means for growers in Thailand
Translator’s note: Most Thai cannabis farms will never run a GMP site themselves. They grow and dry plant material, then sell it to a processor or exporter. EU GMP Annex 7 places growing, collecting and harvesting under good agricultural and collection practice (GACP). Later steps, such as cutting and drying, can already fall under GMP. A GMP manufacturer still has to prove where its plant material came from, so your farm records end up in its paperwork.
Translator’s note: Steps you can take now, and why each one matters:
- Keep a GACP record for every batch. Record the plant source, every input and spray, the harvest date and the drying conditions. If a GMP buyer audits its suppliers, you can then trace any batch back to its origin.
- Ask your buyer which site will process your material. If they say it is EU-GMP, check that site in EudraGMDP. This tells you whether your material can realistically reach an EU medical market.
- Spray only pesticides registered with the Department of Agriculture (กรมวิชาการเกษตร), and follow the label. Buyers working to GMP will usually test incoming material. Residues found in testing can get a whole batch rejected.
- Don’t pay anyone for “EU-GMP certification”. Only an EU authority issues that certificate. A consultant can offer a gap audit, which is useful for preparation, but it is not certification.
- If you plan to supply an extraction site, check its Thai licence. Under the Ministerial Regulation on Cannabis or Hemp Extracts B.E. 2569, in force since 26 April 2026, licences for extracts above 0.2% THC go only to three kinds of holder: Thai juristic persons that are not “foreign” under the Foreign Business Act B.E. 2542, state agencies, and the Thai Red Cross Society. See the summary of the two B.E. 2569 regulations. A GMP certificate does not replace this licence.
Translator’s note: The same check applies to products sold in Thailand with “EU-GMP” on the label, such as cannabidiol (CBD) oils. Look the site up in EudraGMDP before you trust the claim. Thai law also limits what can be sold. Cannabis flower (ช่อดอกกัญชา) is a controlled herb under the Notification of the Ministry of Public Health Re: Controlled Herbs (Cannabis), B.E. 2568, issued under the Thai Traditional Medicine Protection Act B.E. 2542. It has been in force since 26 June 2025. Flower may be sold only with a PT 33 (ภ.ท.33) prescription, for at most 30 days. Advertising and online sale of flower are prohibited. An online post selling “EU-GMP flower” is therefore not allowed in Thailand, whatever certificate it shows.
Common mistakes
- Saying a product is “PIC/S certified”. PIC/S does not inspect or certify sites. A participating authority does, using the PIC/S guide. Ask which authority inspected the site.
- Treating EU-GMP and PIC/S GMP as different quality levels. The technical text is kept practically identical. The difference is the inspecting authority and the legal recognition.
- Citing an outdated version. The current PIC/S guide is PE 009-18, and PE 009-17 is the previous version.
- Assuming Part I covers everything. Active substances fall under Part II, and plant-derived material also brings in Annex 7.
- Taking a certificate at face value. Check that it appears in EudraGMDP with the same site and the same issuing authority.
Check the current version first
The guides and annexes are revised regularly. Before you rely on any section or annex number quoted here, check the current EudraLex Volume 4 and PIC/S pages.
Has a buyer asked you for GMP or GACP documents? Has a consultant offered you “EU-GMP certification”? Post your question or experience below this topic so other growers can learn from it.
References
- European Commission. EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Parts I–IV and Annexes 1, 7, 11, 15, 16 and 19. EudraLex - Volume 4 - Public Health - European Commission
- Pharmaceutical Inspection Co-operation Scheme (PIC/S). Guide to Good Manufacturing Practice for Medicinal Products, PE 009-18 (adopted 22 September 2026, in force 24 September 2026), including its introduction and list of differences from the EU guide. https://picscheme.org/en/publications?tri=gmp
- PIC/S. List of participating authorities (Thai FDA, participating authority since 1 August 2016). https://picscheme.org/en/members
- European Medicines Agency (EMA). Pages on GMP inspections (Good manufacturing practice | European Medicines Agency (EMA)), mutual recognition agreements (Mutual recognition agreements (MRA) | European Medicines Agency (EMA)) and the EudraGMDP database (EudraGMDP database | European Medicines Agency (EMA)).
- ICH. Guidelines Q7 (GMP for active pharmaceutical ingredients), Q9 (quality risk management) and Q10 (pharmaceutical quality system). ICH Official web site : ICH