Who issues an EU GMP certificate, and to whom?

The national competent authority of the EU member state where a site operates issues the certificate — to the manufacturing site, for defined activities. No trade body, equipment vendor, or certification mark on a machine can confer it.

Does buying "EU GMP equipment" make my facility compliant?

No. Compliance never transfers with a purchase, and no extractor is "EU GMP certified" in itself. What well-designed equipment does is make your site's certification straightforward to obtain and defend, through cleanability, traceability, and qualification support.

Does cannabis extraction fall under Part I or Part II of EudraLex Volume 4?

A cannabis extract used as an active substance is generally handled under Part II, while Part I applies once it is formulated into a finished medicinal product. Which part applies to your operation follows from the product, its intended use, and the marketing authorisation — confirm it with the competent authority rather than assuming.

What do Annex 11 and Annex 15 mean for extraction equipment?

Annex 15 sets the expectations for qualification and validation (IQ, OQ, PQ), so equipment needs defined, testable specifications. Annex 11 governs computerised systems, which puts your control system, audit trails, and batch records under scrutiny for data integrity.

Where does GACP end and GMP begin?

Cultivation upstream is usually governed by GACP rather than GMP. The handover point between the two is worth defining early, because it determines where your documented chain of custody has to begin.

What is EU GMP in Cannabis Extraction?

EU GMP is the European Good Manufacturing Practice framework medicinal cannabis facilities are certified against. Learn what it covers and what it asks of extraction equipment.