Can extraction equipment be EU GMP certified?

No. EU GMP certificates are issued to manufacturing sites by a national competent authority after an inspection, and are published in the EudraGMDP database. Equipment cannot hold one. What equipment can be is EU GMP-ready: designed for cleaning and inspection, supplied with the documentation your qualification programme needs, and capable of producing the records an inspector will ask to see.

What is the difference between GMP and EU GMP for cannabis?

GMP is the general concept of manufacturing under a controlled, documented quality system. EU GMP is the specific set of rules published in EudraLex Volume 4 and enforced by EU/EEA national competent authorities for medicinal products. A facility can run to GMP principles without holding an EU GMP certificate; supplying medicinal cannabis into most EU markets requires the certificate.

Does EU GMP apply to cultivation as well as extraction?

Cultivation and primary processing of a herbal starting material are normally covered by GACP, the EMA's Good Agricultural and Collection Practice guideline. EU GMP applies once you are manufacturing the active substance or the medicinal product. Exactly where the boundary falls is interpreted by each national competent authority, so confirm it with your regulator before designing your process flow.

Which EU GMP annexes matter most for extraction equipment?

Annex 15 governs qualification and validation, which is where DQ, IQ, OQ and PQ come from. Annex 11 governs computerised systems, which covers your control system's audit trail, user access and data integrity. Annex 7 covers herbal medicinal products. Chapter 3 of Part I sets the general premises and equipment expectations, including that equipment be designed for thorough cleaning.

Is hydrocarbon extraction acceptable under EU GMP?

Yes, provided residual solvent is controlled and demonstrated. EU GMP does not prohibit a solvent class; it requires that your process be validated and that the finished product meet its specification, including residual solvent limits derived from ICH Q3C. In practice hydrocarbon systems draw more scrutiny on the hazardous-area design and the solvent purge and testing regime, not on the chemistry itself.

What documentation should an equipment supplier provide?

At minimum: material certificates for product-contact components, weld documentation where applicable, instrument calibration certificates with traceability, electrical and P&ID drawings, the control system description, and an operation and maintenance manual. This is the evidence your IQ and OQ protocols reference. Ask for the specific document list in writing before you order, because scope varies by supplier and configuration.

How long does EU GMP qualification of new equipment take?

It depends on your quality system's maturity far more than on the equipment. The sequence is user requirement specification, design qualification, factory and site acceptance testing, then IQ, OQ and PQ, followed by process and cleaning validation. Facilities that write the URS before selecting equipment move through it materially faster than those that qualify a machine they have already installed.

Are Decimal extraction systems suitable for EU GMP facilities?

Decimal systems are designed to support EU-GMP facility compliance: stainless product-contact construction, ASME code construction available on qualifying pressure vessels, UL-recognized electrical components, and C1D1-rated components on specific models. Decimal does not hold an EU GMP certificate; that certification applies to medicinal-product manufacturing sites, not to equipment or to equipment manufacturers. Documentation scope varies by model and configuration, so confirm what your qualification programme needs with engineering before you order.

EU GMP Cannabis Extraction Equipment

No extractor is “EU GMP certified” — certificates go to sites, not machines. What EU GMP requires of cannabis extraction equipment, and how to evaluate it.