Can extraction equipment itself be EU GMP certified?

No. EU GMP certificates are issued to manufacturing sites by national competent authorities — never to machines or the companies that build them. Equipment supports a site's certification by being cleanable, traceable, and qualifiable, which is why design and documentation matter more than any label.

What documentation should EU GMP-oriented extraction equipment come with?

Expect material certificates for product-contact stainless, weld documentation where applicable, component-level records, and packages to support IQ/OQ/PQ. Scope varies by model and configuration, so agree the document list in writing before the purchase order — certificates are easy to supply during a build and very hard to reconstruct afterwards.

What makes equipment "cleanable" in EU GMP terms?

Cleanability means cleaning can be proved, not just performed: appropriate surface finishes, drainable geometry, no dead legs, and a defined procedure with acceptance criteria whose results you can hand an inspector. Gasket and seal materials count too, since they are product-contact components with their own documentation requirements.

What are IQ, OQ and PQ?

They are the three stages of equipment qualification: IQ confirms the system was installed to specification, OQ confirms it operates correctly across its intended range, and PQ confirms it performs consistently under real production conditions. Annex 15 sets the European expectations for this work.

Why is swapping a gasket or filter a compliance issue?

Under GMP, a change to a product-contact component is a documented change, not a maintenance decision. An informal substitution can invalidate cleaning validation, which is why a consistent spare parts and consumables chain is part of staying compliant.

EU GMP Extraction Equipment Requirements

What EU GMP asks of extraction equipment — cleanability, material traceability, IQ/OQ/PQ qualification, control system data integrity and change control.