EU-GMP Annex 7 — Manufacture of Herbal Medicinal Products
Where GACP ends and pharmaceutical manufacturing begins. Annex 7 governs the processing of herbal — including cannabis-derived — starting materials into API and finished medicinal product, under the same GMP discipline as any other drug substance.
Pharmaceutical-grade discipline, applied to a botanical input.
Annex 7 sits inside the same EU-GMP framework used for any medicinal product, applied to herbal and cannabis-derived starting materials once they enter manufacturing: manufacturing authorization, Qualified Person (QP) batch release, validated processes, environmental monitoring of manufacturing — not just cultivation — areas, change control, deviation and CAPA management, and supplier qualification reaching all the way back to the GACP-certified cultivator.
Qualified Person Sign-Off
A documented QP release decision behind every batch — the single most load-bearing signature in the whole system.
Validated Processes
Extraction and processing steps run and monitored within qualified parameters, with the validation records to prove it — not ad hoc adjustments made on the floor.
Supplier Qualification
Audited, on-file evidence for every upstream cultivator — typically the same GACP certification this facility may already hold.
Change Control
Any process or equipment change formally assessed and documented before it ships product, with the rationale on record.
Usually a scale-up decision, not a starting point.
This is the certification for facilities chasing EU premium markets that require CUMCS or EU-GMP equivalence — domestic certification already in hand, now extending into manufacturing. Equipment qualification (IQ/OQ/PQ) is planned around the systems you already run, whoever made them.