Sources
The documents behind every clause we cite
Our pages explain requirements in our own words. Here is the official text each clause comes from, the version we read, and whether our copy is identical to the one the publisher serves today. The basis is EU GMP as published by the European Commission; sources from outside the EU come last and are marked as additional.
EU GMP Part I, by chapter
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EU GMP Part I, ch. 1 — Pharmaceutical Quality System
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EU GMP Part I, ch. 2 — Personnel
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EU GMP Part I, ch. 3 — Premise and Equipment
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EU GMP Part I, ch. 4 — Documentation
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EU GMP Part I, ch. 5 — Production
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EU GMP Part I, ch. 6 — Quality Control
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EU GMP Part I, ch. 7 — Outsourced activities
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EU GMP Part I, ch. 8 — Complaints and Product Recall
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EU GMP Part I, ch. 9 — Self Inspection
EU GMP Parts II, III and IV
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EU GMP Part II — Basic requirements for active substances used as starting materials
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EU GMP Part III, Site Master File — Explanatory notes on the preparation of a Site Master File
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EU GMP Part IV — Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, C(2017) 7694
EU GMP annexes
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EU GMP Annex 1 — Manufacture of Sterile Medicinal Products
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EU GMP Annex 2 — Manufacture of Biological active substances and Medicinal Products for Human Use
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EU GMP Annex 3 — Manufacture of Radiopharmaceuticals
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EU GMP Annex 6 — Manufacture of Medicinal Gases
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EU GMP Annex 7 — Manufacture of Herbal Medicinal Products
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EU GMP Annex 8 — Sampling of Starting and Packaging Materials
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EU GMP Annex 9 — Manufacture of Liquids, Creams and Ointments
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EU GMP Annex 10 — Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
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EU GMP Annex 11 — Computerised Systems
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EU GMP Annex 12 — Use of Ionising Radiation in the Manufacture of Medicinal Products
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EU GMP Annex 13 — Detailed Commission guideline of 8 December 2017 on good manufacturing practice for investigational medicinal products, C(2017) 8179
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EU GMP Annex 14 — Manufacture of Products derived from Human Blood or Human Plasma
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EU GMP Annex 15 — Qualification and validation
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EU GMP Annex 16 — Certification by a Qualified Person and Batch Release
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EU GMP Annex 17 — Real Time Release Testing and Parametric release
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EU GMP Annex 19 — Reference and Retention Samples (revised), C(2026) 4135
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EU GMP Annex 19 (2005) — Reference and Retention Samples (version of 14 December 2005)
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EU GMP Annex 21 — Importation of medicinal products
Adopted in the EU
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ICH Q3C — Impurities: Guideline for Residual Solvents, Q3C(R9)
Beyond the EU — additional sources, not the basis of this site
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SAHPRA — Guideline for the cultivation and manufacture of cannabis and cannabis products
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Lesotho LN40 — Drugs of Abuse (Cannabis) Regulations 2018, Legal Notice No. 40
Versions and dates are copied from the publisher’s own page — for EU GMP, EudraLex Volume 4 — on 1 October 2026. An identical copy means the file we read and the file published today have the same SHA-256 fingerprint. Where a clause is our own design decision rather than a regulation, the page says so next to it.
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