Links
Regulations at the source.
The regulations we work with every day, straight from the publisher and freely accessible. No summaries, no paywalls.
EU: GMP for medicinal products
- EudraLex Volume 4: EU GMP Guide (opens in a new window) Parts I, II and III and all annexes, each in the current version. Europäische Kommission
· Document: EN - Annex 1: Manufacture of Sterile Medicinal Products (2022) (opens in a new window) PDF, applicable since 25 August 2023. Europäische Kommission
· Document: EN - Annex 11: Computerised Systems (opens in a new window) PDF. Europäische Kommission
· Document: EN - Annex 15: Qualification and Validation (opens in a new window) PDF. Europäische Kommission
· Document: EN - Directive (EU) 2017/1572: GMP principles for medicinal products for human use (opens in a new window) Legal basis of GMP in the EU, in all official languages. EUR-Lex
· Document: DE/EN - EMA: Quality of water for pharmaceutical use (opens in a new window) Scientific guideline on Purified Water and WFI. European Medicines Agency
· Document: EN - EudraGMDP: GMP certificates and manufacturing authorisations (opens in a new window) Public database of the EU authorities. European Medicines Agency
· Document: EN - Guidelines on Good Distribution Practice (GDP) 2013/C 343/01 (opens in a new window) Storage and distribution of medicinal products for human use, including temperature mapping of storage areas (section 3.2.1). EUR-Lex
· Document: DE/EN
Germany
- AMWHV: German ordinance on the manufacture of medicinal products and active substances (opens in a new window) National implementation of the GMP requirements. Bundesministerium der Justiz
· Document: DE - AMG: German Medicinal Products Act (opens in a new window) Legal basis for manufacture and placing on the market. Bundesministerium der Justiz
· Document: DE - ZLG: Central Authority of the German Länder for Health Protection (opens in a new window) Coordinates GMP inspection across the German federal states. ZLG
· Document: DE
USA: FDA
- 21 CFR Part 211: cGMP for finished pharmaceuticals (opens in a new window) Current version in the eCFR. eCFR / U.S. Government
· Document: EN - 21 CFR Part 11: Electronic records and electronic signatures (opens in a new window) Current version in the eCFR. eCFR / U.S. Government
· Document: EN - 21 CFR Part 820: Quality management system regulation for medical devices (opens in a new window) Current version in the eCFR. eCFR / U.S. Government
· Document: EN - FDA guidance: Sterile Drug Products Produced by Aseptic Processing (opens in a new window) Guidance on aseptic processing (2004). U.S. Food and Drug Administration
· Document: EN - FDA guidance: Process Validation (opens in a new window) General Principles and Practices (2011). U.S. Food and Drug Administration
· Document: EN
International
- ICH Quality Guidelines (opens in a new window) Including Q7, Q9(R1) and Q10 in the original. ICH
· Document: EN - EMA: ICH Q9 Quality risk management (opens in a new window) The version applicable in the EU, with supporting documents. European Medicines Agency
· Document: EN - PIC/S: Publications (opens in a new window) GMP Guide PE 009 and the inspectorates’ aide-memoires. Pharmaceutical Inspection Co-operation Scheme
· Document: EN - WHO: Good Manufacturing Practices (opens in a new window) GMP guidelines of the World Health Organization. World Health Organization
· Document: EN - WHO: Temperature mapping of storage areas (opens in a new window) Technical supplement to TRS 961 Annex 9 with practical guidance on measuring points, duration and evaluation. World Health Organization
· Document: EN
Medical devices
Not linked are standards and works that require payment, such as ISO 14644, ISO 8573-1, ISO 13485, the European Pharmacopoeia (Ph. Eur.), GAMP 5 and the ISPE Good Practice Guides, for example “Controlled Temperature Chambers”. They are available from their publishers.
Links checked on 11 November 2026. The operators of the linked sites are solely responsible for their content.
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