Regulations & Guidelines
Eudralex / EU Regulation
- EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
- EudraLex – Volume 4 – Annex 11 – Computerised Systems
- EudraLex – Volume 4 – Annex 15 – Qualification and Validation
- EudraLex – Volume 4 – Chapter 7 – Outsourced Activities
- EudraLex – Volume 4 – Glossary
- Good Distribution Practice (GDP) of medicinal products for human use
- Good Distribution Practice (GDP) for active substances for medicinal products for human use
- Questions and Answers on GDP
- Directive 2011/62/EU (English) – Falsified Medicines Directive (FMD)
- Commission delegated regulation (EU) 2016/161 of 2 October 2015 (English)
FDA (US Food & Drug Administration) Regulation
- 21 CFR Part 11 (eCFR) – Electronic Records; Electronic Signatures
- 21 CFR Part 11 – Electronic Records; Electronic Signatures — Scope and Application
- 21 CFR Part 210 (eCFR) – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- 21 CFR Part 211 (eCFR) – Current Good Manufacturing Practice for Finished Pharmaceuticals
- Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry – December 2018
- Current expectations and Guidance, including Data Integrity and Compliance with cGMP – June 2016
Microsoft GxP references
- Microsoft Azure GxP Guidelines (April 2018)
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