Regulatory library
EudraLex Volume 4
EudraLex Volume 4 is the EU's guide to good manufacturing practice: its chapters, annexes and parts. The library tracks the index itself so that new or revised annexes are noticed when they are published.
ValDoc's library holds 4 provisions of EudraLex Volume 4. This page is guidance in our words. The regulation's own text governs.
Last updated
Thirty minutes. Bring one piece of equipment.
Provisions in ValDoc's library
EudraLex Volume 4 index: Annexes 3, 6–10, 12–14, 17, 21 and Part IV
EudraLex Volume 4 index: veterinary legal acts
EudraLex Volume 4 index: Chapter 4 and Annex 11, 2025 consultationDraft
EC 2025 consultation: draft Chapter 4, Annex 11 and Annex 22Draft
Other regulations
- ATEX Directive 2014/34/EU
- Directive 2000/54/EC
- EMA GMP questions and answers: nonsterile manufacture
- EMA Guideline on process validation for finished products
- EU GDP Guidelines 2013/C 343/01
- EudraLex Volume 4, Annex 1
- EudraLex Volume 4, Annex 2
- EudraLex Volume 4, Annex 11
- EudraLex Volume 4, Annex 13
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.