Regulatory library
EudraLex Volume 4, Part II
Part II is the EU's GMP guide for active substances, aligned with ICH Q7. It asks for equipment that is suited to its use, cleaned, calibrated and maintained, and for validated computerized systems.
ValDoc's library holds 4 provisions of EudraLex Volume 4, Part II. 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
EU GMP Part II §§4.20–4.34
Effective AUG2014
EU GMP Part II §§5.10–5.16;5.20–5.26
Effective AUG2014
EU GMP Part II §§5.30–5.35;5.40–5.49
Effective AUG2014
EU GMP Part II §§12.20–12.23;12.30;12.70–12.76
Effective AUG2014
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
- EudraLex Volume 4, Annex 1
- EudraLex Volume 4, Annex 2
- EudraLex Volume 4, Annex 11
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.