Regulatory library
EudraLex Volume 4, Annex 16
Annex 16 covers certification by a Qualified Person and batch release, which depends on the equipment behind each batch being qualified and in control.
ValDoc's library holds 1 provision of EudraLex Volume 4, Annex 16. 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 Annex 16 §§1.7.11–1.7.16
Effective
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.