Regulatory library
EMA Guideline on process validation for finished products
EMA's guideline on process validation for finished products. It accepts traditional, continuous and hybrid approaches and expects the equipment behind them to be qualified first.
ValDoc's library holds 1 provision of EMA Guideline on process validation for finished products. 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
EMA Guideline on Process Validation for Finished Products (2016)
Guideline on Process Validation for Finished Products
Other regulations
- ATEX Directive 2014/34/EU
- Directive 2000/54/EC
- EMA GMP questions and answers: nonsterile manufacture
- 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
- 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.