Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (draft)
Title:
Eudralex Volume 3 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (draft)
Origin/Publisher:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This guideline addresses the data requirements for the validation of biotech manufacturing processes for submission of a marketing authorisation application or variation.