|Download document||Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission|
|Status||draft: consultation open|
|Consultation start date||01/05/2014|
|Consultation end date||31/10/2014|
|Email address for firstname.lastname@example.org|
Guidance is provided on data requirements for process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. This guideline covers process evaluation and verification studies for the upstream and downstream process, in the context of a marketing authorisation application or a variation application if relevant.