EN PL

EMA: Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

08.05.2014
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.