www.fdanews.com/articles/146740-ema-document-biologic-production-processes-to-get-trial-approval
EMA: Document Biologic Production Processes to Get Trial Approval
May 28, 2012
Drugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says. Companies should provide further details of in-process testing and criteria as the product moves forward and they gain greater process knowledge, according to a new guideline on quality documentation for investigational biologics.
Clinical Trials Advisor
Clinical Trials Advisor