EMA Calls for Documentation of Biologic Manufacturing Processes

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. Drugmakers 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.
International Pharmaceutical Regulatory Monitor