Home » EMA Calls for Documentation of Biologic Manufacturing Processes
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
International Pharmaceutical Regulatory Monitor
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