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FDAnews Drug Daily Bulletin
May 29, 2012 | Vol. 9 No. 105
EMA: Document Biologic Production Processes to Get Trial Approval
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.
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