International Pharmaceutical Regulatory Monitor
September 2012
| Vol.
40 No.
9
EMA’s Approach to Process Validation Moves Closer to U.S. FDA’s Stance
While drugmakers should prepare for the most far-reaching approach to process validation, the U.S. Food and Drug Administration’s (FDA) lifecycle approach, they should also be aware of upcoming guidance from the European Medicines Agency (EMA), an expert says.
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