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FDAnews Drug Daily Bulletin
May 22, 2012 | Vol. 9 No. 101
Process Validation Should Encompass Complete Lifecycle of Drug, EMA Says
Drugmakers should apply a lifecycle approach to process validation — tying together data on product and process development, the commercial manufacturing process and maintenance and consistency of the process during routine commercial production, according to the European Medicines Agency (EMA). Although companies can choose among a traditional approach, continuous process verification or a combination of the two, the agency appears to favor continuous verification when feasible.
International Pharmaceutical Regulatory Monitor
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