Home > Newsletters > International Pharmaceutical Regulatory Monitor > Process Validation Should Encompass Complete Lifecycle of Drug, EMA Says
International Pharmaceutical Regulatory Monitor
May 2012 | Vol. 40 No. 5
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). Includes the full text of EMA Draft Guideline On Process Validation for Drugmakers.
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