EFPIA CALLS FOR MORE FLEXIBILITY IN EU GMP ADVICE ON QUALIFICATION AND VALIDATION

THE EUROPEAN Federation of Pharmaceutical Industries and Associations (EFPIA) has called for more flexibility in proposed revised European Union (EU) good manufacturing practice (GMP) guidance on qualification and validation. Europe’s pharma industry federation thinks this would encourage the use of new technologies and methods going forward.In its formal response to the European Commission, commenting on draft changes to the EU GMP guide, the EFPIA welcomed most of the reforms, but warned that “some of the detail is too prescriptive to allow other ...


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