Kaat Bracquiné, quality and regulatory affairs, Capsugel explains how to achieve compliance with the new EU guidelines for excipient GMPs.

Last year, the European Union published new guidelines (2015/C 95/02) that require the pharmaceutical industry to demonstrate appropriate excipient Good Manufacturing Practices (GMPs) through a formalised risk assessment. As of the implementation deadline in March 2016, pharmaceutical companies should have conducted these formalised risk assessments and have them available to EU regulatory inspectors.

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