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.
One step up: achieving compliance for excipient GMPs