Excipients: Final EU Guideline for formalized risk assessment ensuring appropriate GMP published
After a consultation period of about two years (the respective Draft guidelines have been published in 02/2013), the European Commission has published end of March the respective final EU GMP Excipient guideline (official title: “Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use”). The time frame for implementation of this guideline is listed with one year i.e. by 21 March 2016 excipients used in approved and marketed medicinal products must have been evaluated according to the guideline. The “Manufacturing authorisation holders should have the risk assessment/management documentation for appropriate GMP for excipients available on site for review by GMP inspectors.” according to the guideline.