European Union: European Commission Issues New Guidelines On The Formalized Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients

On March 19, 2015, the European Commission issued new guidelines on risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. The risk assessment as set out in these guidelines should be carried out for excipients for authorized medicinal products for human use by March 21, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.