On march 21st 2015 the EU published new guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C 95/02). The manufacturing authorization holder should identify risk presented to quality, safety and function of each excipient. In addition, the excipient manufacturer’s risk profile should be determined using a gap analysis of the required GMP against the activities an capabilities of the excipient manufacturer. The data to support the gap analysis should be obtained through audits.

Read the full guideline:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C:2015:095:FULL&from=EN