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.

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