IPEC Federation Publishes Position Paper on EU Risk Assessment Guidelines for Excipients (2015/C 95/02)

Problem statement

The IPEC Federation (IPEC) acknowledges and welcomes the risk-based approach of the EU Guidelines1 following the principles of Quality Risk management according to ICH Q92. However, IPEC members acknowledges the limited jurisdiction of the EU Guidelines and recognizes that other Regulatory Agencies may view the specifics expressed in the EU Guidelines on Risk Assessment for Excipients differently. Therefore, this position paper applies only to the community regulated under the EU Risk Assessment Guidelines and is not intended to be commentary on risk assessment for other regions or in general. IPEC reserves the right to make additional or different comments on other laws, guidance, and publications as appropriate. The general principles are to properly control and track the quality and safety of excipients, throughout the entire supply chain, by appropriate means of quality management. This involves ensuring that Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) are implemented, in alignment with IPEC’s objectives and related guides and standards3. IPEC appreciates that many comments on the draft guidelines made by IPEC members have been considered in the final version.

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