Joint PDA, IPEC TR Addresses Risk Assessments for Excipients

PDA’s latest technical report, Technical Report 54-6: Formalized Risk Assessment for Excipients, is a joint initiative between PDA and the IPEC Federation. This technical report provides guidance on quality risk management (QRM) principles that can be used to assess the risks to the quality, safety and function of an excipient in a drug product. The Technical Report provides practical guidance to be used in conjunction with existing regulatory and industry standards.

Technical Report No. 54-6 includes:

• Evaluations that can be used to provide an overall view of the risk question, “Is the excipient fit for use?”
• A generic risk assessment model and a holistic strategy applicable to excipient use for all dosage forms
• Discussion of end-to-end supply chain risks and information gathering
• Control strategy: benefits and challenges

Technical Report No. 54-6 is a response to 2015 European Commission guidelines on risk assessments for excipients. In 2018, PIC/S incorporated these same provisions for formalized risk assessment into a publication of the same name, extending the provisions to have global applicability. The technical report is grounded in the general principles outlined in ICH Q9: Quality Risk Management. Technical Report Series 54 is part of PDA’s collection of QRM-centered technical reports.

Technical Report 54-6: Formalized Risk Assessment for Excipients is available in the PDA Bookstore.