PDA and IPEC Federation Publish Technical Report No. 54-6 Formalized Risk Assessment for Excipients 17 December, 2019

Bethesda, Md., / Brussels, Belgium – The Parenteral Drug Association (PDA) and the International Pharmaceutical Excipients Council Federation (IPEC) as an outcome of its collaboration established in March 2018, today announce the joint publication of a Technical Report for Formalized Risk Assessment for Excipients.

To comply with the European Commission Guidelines and PIC/S publication, excipients used in a drug product must be assessed for the risks that they pose to the drug product’s quality, safety, and purity. This requires drug manufacturers to ensure appropriate levels of GMP for excipients by using formalized risk assessments.

This joint PDA-IPEC Technical Report extends the PDA Technical Report No. 54 series on Quality Risk Management.

Highlights include:

• a model for quality risk assessment for excipients
• guidance on key GMP elements required for an excipient considering its source, supply chain and subsequent use
• a collection of actual examples from excipient users in the pharmaceutical industry

The Risk Assessment Technical Report is available:

1. To members of IPEC sister associations via their respective members’ areas and to members of PDA’s via its website, www.pda.org.
2. To purchase at https://www.pda.org/bookstore/product-detail/4405-tr-54-5-quality-risk-management