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TR-54-6 Formalised Risk Assessments for Excipients

In Dec 2019, the PDA published its sixth report in the QRM series. This Technical Report on formalised risk assessments for excipients was written in collaboration with IPEC, the organisation that represents producers, distributers and users of pharmaceutical excipients. The report reflects the inputs of both parties.

Designed to assist with compliance with the Falsified Medicines Directive: the EC & PIC/s Guidelines on Formalised Risk Assessment For Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use; and the FDA Safety & Innovation Act; the report develops a risk assessment model based on ICH Q9 principles that can be applied throughout the supply chain.

It applies to all excipients used in drug products at all stages of the life cycle and considers the types of risks that might be presented. Written by industry experts in Risk Management and Supplier Quality Management and with real world examples, the report is an invaluable tool to best practice in this area. 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 report can be accessed for free by members of the PDA through the Technical Portal at . It can also be purchased at a reduced rate with membership. These are some of the advantages  of PDA membership. So join today!