Eva Urban, Celgene, and Frithjof Holtz, Merck KGaA | Nov 05, 2018
Excipients serve a critical role in the production of final dosage forms for drug products and biologics as they help the product fulfill
its purpose (1). Recognizing this critical role, recent EU regulations require manufacturers to ensure appropriate levels of GMP for
excipients through application of formalized risk assessments (2,3). As of March 21, 2016, excipient users/drug manufacturers in the
European Union are legally mandated to perform needed assessments of excipient use/function throughout the entire supply chain.
A task force comprising representatives from both PDA and the International Pharmaceutical Excipients Council (IPEC) recently held
a face-to-face meeting in Berlin to discuss developing a PDA technical report on the topic. Some U.S. colleagues even took time out
of their evenings to phone in via Web conferencing.
In this meeting, representatives from pharma companies presented models for global solutions to introduce risk assessments for all excipients
(oral, parenteral, inhalation, etc.). These examples will serve as generic risk assessment models within the planned technical report.
The meeting also covered other hot topics, such as lifecycle management, complicated supply chains and benefits of the risk assessment.
A supply chain matrix will be included within the technical report that outlines the different responsibilities of all parties within the
supply chain, including brokers and contract manufacturing organizations.
The task force has completed a draft of the technical report’s overall framework. Now, the group has split into subgroups to work
on detailed sections and key topics, such as risk mitigation. Currently, the task force hopes to have the technical report published
sometime in Q1 of 2019.
Both PDA and the IPEC Federation believe that it is crucial to present “one voice” concerning the legal, regulatory and related issues
around excipients, so this joint initiative will deliver one technical document that addresses the complex challenges of implementing risk
assessments in this context. The IPEC Federation sees a great benefit in this collaboration, bringing in IPEC’s excipient expertise from
one side and the drug product manufacturer’s perspective through PDA.
- Holtz, F. “Formalizing a Risk Assessment for Excipients.” PDA Letter 53 (Jan
- European Commission. "Directive 2011/62/EU.” Off J Eur Union L 174 (2011): 74-87.
- European Commission. “Annex 1: Manufacture of Sterile Medicinal Products,
EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human
and Veterinary Use.” Nov. 25, 2008.