Excipients serve a critical role in the production of final dosage forms for drug products and biologics as they help the product fulfil its purpose
(1). Recognizing this critical role, recent EU regulations require manufacturers to ensure appropriate levels of GMP for excipients by using
formalized risk assessments (2,3). As of March 21, 2016, excipient users/drug product manufacturers in the European Union are legally
mandated to have performed the needed assessments of excipient use and function throughout the entire supply chain.
In 2016, following an initial webinar, a team under the PDA Quality Risk Management Interest Group exchanged their experiences on
meeting this requirement. The group then surveyed other companies, finding that these companies have comparable questions. Different
solutions have been found in different companies, but similar principles apply.
The group has joined forces with IPEC, who in 2016 published a guide for excipient users on the subject (4). Now, this group and IPEC will
work together to produce a joint technical report. The group will form subteams for different specific topics. Volunteers working within these
subgroups will consist of representatives from both PDA and IPEC, and reflect manufacturers and suppliers. Volunteers interested in sharing their
company experience and working on the TR are welcome to join the group. Please contact PDA’s Volunteer Coordinator.
The technical report will provide examples of industry practices, and propose a generic solution. The document will serve as practical guidance
intended for use along with existing regulatory and industry standards. The technical report team expects that the document will enable manufacturers
and CMOs to either set up or benchmark their systems, and further establish collaboration with excipient suppliers and distributors.
- Holtz, F. “Establishing a Formalized Risk Assessment for Excipients.” PDA Letter
(January 2017) 53: 40–43.
- “Directive 2011/62/EU.” Official Journal of the European Union 54 (2011): 74-87.
- Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining
the appropriate good manufacturing practice for excipients of medicinal
products for human use (2015/C 95/02)
- March 18 2016, IPEC Europe “How to” document related to Guidelines of 19
March 2015 on the formalised risk assessment for ascertaining the appropriate
good manufacturing practice for excipients of medicinal products for human
use (OJ 2015/C 95/02)