IPEC Federation has made its first joint initiative with the Parenteral Drug Association (PDA). Both associations inked a memorandum of understanding to collaborate on the development of a joint technical report on excipient GMP risk assessment in response to input from their respective memberships.
 
In March 2016, IPEC Europe published the ‘How-to document’ to help pharmaceutical manufacturers comply with the European Commission Guidelines on risk assessment for excipients (2015/C 95/02).

In May 2017 a joint IPEC-Americas and IPEC Europe Guide on risk assessment for excipient manufacturers followed. The guide provides excipient suppliers with an overview of risk assessment tools, and resources that they can use, when conducting audits that required by both NSF/IPEC/ANSI 3631 and EXCiPACT excipient GMP standards.
 
Both PDA and IPEC Federation opined that presenting a common approach to the legal, regulatory and related issues concerning excipients is best presented as ‘one voice’. In this regard, the joint initiative will deliver one technical document addressing the complex challenges of implementing risk assessment in this context.
 
IPEC Federation stated that it sees much benefit in this collaboration bringing in its excipient expertise to the fore and the drug product manufacturer perspectives through PDA.