IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18

 

Inside this issue

     

IPEC Federation and PDA forge risk assessment alliance

IPEC Federation is pleased to announce its first joint initiative with the Parenteral Drug Association (PDA).

Both associations signed 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 an “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. This guide provides excipient suppliers with an overview of risk assessment tools, and resources that they can use, when conducting risk assessments required by both NSF/IPEC/ANSI 3631 and EXCiPACT excipient GMP standards.

Both PDA and IPEC Federation believe that presenting a common approach to the legal, regulatory and related issues concerning excipients is best presented as “one voice”, and so this joint initiative will deliver one technical document addressing the complex challenges of implementing risk assessment in this context. IPEC Federation sees much benefit in this collaboration bringing in IPEC’s excipient expertise from one side, and the drug product manufacturer perspectives through PDA.

For more information: Contact the IPEC Federation Secretariat
Email: info@ipec-federation.org

 

 

 

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