IPEC Federation position on Pharmaceutical Excipients GMP Documents

Category: IPEC Federation
  • 29 Jun 2020

The International Pharmaceutical Excipients Council Federation (IPEC Federation) announces the availability of a new position paper titled “Pharmaceutical Excipients GMP Documents supported by the IPEC Federation”. 

This paper explains the purpose of the different good manufacturing practice (GMP) guides and standards available for excipients, and how they may be used. Excipient manufacturers can better understand the documents and decide which is the most appropriate to adopt for their purpose.

The Joint IPEC PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, EXCiPACT™ GMP Annex and NSF/IPEC/ANSI 363 excipient GMP standard are described, along with questions to help the excipient manufacturer select the document to align with. IPEC points out that an excipient manufacturer should implement a Quality Management System designed around one of the three, and monitor future developments so it is transparent to customers and auditors alike, which requirements are beign followed.  

The position paper is available for download immediately via the website www.ipec-federation.org.

For further information contact the IPEC Federation Secretariat at +32 2 213 74 40 or write to info@ipec-federation.org.

Read the document