PRESS RELEASE: Announcing the publication and availability of the revised IPEC Quality Agreement Guide November 2017

News category: 
Thursday, November 9, 2017

For Immediate Release:
Announcing the publication and availability of the revised IPEC Quality Agreement Guide in November 2017

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The IPEC Federation Quality Agreement Guide and Template(s) for Pharmaceutical Excipients 2017

The IPEC Federation has updated the IPEC Quality Agreement Guide, bringing the document fully in line with the latest thinking on requirements for pharmaceutical excipients. The updated guide will be officially available to download free-of-charge, on 13 November 2017 from the following websites:

With increasing regulatory and business demands, the relationship between excipient suppliers and pharmaceutical manufacturers, has never been so important. A mutual understanding of what is appropriate to ensure the safe and reliable supply of high quality excipients is essential and it is in the quality agreement that these expectations can be defined.

The concepts of what should be in such Quality Agreements have been explained in the 2009 IPEC Quality Agreement Guide and Templates. However, with new regulatory requirements and ever more complex supply chains, this Guide had been revised by a team of IPEC experts to provide practical and detailed guidance on how to meet all of these challenges. This new version considers EXCiPACT and ANSI certification standards, which are increasingly recognised as a means of demonstrating that suppliers operate in conformance with excipient GMP. And very significantly, to help ensure both final customers’ and manufacturers’ needs are addressed when the customer buys from a distributor, this revision introduces the innovative concept of Manufacturer’s Quality Statement template. IPEC 
believes this is a great step forward to enhance the integrity and security of excipient supply chain to achieve the overall goal of protecting patients.

The IPEC Federation is a global organization that promotes quality in pharmaceutical excipients. The IPEC Federation represents the five current regional International Pharmaceutical Excipient Councils (IPECs) - IPEC-Americas, IPEC Europe, IPEC Japan, IPEC China and IPEC India - and which provides a unified voice to promote the best use of pharmaceutical excipients in medicines as a means of improving patient treatment and safety.

Further details are available on The IPEC Federation’s website (www.ipec.org).