The concepts that should be included in such quality agreements have been explained in the 2009 IPEC Guide and Model Quality Agreement. However, in light of new regulatory requirements and increasingly complex supply chains, this guide has been revised by an IPEC expert team to provide practical and detailed guidance to address all these challenges. This new version takes into account the EXCiPACT and ANSI certification standards, which are increasingly recognized as a way to demonstrate that suppliers are operating in accordance with the GMP adjector. And to ensure that the needs of end customers and manufacturers are taken into account when the customer buys from a dealer, this revision introduces the innovative concept of the manufacturer`s quality declaration model. IPEC believes that this is a major step forward in improving the integrity and security of the excipient supply chain in order to achieve the overall objective of patient protection. With increasing regulatory and business requirements, the relationship between excipient suppliers and pharmaceutical manufacturers has never been more important. A mutual understanding of what is appropriate to ensure the safety and reliability of the supply of quality auxiliaries is essential and the quality agreement can set these expectations. The IPEC Federation is a global organization that promotes the quality of pharmaceutical auxiliaries. The IPEC Federation represents the five International Regional Excipient Councils (IPECs) – IPEC-Americas, IPEC Europe, IPEC Japan, IPEC China and IPEC India – and offers a unique voice to promote the best use of medicines as a means to improve treatment and patient safety.
The IPEC Federation has updated the IPEC Quality Agreement Guide and has fully aligned the document with the latest thinking on pharmaceutical adipose requirements. The updated guide will be officially downloadable free of charge on 13 November 2017 on the following websites: IPEC Webinar Tuesday 13 February 2018 – 11:00 You can find more details on the IPEC Federation website (www.ipec.org). The following directive can be ordered via the address indicated in the “source/publisher” category. In cases where you can order on the Internet, we have set up a hypertext link. Immediate Publication:Announcement of the publication and availability of the revised IPEC Quality Agreement Guide in November 2017 Concepts to be included in quality agreements have been explained in the IPEC Quality Agreements 2009 Guide and Templates. However, given the new regulatory requirements and the complexity of supply chains, the guide was recently revised by an IPEC team of experts to provide practical and detailed guidance to address current challenges. www.gmp-compliance.org/files/guidemgr/20171117-qa-guide-f-1536242149.pdf. . .