Ipec Quality Agreement Template

With increasing regulatory and commercial requirements, the relationship between aid providers and pharmaceutical manufacturers has never been greater. A mutual understanding of what is appropriate to ensure a safe and reliable supply of quality adjuvants is essential and these expectations can be defined in the quality agreement. The concepts that should be included in these quality agreements were explained in IPEC`s 2009 guide to quality agreements and documents. However, in light of new regulatory requirements and increasingly complex supply chains, this guide has been reviewed by a team of IPEC experts to provide practical and detailed guidance on how to address all of these challenges. This new version takes into account the EXCiPact and ANSI certification standards, which are increasingly recognized as a way to show that suppliers operate in accordance with the auxiliary GMP. And it is essential to ensure that the needs of end customers and manufacturers are taken into account when the customer buys from a distributor, this revision introduces the manufacturer`s innovative quality reporting model concept. IPEC believes that this is a major step forward in improving the integrity and security of the assistance supply chain in order to achieve the overall goal of patient protection. For more information, visit the IPEC website (www.ipec.org). The IPEC Federation is a global organization that promotes quality in pharmaceutical additives. The IPEC Federation represents the five current regional drug agencies (IPEC-Americas, IPEC Europe, IPEC Japan, IPEC China and IPEC India) and offers a unique voice to promote the best use of pharmaceutical aids in medicines as a means of improving patient treatment and safety. For immediate publication:Announcement in November 2017 of the publication and availability of the revised IPEC Quality Agreement Manual www.gmp-compliance.org/files/guidemgr/20171117-qa-guide-f-1536242149.pdf IPEC has updated the IPEC Quality Agreement Guide and has fully aligned the document with the latest reflections on pharmaceutical excipient requirements. The updated guide will be officially available for free on the following websites on November 13, 2017: Concepts of what should be included in the quality agreements have been explained in the IPEC Guide to Quality Agreements and Models 2009. However, in light of the new regulatory requirements and the complexity of supply chains, the guide was recently revised by a team of IPEC experts to provide practical and detailed guidance on current challenges.

IPEC Webinar Tuesday, February 13, 2018 – 11:00 a.m. The next directive can be ordered at the address listed in the “Source/Publisher” category. In cases where you can order on the Internet, we have set up a hyperlink.

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