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. www.gmp-compliance.org/files/guidemgr/20171117-qa-guide-f-1536242149.pdf For more information, visit the IPEC Federation (www.ipec.org) website. 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 from the following websites on 13 November 2017: 7 quality agreements allow ancillary customers and suppliers to create a partnership between companies that will ensure that all quality requirements are defined. AQs are legally binding agreements negotiated between customers and ancillary suppliers. Quality agreements should be verified by quality services to ensure that all requirements are met and achievable. As a general rule, there should also be a legal review.
By clearly delineating GMP responsibilities, it is possible to reduce or eliminate costly product quality issues resulting from misunderstandings and ensure that the customer meets their regulatory expectations and requirements. 9 In this guide, terminology should and is recommended, does not mean that it must. Common sense should be used in the application of this guide. The purpose and scope of the quality agreement are all the requirements relating to the quality management system that must be fulfilled either by the supplier or by the customer, in order for the mentioned excipient to be manufactured in accordance with regulatory requirements or customer expectations. The goal of quality assurance is to define which party is responsible for delineated quality activities and how quality issues are solved. . . .