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 to solve quality problems. The agreements aim to formalise the quality obligations between the parties in order to ensure that appropriate quality procedures are in place. 10 1 2 Page 5 of 9 Copyright 2017 The International Pharmaceutical Excipient council The intent of this document is not to rewrite GMP`s requirements. QAs cannot replace the purpose and results of supplier qualification elements, such as. B an audit. Principles adopted Keywords This section of keywords is used to define the relationships between the manufacturer, distributor, supplier and customer.
These definitions are essential to the understanding of the language in the manual and the use of its templates. For this reason, the following definitions are given. 1. Manufacturer The manufacturer of the adrequent; a party that performs the last stage of transformation. 8 IPEC is committed to facilitating communication between ancillary customers and suppliers using best practices. Best practices use the fuel manufacturer`s quality system as the basis for the agreement. The IPEC QA Templates has been designed to provide ancillary customers and suppliers with a common starting point for establishing mutually beneficial and regulatory compliant quality agreements. Through the use of the ipec QA Template and the degree of detail, customers and suppliers reduce the time and labor load required to achieve QAs.
Changes can be made to the templates to meet the specific needs of the customer and supplier. 7 Quality agreements allow ancillary customers and suppliers to establish 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. 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: the concepts that should be included in such quality agreements have been explained in the ipec Quality Agreement Guide and Templates 2009. 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 distributor, this revision introduces the innovative model concept for the manufacturer`s quality declaration. . . .