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 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. www.gmp-compliance.org/files/guidemgr/20171117-qa-guide-f-1536242149.pdf The following directive can be ordered by the address in the „Source/Publisher” category. In cases where you can order on the Internet, we have set up a hyperlink. 7 Quality agreements allow compassionate customers and suppliers to create a partnership between companies that ensures the definition of all quality requirements. AQs are legally binding agreements negotiated between customers and adjuvant providers. 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. Clear delineation of GMP responsibilities reduces or eliminates costly product quality issues resulting from poor communication and ensures that the customer meets their regulatory requirements and requirements. IPEC has updated IPEC`s 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 download on November 13, 2017 from the following sites: 9 In this guide, the terminology should and it is recommended does not mean necessary. Common sense should be used in the application of this manual. Purpose and scope Quality agreement is the set of quality management system requirements that must be met either by the supplier or by the customer, in order for the listed excipient to be manufactured in accordance with regulatory requirements or customer expectations. The objective of quality assurance is to define which part is responsible for the delineated quality activities and how quality problems are solved. The agreements aim to formalise the quality obligations between the parties in order to ensure that appropriate quality procedures are obtained. For more information, visit the IPEC website (www.ipec.org). IPEC Europe Members: DOWNLOAD THE REPORT IPEC Europe Non-members: PURCHASE THE REPORT 2 At the time of the letter, there are regional pharmaceutical industry associations such as America, Europe, Japan, China and India. The aim of IPEC is to contribute to the development and harmonization of international standards of assistance, the introduction of useful new excipients to the market, and the development of good practices and guidelines for excipients. IPEC is made up of three major interest groups; 1. Manufacturers and distributors who are considered suppliers in this document are manufacturers.
Note: As part of this manual, distributors may also be customers. 2. Pharmaceutical manufacturers designated as users. Part I – Risk Assessment for Adjuvant Manufacturers 10 1 2 page 5 of 9 Copyright 2017 The International Pharmaceutical Excipient Council The intent of this document is not to rewrite GMP requirements. QAs cannot replace the purpose and results of the supplier`s qualification elements, such as audit.B. Terms adopted This keyword section defines the relationship between the manufacturer, distributor, supplier and customer. These definitions are essential for understanding the language in the manual and for the use of its models.