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. 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. 8 IPEC is committed to facilitating communication between ancillary customers and suppliers using best practices. Best practices use the auxiliary manufacturer`s quality assurance system as the basis for the agreement. The IPEC QS models are designed to provide satisfied customers and suppliers with a common starting point to create quality agreements that are advantageous and consistent with both parties.
By using the IPEC QA model structure and retail, customers and suppliers reduce the time and time required to complete AQs. Changes can be made to the models to meet all the specific needs of the customer and supplier. 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. 9 This guide should and recommends that terminology does not necessarily mean. 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.