Rx 360 Quality Agreement Guide

The document follows a specific process flow from the perimeter and structure throughout the content of the verification and maintenance agreement. This helps the user navigate quickly to the necessary section. Best practices and advice are included in the process. In addition, the schedules offer a number of comprehensive tools, such as: the scope includes the manufacture and examination of FDA-regulated human and veterinary drugs, intermediate products, pharmaceutical active substances (APIs), auxiliary substances and raw materials essential to product quality. A new Rx-360 best practice guide has just been published. Rx-360 is a non-profit organization that supports the pharmaceutical and biotechnology industries to improve the safety of the pharmaceutical supply chain. It is managed by industry members, including manufacturers and suppliers. Your supplier-led working group developed a best practice guide for quality agreements and published it on the Rx-360 website. The aim of this guide is to “help customers and suppliers effectively manage the initiation, negotiation, implementation and day-to-day maintenance of quality agreements.” The aim is to facilitate a more efficient and efficient negotiation process for quality agreements. Quality agreements (QA) have become an essential tool for defining quality and regulatory responsibilities among participants in the pharmaceutical supply chain. Particularly in regulated environments, AQs are an essential part of the supplier`s qualification process.

These legally binding agreements are seen as one of the main pillars of a long-term business relationship between the parties. More recently, notified agencies and regulators have focused on this issue, particularly with respect to the subprocessed activities of the CGMP (p.B. FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs (2016)). All participants are encouraged to accept and follow these recommendations in order to make AQs a quality tool that benefits customers and suppliers. Chapter 7 of the EU GMP Guide on Outsourced Activities clearly sets out expectations for quality contracts.

Comments are closed.