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Guide: Best Practices for Quality Agreements Version 2.0

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply chain. Especially in regulated environments, QAs form a crucial part of the supplier qualification process. These legally binding agreements are considered one key pillar of a long-lasting business relationship between involved parties. Recently, the focus of notified bodies and regulatory agencies on this topic has increased, especially in connection to outsourced cGMP activities (e.g. FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs (2016)).

Since its original publication in 2015, the “Rx-360 Best Practices Guide for Quality Agreements” provides valuable advice and has been adopted by many key players in the industry. It provides tips and insights to efficiently initiate, negotiate, and maintain QAs. In light of ever-changing cGMP regulations and revised templates from industry committees, the Rx-360 Best Practices Guide was substantially enhanced and revised. It now reflects the most up-to-date perspective on this subject.

All stakeholders are invited to adopt and follow these recommendations, to make QAs a beneficial quality tool for customers and suppliers alike.