Guide: Rx-360 Best Practices for Quality Agreements
This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. Generally, such agreements are between drug manufacturers and their material and service providers (i.e. manufacturers of APIs, excipients, packaging materials, etc. as well as providers of GxP services, analytical or other services to drug manufacturers. “Supplier” is used broadly in this document to refer to a company that provides materials, products, or services, including a sponsor. The quality agreement process can be one of the more time-consuming and back and forth efforts that Suppliers and Customers work through together. Extended negotiations, misunderstandings, and inflexibility frequently cause delays in the process, which can often take months and months to complete.
The guide aims to identify best practices, sample language, external references and resources, as well as common sense solutions to routine issues that come up during the quality agreement process. By providing perspective from both suppliers and manufacturers, the guide presents a balanced view designed to assist both parties in achieving a complete, concise agreement. Flexibility and compromise is needed in order to understand and work together to meet the requirements of both parties.
Using this Guide:
The guide is laid out in sections that replicate the process flow (see above) of implementing a Quality Agreement so that you can quickly browse to an appropriate section to review tips and best practices. Throughout this document, Best Practices and Tips are outlined in a red box. In addition to the guide itself, the included appendices offer a set of comprehensive tools to aid in developing a quality agreement program including:
- Content Regulatory References
- Sample Content Selection Matrix
- List of Industry Templates and Guides
It is the hope of the Supplier Led Working Group that this guide will help to facilitate a more efficient and effective quality agreement negotiation process. As with all of our other documents we have published we see this as a living document and we will update it as needed based on the most current industry and regulatory practices. We welcome any questions or comments you may have on the material in this document.