19/20 October 2021
In the EU GMP Guide Chapter 7 on Outsourced Activities, expectations regarding quality contracts are clearly defined. In the US, not much detail was provided so far. In 2013, the U.S. Food and Drug Administration (FDA) has published the draft Guidance for Industry "Contract Manufacturing Arrangements for Drugs: Quality Agreements". CFR regulations do not explicitly require contract partners to document their respective responsibilities in contract manufacturing arrangements, but the regulations do require that Quality Unit responsibilities and procedures are in writing (21 CFR 211.22(d)).
Now, a new Best Practice Guide has been published by Rx-360. Rx-360 is a non-profit organisation with the goal to support the pharmaceutical and biotech industry enhancing the security of the pharmaceutical supply chain. It is managed by members from the industry including both manufacturers and suppliers. Their Supplier-Led Working Group has developed a Best Practices for Quality Agreements Guide and published it on the Rx-360 website. The Intention of this Guide is "to assist both customers and suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements". The goal is to help facilitating a more efficient and effective quality agreement negotiation process.
The document follows a given process flow from scope and structure throughout the contents of the agreement to review and maintenance. This helps the user to quickly browse to the section needed, if necessary. Enclosed in the process flow are best practices and tips. In addition, appendices offer a set of comprehensive tools like, for example: