Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM. The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. Quality agreements are not only good business practices, but also regulatory requirements. ICH Industry Guide Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure that contract sites meet CGMP for certain operations. Written agreements should also set out considerations relating to subcontracting. They should describe how changes to processes, equipment, methods and specifications are managed and allow the owner to verify the owner`s compliance with CGMP. This guide describes the FDA`s current thinking on the definition, implementation and documentation of the manufacturing activities of the parties involved in the manufacture of contract drugs subject to the current requirements for good manufacturing practices (CGMP). In particular, we describe how parties involved in drug manufacturing can use quality agreements to define their manufacturing activities to ensure compliance with PMCs. The agreement should not include such elements as terms and conditions, pricing and stair terms, forecasts, delivery conditions, confidentiality obligations and liability limitations. These items are included in the delivery agreement, which is a separate document.
The quality agreement can be included in the reference supply agreement. If both documents are drawn up in one document, the authorization list may contain individuals who have no reason or time to check for problems that have nothing to do with their area of expertise. A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers.