According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities with respect to CGMP compliance. The agreement should make it clear whether the owner or contracting body (or both) is engaged in certain CGMP activities. (1) Cooperation is essential for any successful business partnership, so it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization. Processes such as corrective and preventive measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. The guidelines also state that quality agreements should be clear with regard to product release. The ICH`s industry guide Q10 Pharmaceutical Quality System recommends that the owner, as a member of a pharmaceutical-grade system, ultimately be responsible for ensuring that “processes are in place to ensure control of outsourced activities and the quality of materials purchased.” It indicates that these processes involve quality management and should include critical activities, such as. B: The agreement must indicate controlled and documented changes that can be made by the contractor, only notification to the owner and those that must be discussed, verified and approved by the owner before they can be implemented. 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. iv. Manufacturing Activities – to document quality units and other manufacturing process activities, and to control changes in manufacturing processes To learn how to streamline the coordination of quality agreements and other manufacturing functions with digital tools, see the trend letter “3 Contract Ways Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration.” Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP.