While it is important to secure long-term care and maintain the current configuration of a component crucial to the design of your medical device, the process can become a little more complex. Typical components that can be checked are those that are exclusively intended for the performance or safety of your medical device. A supplier quality contract or delivery contract may be required. 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. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. Effective supplier management can help prevent problems and reduce their impact if they occur. With a greater focus on supplier management, you can expect strong coverage of this area during an FDA inspection. The FDA Quality System (QSR) Regulations explain how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. A common approach uses a supplier quality agreement. I recommend that a supplier quality contract be put in place at the beginning of the development process.
Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier. The guidelines encourage homeowners to verify and approve most changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. 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. In the eyes of the FDA, any activity that is not documented may as well not have occurred. A quality agreement gives the contracting establishment and the owner the opportunity to define the expectations of those who verify and approve quality documents.