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Supplier Quality Agreement Medical Device

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In summary, SAQ agreements are not only the expected control method for high-risk suppliers, but can also offer clarity and smoother procedures for both the manufacturer and the supplier. The guide encourages owners to review and approve most changes before they are implemented. However, in certain circumstances, there are modifications that contractors can implement without notifying the owner. A quality agreement should indicate how all these changes are made and managed. In the eyes of the FDA, any activity that is not documented cannot have taken place either. A quality agreement offers the contractual entity and the owner the opportunity to define the expectations that verify and approve quality documents. It shall describe the minutes of changes to standard operating procedures (SIRs), manufacturing records, specifications, validation documentation and other essential documents relating to the goods or services provided by the contracting entity. The role of both parties in the production and maintenance of original DOCUMENTS in accordance with the PMFR or original copies should be clarified. The agreement should also specify how these recordings will be made available for consultation. It is beneficial to add a statement that electronic records are retained in accordance with CGMP and kept in an accessible condition during the necessary registration windows defined by the applicable rules in accordance with FDA requirements.

Distributors should have SAQ agreements, given that they are directly linked to the customer and that the extent of their responsibilities can have an impact both qualitatively and regulatoryly. For example, when action on the ground is necessary, it is important that a trader is cooperative and has the necessary information. In addition, devices that require installation and/or service and are often the responsibility of a dealer can have a significant impact on the safety and operation of a device. Outsourced processes are in turn part of the manufacturing process that you don`t directly control as a manufacturer. There are often processes where you can`t easily check if they have been executed correctly. In addition to process validation, SAQ agreements are a way to allow you to keep control of outsourced processes. As required by the above-mentioned guidelines, risk must be taken into account in the decision on the type of control for suppliers. High-risk suppliers and high-risk outsourced processes, such as sterilization, contract design and development, are examples of processes that are normally considered key or critical and would therefore expect quality agreements. The supplier`s quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP (Good Manufacturing Practice) obligations of the design owner and the supplier. A quality agreement is an important part of a supplier qualification program, but it does not replace supplier qualification processes (including audits if necessary) or understanding of the supplier, its processes and competencies.

A quality agreement should not contain commercial or liability terms that should only be addressed in a supply agreement. If a separate control laboratory is involved, all relevant roles and responsibilities must be defined. The quality agreement should explicitly specify what data is shared and how it is disseminated. Below is a list of things to include in an SAQ agreement with a supplier, as they apply to the specific task that the supplier pronounces. A quality agreement should indicate which party will define component specifications and which party will define processes for auditing, qualifying and monitoring component suppliers. . . .

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