There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship. The scope of the quality agreement should include several compliance activities, such as qualification, calibration and maintenance of analytical tools and manufacturing equipment; Validation of computer systems, analysis methods and manufacturing processes; The specifications used to pass or fail to pass analytical tests Processing, storing and preparing; Receiving, analyzing and communicating samples Collecting and managing laboratory records Gap management and change control. Betty Lane has more than 20 years of experience in quality assurance and medical device regulation. It has implemented or updated quality systems for many small and medium-sized medical device and diagnostic companies. Their work allows companies to manage their operations in accordance with FDA and ISO 13485 requirements, allowing the sale of their products worldwide. Its background in the development of the digital system has enabled it to facilitate design controls and software validation when it has become FDA and industry requirements. A quality agreement should include at least the following sections: Supplier and supplier quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. The supplier quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and good manufacturing obligations (GMP) of the design owner and supplier.
A quality agreement is an essential part of a supplier qualification program, but it does not replace the supplier`s qualification processes (including audits when needed) or the supplier`s understanding of its processes and skills. A quality agreement must not include trade or liability conditions that should be dealt with exclusively in a supply contract. The quality agreement must be developed and mutually accepted by the CMO and the customer prior to the acceptance of the supply contract, in order to ensure the identification of all invoiced items and any capacity restrictions. Distributors should have SAQ agreements because they are directly linked to the customer and the extent of their responsibilities can have an impact on both quality and regulatory. For example, when action on the ground is required, 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 distributor can seriously affect the safety and operation of a device. Outsourced processes are again part of the manufacturing process that you do not directly control as a manufacturer.