21 CFR, parts 820 and 211, provides that if the accuracy of instrument or instrument instruments and sensors is considered to be critical to the final efficacy, quality and safety of a regulated product or if it is likely to adversely affect the integrity of all prefabricated data or related data sets; The individual instrument must be considered a “critical instrument” (IC). A timetable-based recalibration plan must be developed to continuously verify the accuracy of all these measuring instruments. Trend analysis techniques should be used to determine that time is chosen between calibrations (TBC); ensures that a recalibration is planned well in advance of the accuracy of the instrument or sensor to compromise all pre-defined process parameters. In order to ensure the correct validation of a computerized system, all stages of the design, development, testing and routine use of the software must be monitored throughout the life cycle. Strict quality requirements in GMP-regulated sectors require specific controls and procedures throughout the software life development cycle (SDLC). Activities related to the application of appropriate controls and procedures throughout the SDLC and the development of the necessary documentation are all components of the technical discipline of computer system validation. Quality agreements are expressly requested by the EU and the FDA; If you are doing business in another region, it is a good idea to implement a quality agreement, even if it is not a regulatory requirement. Quality agreements are also defined in the ICH quality documents. ICH Q7, 16.12, “There should be a written and approved contract or formal agreement between a company and its contractors that specifies the responsibilities of PMPs, including quality measures, for each party.” The above items are included in the delivery agreement. The quality agreement should be a separate document from the delivery agreement, but can be added by reference.
Quality agreements and supply agreements are two very different documents. If created in a single document, the list of reviewers will contain many people on either side of the fence who have no real reason or time to check for problems that have nothing to do with their area of expertise. One of the most overlooked sections of the FDA`s #quality agreement guidelines is the definition section. It is important to know what any term means, especially for contracts with non-U.S. suppliers, says @MCMasterControl bit.ly/2DwrlEC “A quality agreement is a comprehensive written agreement between the parties who are involved in the manufacture of drugs that are defined and defines each party`s manufacturing activities with respect to how each is respected with CGMP.