Static inspection and dynamic verification are two important aspects of a GMP quality management system. Static inspection refers to the checking and verification of compliance and quality control measures in the manufacturing process through non-real-time data such as documents, records and folders. Dynamic validation refers to the verification of product quality and compliance through real-time monitoring and testing of factors such as the environment, equipment and operations during the manufacturing process.
Static inspection and dynamic verification are therefore complementary and mutually reinforcing. Static inspection can detect and correct potential problems in advance, while dynamic validation can monitor all aspects of the production process in real time to ensure that the product meets quality standards. Therefore, in the GMP quality management system, static inspection through and can not replace the dynamic verification, both are necessary.
In summary, both static inspection and dynamic validation are necessary steps in GMP quality management system, static inspection is usually used to find potential problems, and dynamic validation is used for real-time monitoring and verification of product quality and compliance. Therefore, even after passing a static inspection, dynamic validation is still required.