This document focuses on the workshop production and manufacturing of pharmaceuticals, and proposes technical requirements for digital traceability for corresponding digital systems, such as manufacturing execution systems (MES). The content includes production instructions, prescription management, quality management, material management, equipment status and Traceability and data integrity for key operations such as production batch records. The goal is to improve the quality control of pharmaceutical production and the supervision of the pharmaceutical production process by establishing digital traceability of the pharmaceutical production process. With the popularization of the application of various business systems in the field of pharmaceutical production, system integration, communication, storage backup and operation and maintenance have also become the focus of management, and corresponding traceability requirements have also been put forward.
T/SHQAP 002-2023 history
2023T/SHQAP 002-2023 Technical requirements of digital traceability in the whole process of drug production——Manufacturing management