T/SHQAP 002-2023 Digital traceability technology requirements for the entire process of pharmaceutical production and production manufacturing management

Scope

Main technical content: This document focuses on the workshop production and manufacturing of pharmaceuticals, and proposes technical requirements for digital traceability for corresponding digital systems, such as the Manufacturing Execution System (MES). The content includes the traceability and data integrity of key business processes in the system, such as production instructions, prescription management, quality management, material management, equipment status, and 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 widespread application of various business systems in the pharmaceutical production field, the integration, communication, storage backup, and operation and maintenance of the system have also become management priorities, and corresponding traceability requirements have been proposed for this purpose.

Development Information

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