T/SHQAP 007-2024 Digital traceability requirements for the entire process of pharmaceutical production and warehousing management

Scope

Main technical content: This document focuses on the corresponding digital system (WMS) for storage management in pharmaceutical production enterprises, and proposes technical requirements for digital traceability. It mainly focuses on warehouse management operations and operations such as material and product inbound and outbound management, inventory management, status management, and acceptance management. It also makes relevant provisions on traceability information in the digital system. The goal is to enhance the level of storage control and traceability supervision by establishing complete traceability information items within the system. 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 requirements have also been put forward for this purpose.

Development Information

Related Standards