T/SHQAP 006-2024 Digital traceability technology requirements for the entire process of pharmaceutical production and laboratory management

Scope

Main technical content: This document focuses on the quality control laboratories of pharmaceutical production enterprises and proposes technical requirements for digital traceability of corresponding digital systems, such as Laboratory Information Management Systems (LIMS). The content includes quality inspection processes and control elements such as sample management, task assignment, inspection and analysis, approval and release, reagent and control product management, stability evaluation, and environmental monitoring. The goal is to establish digital traceability in pharmaceutical production quality control laboratories to improve drug quality control and regulatory capabilities. With the widespread application of various business systems in the pharmaceutical production field, system integration, communication, storage backup, and operation and maintenance have also become management priorities, and corresponding traceability requirements have been proposed for these aspects.

Development Information

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