T/SHQAP 009-2024 Digital traceability technology requirements for the entire process of pharmaceutical production and quality management

Scope

Main technical content: This document specifies the general requirements for digital traceability in quality management in the digital traceability system architecture of the entire drug production process, including traceability content, traceability index, data management, and operation and maintenance. The core sections of traceability content mainly include change management, deviation management, corrective and preventive measures management, supplier management, audit management, release management, pharmacovigilance management, drug registration data management, confirmation and verification management, quality review management, complaint management, drug recall management, risk management, and contracted production management, etc.

Development Information

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