This document standardizes the construction and implementation of digital quality assurance related technologies in the pharmaceutical production process, rationally uses digital technologies and tools to obtain data in standardized formats in a timely manner, and improves the automation of quality assurance through the recording, evaluation and review of acquired data to promote Pharmaceutical production quality assurance work is more reliable, compliant, accessible, collaborative and precise. Digital quality assurance improves the quality assurance level of pharmaceutical production by monitoring errors, tampering, and neglect of key data that affect pharmaceutical quality during the pharmaceutical production process.
T/SHPPA 010-2021 history
2021T/SHPPA 010-2021 Technical requirements for digital quality assurance in pharmaceutical manufacturing