T/SHPPA 010-2021 Digital Quality Assurance Technical Requirements for Drug Production

Scope

Scope: This document specifies the technical requirements for digital quality assurance in pharmaceutical production, including establishing basic requirements, application functions, obtaining pharmaceutical production data, compliance management and early warning, implementation, risk management, and data formats and interfaces. This document applies to the digital design and practice of quality assurance-related activities during pharmaceutical production. Main technical content: By standardizing the construction and implementation of digital quality assurance technologies during pharmaceutical production, this document rationally utilizes digital technologies and tools to timely obtain data in standardized formats. By recording, evaluating, and reviewing the obtained data, it enhances the automation level of quality assurance, thereby promoting more reliable, compliant, accessible, collaborative, and accurate quality assurance work in pharmaceutical production. Digital quality assurance improves the quality assurance level of pharmaceutical production by monitoring errors, tampering, and neglect of key data affecting drug quality during the production process.

Development Information

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