T/SHQAP 001-2023 Active Group standards

T/SHQAP 001-2023 Guidelines for the establishment of a quality management system for pharmaceutical clinical trial sponsors

Publish Date: 2023-09-15 Implement Date: 2023-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHQAP 001-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Terminology (principles and coordination and cooperation)

Publish Date: 2023-09-15

Implement Date: 2023-10-15

Scope

Main technical content: (1) Scope: This standard provides guidelines for the construction of a quality management system for sponsors of drug clinical trials. (2) Normative reference documents: The normative reference documents of this standard include: GB/T 19000, Quality Management Systems – Fundamentals and Vocabulary. (3) Terms and definitions: Definitions of drug clinical trial quality, quality issues, etc. are provided. (4) Guidelines for the construction of a quality management system for sponsors of drug clinical trials: Guidelines are proposed in the aspects of policies, organization and systems, quality issue management, risk management, process management, product and/or service provider management, and continuous improvement. (5) References: Relevant laws, regulations, and normative documents referenced in this standard.