T/JXYXH 0001-2022 Active Group standards

T/JXYXH 0001-2022 Annual Report Guide for Product Quality Retrospective of Drug Manufacturing Enterprises

Publish Date: 2022-01-27 Implement Date: 2022-02-10 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/JXYXH 0001-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Integrated services in the fields of medicine, health, and labor protection

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2022-01-27

Implement Date: 2022-02-10

Scope

Main technical content: Through the formulation of the "Guide for Annual Report on Product Quality Review and Analysis", enterprises can conduct product quality review and analysis for all drugs produced according to their varieties, in order to confirm the stability of their processes and the applicability of current quality standards for raw materials and finished products, timely detect adverse trends, determine the direction of product and process improvement, and comprehensively control the stability, safety, and effectiveness of product quality through self-inspection of the effectiveness of product quality analysis. This provides a scientific basis for continuous improvement of product quality.