T/CQAP 4001-2024 Active Group standards

T/CQAP 4001-2024 Guidance for Quality Risk Management Requirements and Implementation of Pharmaceutical Manufacturing Enterprises

T/CQAP 4001-2024 Guidance for Quality Risk Management Requirements and Implementation of Pharmaceutical Manufacturing Enterprises

Publish Date: 2024-03-14 Implement Date: 2024-06-14 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/CQAP 4001-2024
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Standardized management and general provisions
ICS Name: Other standards related to quality
Publish Date: 2024-03-14
Implement Date: 2024-06-14
Pages: 58 pages

Scope

This document stipulates the management requirements for the construction of a quality risk management system in pharmaceutical production enterprises in terms of organizational environment, organizational responsibilities, resource support, system planning, system operation, measurement, evaluation, and improvement. This document is applicable to the construction of quality risk management systems in pharmaceutical marketing authorization holders and pharmaceutical production enterprises. Other organizations involved in quality risk management can refer to and use it for reference.

Development Information

Word Count: 73 Thousand words Pages: 58 pages

Referenced Standards

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