T/JXYXH 0004-2023 Active Group standards

T/JXYXH 0004-2023 Drug marketing authorization holder/material management on-site inspection guide for pharmaceutical production enterprises

Publish Date: 2023-12-25 Implement Date: 2024-01-10 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 0004-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2023-12-25

Implement Date: 2024-01-10

Pages: 33 pages

Scope

Main technical content: The "Guidelines for On-site Inspection of Material Management of Drug Marketing Authorization Holders/Drug Manufacturing Enterprises" are based on the key points and risk points of material management of holders/drug manufacturing enterprises, and provide guidance on aspects such as material supplier management, material release, management of non-conforming materials, and special management of materials, forming a check guide to provide technical guidance for inspectors to conduct on-site inspections of material management of holders/drug manufacturing enterprises