T/SHQAP 015-2024 Active Group standards

T/SHQAP 015-2024 Biological Product Manufacturing and Biosafety Management Guidelines

T/SHQAP 015-2024 Biological Product Manufacturing and Biosafety Management Guidelines

Publish Date: 2024-07-09 Implement Date: 2024-08-08 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 015-2024
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Other standards related to pharmaceutics
Publish Date: 2024-07-09
Implement Date: 2024-08-08

Scope

Main technical content: This document is formulated in accordance with the provisions of the "Biosafety Law of the People's Republic of China", the "Regulations on Biosafety Management of Pathogenic Microorganisms in Laboratories", the "Good Manufacturing Practice for Pharmaceuticals", and the "General Requirements for Biosafety in Vaccine Production Workshops", etc., in order to meet the general needs of biosafety management in the production process of biological products in China. This document stipulates the requirements for establishing a biosafety management system for the production of biological products in terms of risk management, institutions and personnel, equipment and facilities, verification and evaluation, material management, laboratory management, safety management, biosafety, safety control, and continuous improvement, etc.

Development Information

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