T/SHQAP 015-2024 Active
T/SHQAP 015-2024 Biological Product Manufacturing and Biosafety Management Guidelines
Abstract
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.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/SHQAP 015-2024 |
| ICS | Other standards related to pharmaceutics |
| Implement Date | 2024-08-08 |