Status and strategy of 3Rs principle application in quality control of biological products
10.13200/j.cnki.cjb.004279
- VernacularTitle:3Rs原则在生物制品质量控制中的应用现状及对策分析
- Author:
TANG Jing
- Publication Type:Journal Article
- From:
Chinese Journal of Biologicals
2024;37(8):1020-1024
- CountryChina
- Language:Chinese
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Abstract:
3Rs principle;Biological products;Supervision;Laboratory animals :Animal testing has always been an important part of the inspection and release of biological products including vaccines. In recent years,people have questioned the significance,requirements,methods and operations of animal testing by using animal method as the safety index of each batch of products. The principles of Replacement,Reduction and Refinement(3Rs for short)have been paid more and more attention since they were put forward. Based on the current situation of biological products supervision in China,this paper summarizes the application status of 3Rs principle in many national supervision systems,and the combing situation of using animals for testing in World Health Organization(WHO)guidelines on biological products by relevant experts in the world,aiming at promoting the implementation of 3Rs principle in quality control and batch release testing of biological products,and providing a reference for regulatory agencies and pharmaceutical industry to revise relevant contents in China.
