摘要
目的分析我国疫苗生产用动物和动物源性材料质量要求与国外相关技术规范的差异,探索进一步提高和完善我国疫苗生产用动物和动物源性材料质量标准的途径。方法概述我国实验动物质量标准和局限性,将《中国药典》与国外相关技术法规对疫苗生产用动物和动物源性材料质量标准进行对比分析。结果与结论我国应研究制订达到或接近国际标准要求的疫苗生产用动物源性材料质量标准,保证疫苗质量和公众用药安全。
Objective To review and evaluate the quality requirements for animal and animal- originated material used for vaccine production in China and reveal the discrepancy between the standards and those of relevant international technological guidelines, thus exploring the means to improve quality standards of animal and animal-originated material used for vaccine production. Methods To make overview of the content and limitation for quality standards of laboratory animal in China, compare the Chinese Pharmacopoeia （ChP） with international guidelines in animal and animal-originated material quality requirement. Results and Conclusion The standards of animal-originated material for vaccine production which is consistent or close to international ones should be established, to ensure the vaccine quality and safety for the public.
出处
《中国药事》
CAS
2013年第8期794-797,804,共5页
Chinese Pharmaceutical Affairs
基金
国家科技支撑项目:实验动物新品种的种群建立与质量标准化研究(编号2011BAI15B01)
关键词
疫苗
动物源性材料
质量
安全
vaccine； animal-originated material； qualityl safety
