摘要
目的分析我国药品无菌过滤验证中存在的缺陷,并提出相关的解决措施。方法从完整性检测、滤膜质量均一性及过滤验证的规范性三个方面,研究探讨无菌过滤工艺在验证与实施中的急需改进之处。结果与结论我国无菌过滤工艺在法规及行业实施中存在缺陷,药品生产企业及过滤器(膜)供应商应加强协作,监管当局应加强相关的立法与监督,使过滤工艺在实施中的缺陷得到纠正,降低无菌过滤的风险,确保药品的无菌。
Objective To analyze the deficiency in sterile filtration validation for drug production in China,and propose the related handling measures.Methods By focusing on integrity test,uniformity of membrane quality,and the conformity of filtration validation,this paper discusses the areas for improvement in the practice and validation of sterile filtration.Results and Conclusion There are deficiency in the regulation and industrial practice of sterile filtration of drugs.The drug manufacturers and suppliers of filters should strengthen their cooperation,and the regulators should establish the relevant regulations and supervision measures,so that the deficiency can be corrected to lower the risk of sterile production,and guarantee the sterility of drugs.
出处
《中国药事》
CAS
2010年第6期608-611,共4页
Chinese Pharmaceutical Affairs
关键词
无菌过滤
验证
完整性检测
生物负荷量
缺陷
sterile filtration
validation
integrity test
bio-burden
deficiency
