无菌过滤验证法规符合性质疑

【作者】 刘玉军； 梁毅；

【机构】 中国药科大学国际医药商学院；

【摘要】 目的研究当前制药行业通行的无菌过滤验证存在的不合理因素,提出改进的建议。方法通过对无菌过滤验证的分析和对FDA法规的研读,对无菌过滤验证的法规符合性提出质疑。结果与结论现行的无菌过滤工艺做法虽然未产生重大质量事故,但却有其内在的不合理因素,制药企业应更负责任的参与到验证中,提高无菌过滤工艺的无菌保证度。更多还原

【Abstract】 Purpose:By studying the inappropriate elements in current validation of sterile filtration, proposals for improving the practice are put forward.Method:Through analysis of the validation practice on sterile filtration and by study of FDA regulations,doubt is raised on the compliance of this approach Result & Conclusion:The present sterile filtration process,though without causing any serious quality events,has its inherent deficiency,but enterprises should be more responsibly involved in the validation of sterile filtration so as to enhance the sterile assurance level.更多还原