药品微生物计数方法及方法适用性探讨

Discussion of the Microbiological Counting Method and the Suitability Test in Pharmaceutical Products

目的:探讨药品微生物计数方法及方法适用性试验,加强对方法适用性试验的理解。方法:分别从检验方法的选择、方法确认、中药制剂的特殊性以及实验过程等方面分析计数方法适用性试验。结果:药品微生物计数方法适用性试验必不可少,检验部门尚存在不足。结论:相关部门应重视微生物计数方法适用性,提高人员专业素质,加强质量控制。

Objective： To discuss the microbiological counting method and the suitability test in pharmaceutical products and strength- en the understanding of suitability test. Methods：Through analyzing the selection and confirmation of test methods, the particularity of tra- ditional Chinese medicine and the procedures of suitability test, to discuss the suitability test. Results：The suitability test in microbiological counting test is absolutely necessary. Inspection department is insufficient. Conclusion：Related departments should pay more attention to the suitability test of the microbiological counting method of pharmaceutical products, and improve the professional quality and quality con- trol in the meantime.