环境分离菌在药品微生物检验中的应用

Application of In-house Microbial Isolates in Microbiological Tests of Pharmaceutical Products

目的:讨论环境分离菌在药品微生物检验中的应用。方法:通过对各国药典、法规、指导原则、行业标准和行业指南等文件的梳理和分析,列出了环境分离菌在药品微生物检验中的应用建议和要求,并结合实例,进一步介绍了环境分离菌的应用范围。结果:各国药典和行业指南均要求或建议在消毒剂效能验证、抑菌效力检查、培养基方法适用性(培养基促生长试验)、检验方法的适用性、快速微生物检验方法和微生物检验替代方法验证等检验项目中增加使用环境分离菌(包括生产检验过程中人员、环境以及样品中分离菌)。结论:与标准菌株相比,环境分离菌更能够反映样品或环境实际存在微生物的情况,因此,在药品微生物检验中应用环境分离菌能够使检验结果对产品质量或环境做出更客观和科学的评价。可根据检验项目、药品的生产工艺和产品本身的特点,在风险评估的基础上选择适当的环境分离菌应用于检验过程中。

Objective:To discuss the application of in-house microbial isolates in microbiological tests of pharmaceutical products.Methods:By combing and analyzing documents such as pharmacopoeia,regulations,guiding principles,industry standards and industry guidelines of various countries,the suggestions and requirements for the application of environmental isolates in drug microbiological testing were listed,and the application scope of environmental isolates was further introduced with examples.Results:Pharmacopeia and industry guidelines require or suggest that the use of in-house microbial isolates(including personnel,environment and isolated bacteria in samples during production tests)should be added to such inspection items as disinfectant challenge testing,antimicrobial effectiveness testing,suitability of culture medium(growth promotion tests),suitability of test methods,rapid microbiological methods and validation of alternative methods for microbiological testing.Conclusion:Compared with the standard strains,the actual microbial situation in the sample or environment could be refl ected by using in-house isolates.Therefore,the application of in-house isolates in microbiological tests can make a more objective and scientific evaluation of product quality or environment.According to the test items,the production process and the characteristics of the product itself,in-house isolates could be selected and applied to the microbiological test of pharmaceutical products based on risk assessment.