质量安全与检验检测

通过能力验证，实验室对人员、设备、物料、方法、环境及检测等关键要素进行全面考察，有效提升了检验检测水平。实验室完成了4项微生物检验能力验证：中国食品药品检定研究院的NIFDC-PT-451化妆品中金黄色葡萄球菌检验、NIFDC-PT-441化妆品菌落总数计数、NIFDC-PT-446药品中霉菌和酵母菌总数计数，以及中国质量检验检测科学研究院测试评价中心的ACAS-PT1645(2023)药品中沙门菌检查。依据作业指导书、《化妆品安全技术规范》（2015版）第五章和《中国药典》2020年版四部通则1105、1106开展检验。结果显示，化妆品菌落总数计数和药品中霉菌和酵母菌总数计数，Z值均小于2。化妆品中金黄色葡萄球菌检验中，TC04510048未检出，用VITEK 2进行菌种鉴定为表皮葡萄球菌和弗氏柠檬酸杆菌；TC04510298检出，干扰菌为粪肠球菌。药品中沙门菌检查，23-C709未检出，23-D386检出。本次4项能力验证结果均为满意。通过多次的能力验证，人员实验技能得到提升，同时，对化妆品与药品微生物检验项目的异同点进行分析比较，总结能力验证经验，实验室整体检测能力得到明显增强。

Through capability verification,various aspects of laboratory personnel,equipont,materials,methods,environment,and testing were examined,improving the level of inspection and testing. The laboratory completed four microbiological testing capability verifications:the inspection of Staphylococcus aureus in cosmetics(NIFDC-PT-451),the inspection of total bacterial count in cosmetics(NIFDC-PT-441),the inspection of total mold and yeast count in drugs(NIFDC-PT-446) organized by the National Institute for Food and Drug Control,and the inspection of Salmonella in drugs(ACAS-PT1645) by Chinese Academy of Quality Inspection & Testing. According to the operation instructions,Chapter 5 of the Cosmetic Safety Technical Specification(2015 version),and General Rules 1105,1106 of the Chinese Pharmacopoeia(2020 version),conduct the inspection. The results showed that the Z-values for the total bacterial count in cosmetics and the total mold and yeast count in drugs were both less than 2. TC04510048 was not detected in the testing of Staphylococcus aureus in cosmetics,and was identified as Staphylococcus epidermidis and Citrobacter freundii using VITEK 2;TC04510298 was detected,and the interfering bacteria were Enterococcus faecalis. Salmonella was not detected in drug 23-C709,but detected in drug 23-D386.The results of the four capability verifications are all satisfactory. Meanwhile,by analyzing and comparing the similarities and differences between microbial testing projects for cosmetics and pharmaceuticals,and summarizing experience gained from capability verification,the overall testing capability of the laboratory has been significantly enhanced.