基于盲样考核的高风险药品生产企业制药用水微生物质量管控模式的建立与应用

Establishment and Application of Microbiological Supervision for Pharmaceutical Water in Manufacturers of High-risk Drug based on Blind Sample Assessment

关键词:  制药用水  微生物限度  高风险药品生产企业  盲样考核  实验室比对

Key words:  pharmaceutical water  microbiological limit tests  pharmaceutical manufacturers of high-risk drug  blind sample assessment  inter-laboratory comparison

摘要:

目的 全面了解浙江省高风险药品生产企业制药用水微生物限度的检验能力,探讨基于盲样考核的高风险药品生产企业制药用水微生物质量监督新模式。方法 借鉴实验室比对和盲样考核的手段在浙江省范围开展实验室评估,数据分析采用稳健z比分数法和盲样特性制定评价原则。结果 共获得55家实验室总计165个检验结果,45家实验室获得满意结果,10家实验室结果偏离,7家偏离实验室结果负偏离,1家偏离实验室上报假阳性结果,2家企业两种偏离同时存在。结论 90%偏离实验室存在假阴性或数值偏低风险,日常水系统微生物监测数据可能数值偏低,不能有效发现制药用水的质量风险。30%偏离实验室存在微生物污染风险。可能存在样品污染、检测环境污染和无菌操作不规范等问题。基于盲样考核的微生物质量监督新模式可以助力企业提升微生物控制能力，确保药品质量安全。

Abstract:

OBJECTIVE To assess the supervision level of microbiological limit tests of pharmaceutical water in pharmaceutical manufacturers of high-risk drug in Zhejiang Province, and to explore a new microbiological supervision model of pharmaceutical water based on blind sample assessment. METHODS Using the methods of inter-laboratory comparison and blind sample assessment to evaluate the labs in Zhejiang province, and Robust Z-score method and blind sample characteristics were used to formulate evaluation principles for data analysis. RESULTS A total of 165 test results were obtained from 55 laboratories, 45 labs obtained satisfactory results, 10 labs got questionable results, 7 deviated labs reported negative results, 1 deviated lab reported false positive results, and two kinds of deviations existed simultaneously in 2 labs. CONCLUSION 90% of labs have the risk of false-negative or low value risk. The daily microbiological monitoring data of the water system may be relatively low, and the quality risk of pharmaceutical water cannot be effectively found. 30% deviated labs have microbial pollution risk. There may be problems such as sample pollution risk, environmental pollution risk and non-standard aseptic operation.The new microbiological supervision model based on blind sample assessment can help enterprises improve their microbial control capabilities and ensure drug quality and safety.