Establishment and Application of Microbiological Supervision for Pharmaceutical Water in Manufacturers of High-risk Drug Based on Blind Sample Assessment
Establishment and Application of Microbiological Supervision for Pharmaceutical Water in Manufacturers of High-risk Drug Based on Blind Sample Assessment
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 Used 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 2 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.
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