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.