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《China Pharmaceuticals》 2018-18
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Defect Analysis and Improvement Suggestion of Simulation Test of Culture Media Fill

Mao Hong;Chongqing Center for Drug Evaluation and Certification;  
Objective To help the manufacturing enterprises and GMP inspectors understand the key points in simulated test of culture media fill and improve the defects to meet the requirements of regulations. Methods The problems and causes of defects involved in simulated test of culture media fill were found and analyzed in the GMP certification on-site inspection of aseptic drug manufacturers.Results and Conclusion Totally 378 defects related to simulated test of culture media fill were found. Higher frequency of defects were divided into seven aspects: personnel and training,program design,culture media and condition of culture,record missing,worst condition,interference design,deviation survey. The analysis of its performance and countermeasures will help to form the key points of simulated test of culture media fill.
【CateGory Index】: R95
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