藥品微生物檢測實(shí)驗(yàn)室是藥品生產(chǎn)企業(yè)質(zhì)量控制的核心內(nèi)容之一，其質(zhì)量管理存在較大特殊性，因此從人員、設(shè)備、檢測相關(guān)物料、檢測方法、設(shè)施環(huán)境、檢測數(shù)據(jù)方面對藥品微生物檢測實(shí)驗(yàn)室質(zhì)量管理的要點(diǎn)、典型性缺陷舉例分析，為藥品生產(chǎn)企業(yè)、藥品檢測機(jī)構(gòu)提供參考借鑒。

Drug microbiological testing laboratory is one of the core contents of quality control in drug manufacturing enterprises, and its quality management has significant specificity. This article analyzes the key points and typical deficiencies cases of quality management in drug microbiological testing laboratories from the aspects of personnel, equipment, testing related materials, testing methods, facility and environment, and testing data, providing reference for pharmaceutical production enterprises and testing institutions.

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