無菌工藝模擬試驗的評估內(nèi)容涵蓋了無菌操作全過程，是對藥品生產(chǎn)活動無菌保證能力評估的有效方法，對其檢查的常見問題包括工藝模擬、報告與記錄、干預(yù)、模擬范圍、污染調(diào)查與處理、模擬的次數(shù)與頻次、模擬介質(zhì)（培養(yǎng)基）等方面。在對無菌工藝模擬試驗設(shè)計與方案制定、實施與執(zhí)行、持續(xù)評估與再驗證3個不同階段進行重點分析基礎(chǔ)上，就如何從程序文件規(guī)定、無菌工藝模擬試驗方案、無菌工藝模擬試驗報告與記錄、無菌工藝模擬試驗實施過程的視頻和相關(guān)記錄、生產(chǎn)現(xiàn)場情況、人員和關(guān)聯(lián)內(nèi)容等7個方面對無菌工藝模擬試驗的檢查重點進行了闡述。從藥品檢查角度對無菌工藝模擬試驗進行分析，就如何在無菌藥品檢查及各類自檢和外部審計中做好無菌工藝模擬試驗相關(guān)內(nèi)容的檢查進行研究，以期促進無菌工藝模擬試驗在藥品生產(chǎn)企業(yè)中更科學(xué)合理的開展，更好地保證藥品質(zhì)量。

The evaluation content of aseptic process simulation test covers the whole process of aseptic operation, which is an effective method to evaluate the sterility assurance ability of drug production activities. Common problems in the inspection of aseptic process simulation tests include process simulation, reporting and recording, intervention, simulation scope, contamination investigation and treatment, the number and frequency of simulations, simulation medium (culture medium), etc. Sterile process simulation test can be analyzed from three stages:design and program formulation, implementation and execution, and continuous evaluation and revalidation. Aseptic process simulation is evaluated from 7 aspects:procedure documentation, aseptic process simulation test plan, aseptic process simulation test report and record, video and related records of the implementation of aseptic process simulation test, production site conditions, personnel and related content. This article will analyze the aseptic process simulation test from the perspective of drug inspection, and elaborate on the inspection of relevant content in the sterile drug inspection, various self-inspection and external audit, hoping to promote the scientific and rational development of aseptic process simulation test in drug manufacturers, to better ensure the quality of medicines.

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