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微生物实验室通则general operating for microbiology laboratory.doc

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微生物实验室通则general operating for microbiology laboratory.doc
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微生物实验室通则1.0 Purpose/目的To define and describe the steps necessary to ensure proper control of the microbiology laboratory, including equipment monitoring, handling of samples, nonconforming product and documentation and review.定义和描述针对合理控制微生物实验室的必要措施,包括 设备监测、 样品处理、不合格产品、文件及其审核。2.0 Scope/范围This procedure applies to all personnel involved directly with the microbiology laboratory and associated support personnel.本程序适用于所有直接涉及微生物实验室的人员以及相关辅助人员。3.0 Associated Materials/相关材料3.1 QA-LAB-041 Sampling and Testing of the Purified Water SystemQA-LAB-041 纯化水系统取样和检验3.2 QA-LAB-005 Handling of Microbiology Laboratory Waste QA-LAB-005 微生物实验室废弃物处理3.3 QA-LAB-011 General Laboratory ProcedureQA-LAB-011 实验室通则3.4 QA-LAB-023 Laboratory Investigation ProcedureQA-LAB-023 实验室调查程序3.5 FM-QA-00024 Test Report FM-QA-00024 检验报告3.6 FM-QA-00025 Data Sheet FM-QA-00025 原始记录3.7 FM-QA-00054 Micro Test Log FM-QA-00054 微生物检验登记表3.8 FM-QA-00043 Laminar Flow Bench/Biosafty Cabinet Operational FormFM-QA-00043 超净台/生物安全柜使用 记录3.9 FM-QA-00044 Instrument Temperature Record FM-QA-00044 设备温度记录3.10 FM-QA-00045 Autoclave Performance Check FormFM-QA-00045 高压灭菌器运行确认记录3.11 FM-QA-00125 Instrument Using LogFM-QA-00125 设备使用记录3.12 FM-QA-00047 Microbiology Lab Cleaning/Disinfection FormFM-QA-00047 微生物实验室清洁/消毒记录4.0 Responsibility/职责4.1 It is the responsibility of the analyst to ensure that the procedure is followed as written. 分析人员的职责是严格按照以下所写程序操作。4.2 It is the responsibility of the Microbiology Lab Supervisor to assess any deviations from the written procedure.微生物实验室主管的职责是评估任何来自所写程序的偏差。4.3 It is the responsibility of the Lab Manager to assess the competence of the analyst performing the test.实验室的职责是评估分析人员执行此程序的能力。5.0 Procedure/程序5.1 Wearing Apparel 着装5.1.1 Laboratory smocks must be worn whenever any microbiological activity is engaged. When going to the clean room in microbiology laboratory, must put on the sterile clothes.任何时候进行微生物操作都必须穿实验室工作服。当 进入微生物实验室洁净区时,必须要穿上无菌衣物。5.1.2 Non-steril
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