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现行 DOXPUB 11-0042-OQP-1.0
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2 to 8C Cold Room Operational Qualification Protocol 2至8C冷室操作鉴定协议
发布日期: 2004-08-01
设备验证协议,用于评估监控、维护、清洁和操作内置步入式冰箱的程序,该冰箱用于在2至8摄氏度的温度范围内储存GxP原材料和成品。还包括系统组件的功能验证,包括控制和警报,以及使用Kaye热验证器的温度映射。包括以下数据收集表格、OQ先决条件、SOP审查、功能测试、空冷室温度映射研究、动态温度映射先决条件和动态温度映射研究。有关此验证包中的其他文件,请参阅11- 0042-IQP-1.0、11-0042-IQR-1.0和11-0042-OQR-1.0。
An equipment validation protocol for evaluating procedures for monitoring, maintaining, cleaning and operating a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Also includes functional verification of system components, including controls and alarms, and temperature mapping using a Kaye thermal validator. Includes the following data collection forms, OQ Prerequisites, SOP Review, Functional Tests, Empty Cold Room Temperature Mapping Study, Dynamic Temperature Mapping Prerequisites, and Dynamic Temperature Mapping Study. For other documents in this validation package, see 11-0042-IQP-1.0, 11-0042-IQR-1.0, and 11-0042-OQR-1.0.
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