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现行 DOXPUB 11-0042-IQP-1.0
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2 to 8C Cold Room Installation Qualification Protocol 2至8C冷室安装鉴定协议
发布日期: 2004-08-01
一份设备验证协议,用于评估、验证和记录内置步入式冰箱的安装和完整性,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。该协议包括11份设备、产品接触材料、采购和安装记录、认证文件、设备手册、,图纸、管道公用设施验证、电气公用设施验证、推荐备件以及关键和非关键仪器。IQ报告和OQ协议与报告的版本分别为11-0042-IQR-1.0、11-0042-OQP-1.0和11-0042-OQR-1.0。
An equipment validation protocol for assessing, verifying and documenting the installation and completeness of a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Includes 11 data collection forms for Equipment, Materials in Product Contact, Procurement and Installation Records, Certification Documents, Equipment Manuals, Drawings, Piped Utility Verification, Electrical Utility Verification, Recommended Spare Parts, and Critical and Non-critical Instruments. The IQ Report, and OQ Protocol & Report are available as 11-0042-IQR-1.0, 11-0042-OQP-1.0, and 11-0042-OQR-1.0.
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