氧化反应釜验证方案.docx

目录 Table of contents TOC \o 1-5 \h \z 设备基本情况 Overview 4 设备概述 Equipment description 4 设备主要技术参数 Equipment major technical parameters 4 设备安装图 Equipment installation drawings 5 维修服务情况 Maintenance service 5 2、验证目的 Acceptance criteria 6 确认厂家的技术资质、质量管理、制造是否符合使用者的要求 Qualify equipment manufacturing factory tsechnical qualificatio n\quality management\manufacturing comply with user requirements 6 确认该设备所有文件资料齐全，符合 GMP 要求 Qualify all equipments documents complete, comply with GMP requirement 6 确认该设备的各种仪器仪表经过校正合格 Qualify equipments instrumentations have been calibrated qualified 6 确认该设备所