设 备 验 证 方 案 Equ ipment Qu alification Protocol 主题:201车间 S S L 6 0 0 三足式上卸料离心机IQ 验证方案 Title: Installation qu alification of GSHT-300 Coating machine in Plant 206 验证编号/Validation S.N.: 日期/Date: 设备编号/Equ ipment S.N.: 页数/total pages: 山 东 孔 府 制 药 股 份 有 限 公 司 SHANDONG PHARMACEUTICAL CO., LTD. 1 1. S S L 6 0 0 三足式上卸料离心机验证方案的审批 Review and approve validation protocol of the GSHT-300 coating machine 职能 Function 部门 Department 姓名 Name 签名 Signature 日期 Date 起草/Drafter 201车间/Plant 201 审核/Reviewer 201 车间/Plant 201 审核/Reviewer 201车间/Plant201 审核/Reviewer QA 审核/Reviewer 机械动力部 /Machine and Power Dep. 批准/Approval QA/quality assurance 批准/Approval 机械动力部 /Machine and Power Dep. 2. S S L 6 0 0 三足式上卸料离心机验证方案的历史修订记录/ GSHT-300 coating machine’s validation protocol revision history 版本 Version 日期 Date 方案修订者 Protocol revised by whom 批准人 Approval 修订说明 Revision description 2 目录 Contents 1、验证概述 Validation overview··························································· 3 2、验证小组成员及职责 Members of Validation team and their concerned responsibilities ························································································· 3 3、设备概述及工艺流程 Equipment overview and process flow ··········· 3 4、设备安装确认(IQ)Equipment installation qualification················ 4 4.1 安装确认内容 Installation qualification content ······························· 4 4.2 随机文件及附件确认 Documents with shipment and accessories qualification. ·····...