欧盟CGMP清洁验证方案.docVIP

XXXX片(lOmg规格〉清洁验证方案 Cleaning Validation Protocol of XXXX Tablets(lOmg) 方案起草 Prepared by 部门/岗位 Dept./Position 签名 Signature 起草日期 Date QA 年(Y)月(M)日(D) 方案审核 Reviewed by 部门/岗位 Dept./Position 签名 Signature 审核日期 Date QC主管 QC Supervisor 年(Y)月(M)日(D) QA主管 QA Supervisor 年(Y)月(M)日(D) 方案批准 Approved by 部门/岗位 Dept./Position 签名 Signature 批准日期 Date 质量保证部经理 QA Manager 年(Y)月(M)日(D) 颁发部门 Issued by QA 生效日期： Effective Date 分发部门 Distributed to 制造部(1份)、QC (1份) Production Dept.(l copy), QC (1 copy) 制作备份：2份 Copies prepared:2 pcs 目 录 Table of Contents TOC \o 1-5 \h \z HYPERLINK \l bookmark2 \o Current Document \h 清洁验证小组人 员名单/Team Member List 3 HYPERLINK \l bookmark4 \o Current Document \h 概述/General Introduction 4 HYPERLINK \l bookmark6 \o Current Document \h 2」本产品生产中使用的设备/Equipments used in the manufacturing 4 2.2本产品生产中使用的容器具 4 2.2Utensils used in the manufacturing 4 2.3本产品生产中使用的设备主要材质 5 2.3Construction materials contacting with drug product 5 HYPERLINK \l bookmark8 \o Current Document \h 》青；吉验个正目白勺/Purpose of cleaning validation 5 HYPERLINK \l bookmark10 \o Current Document \h 职责/Responsibility 6 HYPERLINK \l bookmark12 \o Current Document \h 制造部/Production Dept 6 4.2质量保证部/QA Dept 6 HYPERLINK \l bookmark18 \o Current Document \h d殳备动力 ^/Engineering Dept 7 HYPERLINK \l bookmark20 \o Current Document \h 5 .方 案的 执行/Execution of protocol 8 HYPERLINK \l bookmark22 \o Current Document \h 记录填 写要求/Filling of Raw Data 8 HYPERLINK \l bookmark24 \o Current Document \h 偏差、OOS/OOT 的调/Deviation, OOS/OOT investigation 8 HYPERLINK \l bookmark26 \o Current Document \h 5.3方案改变的控制程序/Change Control 8 HYPERLINK \l bookmark28 \o Current Document \h 清 洁验证 内容 Content of cleaning validation 9 HYPERLINK \l bookmark30 \o Current Document \h 清洁验证的准备工作 Preparation before cleaning validation 9 HYPERLINK \l bookmark32 \o Current Document \h 6.2XXXX 残留限度标准的设定 /Criteria of residual limit 12 HYPERLINK \l bookmark34 \o Current Document \h 取样程序及取样方法/Sampling procedure and method 13 HYPERLINK \l bookmark36 \o