Co., Ltd. 气相色谱仪验证方案 Qu alification Protocol for Gas Chromatograph DOCUMENT : Page 1 of 31 气相色谱仪验证方案 Qu alification Protocol for Gas Chromatograph 本文件须经过有限公司授权方能复印! This document cannot be duplicated without a Hunan DongtingPharm.Co.Ltd. Authorization Co., Ltd. 气相色谱仪验证方案 Qualification Protocol for Gas Chromatograph DOCUMENT : Pag e 2 o f 31 REVIEW AND APPROVAL PAGE OF VALIDATION PROTOCOL REVIEW AND APPROVAL OF VALIDATION PROTOCOL Prepared by 起草人 Title 职务 Signature 签名 Date 日期 Reviewed by 审核人 Title 职务 Signature 签名 Date 日期 Approved by 批准人 Title 职务 Signature 签名 Date 日期 Co., Ltd. 气相色谱仪验证方案 Qu alification Protocol for Gas Chromatograph DOCUMENT : Page 3 of 31 目 录 TABLE OF CONTENTS 1. 验证目的(Pu rpose) .............................................................................................................................. 5 2. 引用标准(Reference Docu mentation) ................................................................................................. 5 3. 系统描述(Sy stem Description) ............................................................................................................ 5 4. 职责(Responsibilities) .......................................................................................................................... 6 4.1 检查者(Operator) ....................................................................................................................... 6 4.2 审核者(Reviewer) ...................................................................................................................... 6 4.3 负责人(Manager) ....................................................................................................................... 6 5. 验证的管理(Qu alification Management) .....................