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1、WWW.HIGMP.COM GMP 爱好者 EXECUTION APPROVAL SIGNATURES 批准执行签名批准执行签名 The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requir
2、es the generation of an amendment which must be approved prior to execution. 下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标准进行的 任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。 *Company LTD:Date *:Date *:Date 1.0SCOPE: 范围范围.4 2.0PURPOSE: 范围范围.4 WWW.HIGMP.COM GMP 爱好者 3.0BACKGROUND: 背景背景.4 4.0INTRODUCTION: 介绍介绍 .4 5.0
3、REFERENCES: 参考书目参考书目.5 6.0RESPONSIBLE PARTIES AND RESPONSIBILITIES: 责任方及其责任责任方及其责任.7 7.0SYSTEM DESCRIPTION: 系统说明系统说明.9 8.0TESTING PROCEDURES: 测试程序测试程序.10 9.0ACCEPTANCE CRITERIA: 验收标准验收标准: .11 ATTACHMENT 1 - VALIDATION TEST EQUIPMENT AND MATERIALS附件 1确认测试设备和材料.13 ATTACHMENT 2 - SPECIFICATION AND PURC
4、HASE ORDER VERIFICATION附件 2规范和采购单确认.14 ATTACHMENT 3 - ENGINEERING DRAWING LIST附件 3工程图纸清单.15 ATTACHMENT 4 - STANDARD OPERATING PROCEDURES LIST附件 4标准操作程序清单.16 ATTACHMENT 5 - PREVENTIVE MAINTENANCE附件 5预防性维护 .17 ATTACHMENT 6 - OPERATION AND MAINTENANCE MANUAL LIST附件 6操作和维护手册清单.18 ATTACHMENT 7 - MAJOR CO
5、MPONENT LABELING LIST附件 7主要部件标签清单 .19 ATTACHMENT 8 - CRITICAL INSTRUMENT LIST附件 8关键仪器清单.20 ATTACHMENT 9 - NON-CRITICAL INSTRUMENT LIST附件 9非关键仪器清单.21 ATTACHMENT 10 - SPARE PARTS LIST附件 10备件清单.22 ATTACHMENT 11 - UTILITY DATA SHEET: ELECTRICAL附件 11公用工程数据表：电.23 ATTACHMENT 12 - UTILITY DATA SHEET: COMPRE
6、SSED AIR附件 12公用工程数据表：压缩空气.20 ATTACHMENT 13 - OPERATIONAL TESTING, TOC ANALYZER附件 13操作测试，TOC 分析器.241 ATTACHMENT 14 - ROM AND CONFIGURATION TEST附件 14ROM 和构造测试.262 ATTACHMENT 15 - MECHANICAL CHECK TEST附件 15机械检查测试 .29 ATTACHMENT 16 - FLOW TEST附件 16流量测试.31 ATTACHMENT 17 - LINEARITY/ SAMPLE MEASUREMENT TE
7、ST附件 17线性/样品测量测试.33 ATTACHMENT 18 - OPERATIONAL TESTING, TOC AUTOSAMPLER附件 18操作测试，TOC 自动取样.30 ATTACHMENT 19 - MECHANICAL TEST附件 19机械测试.41 ATTACHMENT 20 - SAMPLE TEST附件 20样品测试.43 ATTACHMENT 21 - SPARGE TEST附件 21喷射测试.44 ATTACHMENT 22 - MAGNETIC STIRRER TEST附件 22磁力搅拌器测试.45 ATTACHMENT 23 - SIGNATURE VERIFICATION LIST附件 23签名确认清单.36 ATTACHMENT 24 - PROTOCOL DEVIATION LOG附件 24文件偏差日志 .
