超净工作台安装确认书

验证方案的批准Approval of the Validation Protocol

审核和批准了相关SOP、标准和日程表之后在下表签字Sign here after reviewing and approving the SOPs, standards and schedules

目录Table of Contents
1 通用说明和先决条件GENERAL INSTRUCTIONS AND PREREQUISITE 3
1.1 目的和范围OBJECTIVE AND SCOPE 3
1.2 设备或仪器描述EQUIPMENT/INSTRUMENT DESCRIPTION 3
1.3 主要组件列表MAJOR COMPONENTS LIST 3
1.4 术语和定义TERMS AND DEFINITIONS 4
2 责任RESPONSIBILITIES 4
3 文件DOCUMENTATION 5
3.1 完成本文件COMPLETION OF THIS DOCUMENT 5
3.2 文件列表QUALIFICATION DOCUMENTS LIST 5
4 公用设施要求UTILITIES REQUIREMENTS 6
4.1 公用设施列表UTILITIES LIST 6
5 列举需要检定的项目CALIBRATION ITEMS 6
6 安装、接线、安全和外观检查INSTALLATION, HOOKUP, SAFETY AND PHYSICAL INSPECTION 7
7 预防性维护和安全评估PREVENTIVE MAINTENANCE AND SAFETY ASSESSMENTS 7
7.1 预防性维护PREVENTATIVE MAINTENANCE 7
7.2 安全评估SAFETY ASSESSMENT 7
8 缺陷报告附件列表DEFICIENCY REPORT ATTACHMENTS LIST 7
9 批准 APPROVALS 8
9.1 临时批准INTERIM APPROVAL 8
9.2 最终批准FINAL APPROVAL 8

1          通用说明和先决条件General Instructions and Prerequisite

1.1        目的和范围Objective and Scope

通常一份方案包含以下方面The different aspects that a normal protocol would address are:

I.             主要组件列表Major Component List

II.          所需文件Required Documents

III.        公用系统需求Utility Requirements

IV.        检定Calibration

V.          安装、接线、安全和外观检查Installation, Hookup, Safety and Physical Inspection

VI.        预防性维护需要Preventive Maintenance Requirements

VII.     缺陷报告附件列表：一份显示安装确认过程中产生的缺陷报告和缺陷报告状态的列表

Deficiency Report Attachment List: a list of the deficiency reports produced during the Installation Qualification and their status.

VIII.   证明Certification

这份方案描述超净工作台，编号MEC-06-02的安装确认程序。这台设备安置于1410。This protocol will define the procedure to be followed for the installation qualification of theLaminar flow cabinet, No.:MEC-06-02. It is located in the1410.

1.2        设备或仪器描述Equipment/Instrument Description

此设备或仪器放置在细胞培养间，房间号1410。

The Equipment/Instrument located in room No1410ofcell culturelab.

1.3        主要组件列表Major Components List

1.4        术语和定义Terms and Definitions

关键缺陷-在关键缺陷项目被（解决）完成之前，验证工作不能签署通过。

Critical Deficiency ? Validation may not be signed off until the item is closed out.

非关键缺陷-验证工作可以签署通过，可是继续使用没有被缺陷影响的项目。

NonCritical Deficiency ? Validation may be signed off and (continued) use of the item is not impacted by the deficiency.

2          责任Responsibilities

批准执行方案Approval to Commence Execution of Protocol

验证负责人VD : _____________________ 日期Date:_______________________

3          文件Documentation

3.1        完成本文件Completion of this Document

本文件不可复制。所有数据都必须在原始文件或附加表格上完成。每份附加表格都必须签名和署日期。This document is not to be copied. All results must be completed on the original document or on supplementary records attached to this document. Each attachment must be signed and dated.

本文件提供的空格都必须填写，如果不需要填写或者不适用，应当在相应空格里说明。如果某个数字或空格不需要，划对角线标明不适用或填入NA。All spaces provided in the IQ document must be completed. If a result is not applicable or not required this should be stated in the space provided. If a number of spaces are not required, a diagonal line through all spaces with a Not Applicable sign may be used.

本文件用黑色笔填写This document must be completed in black pen only.

3.2        文件列表Qualification Documents List

确认人Verified by:__________________        日期Date:__________________

4          公用设施要求Utilities Requirements

4.1        公用设施列表Utilities List

确认人Verified by:__________________  日期Date:__________________

5          列举需要计量的项目Calibration Items

列举所有的需要检定的项目-分类为关键（需要校验）和非关键（仅列出）List all instrument and measuring devices ? categories into critical (under calibration) or not critical for indication only)

确认人Verified by:__________________  日期Date:__________________

6          安装、接线、安全和外观检查Installation, Hookup, Safety and Physical Inspection

确认人Verified by:__________________  日期Date:__________________

7          预防性维护和安全评估Preventive Maintenance and Safety Assessments

7.1         预防性维护Preventative Maintenance

确认是否有预防性维护方案和程序。

Verify that the Preventive Maintenance program and procedures are available.

□有Available    □没有Not Available

确认人Verified by: ________________   日期Date: ________________

7.2        安全评估Safety Assessment

确认是否需要安全评估，如果需要是否已经执行。

Verify that a Safety assessment is required and if so has been conducted

□需要Required                           □不需要Not required

□完成（如果需要）Completed (if required)        □有报告Report Available

确认人Verified  by: _____________________      日期Date: ________________

8          缺陷报告附件列表Deficiency Report Attachments List

一份显示安装确认过程中产生的缺陷报告和缺陷报告状态的列表。

List deficiency reports produced during the Installation Qualification and their status. Refer to attached detailed reports.

9          批准Approvals

9.1        临时批准Interim Approval

如果没有关键验证缺陷调查，就直接进行最终批准。如果有关键缺陷就暂停批准。如果有非关键缺陷存在就执行临时批准，但不能执行最终批准。

If there are no outstanding Critical Validation Deficiency Investigations go to final approval. If there are critical deficiencies withhold approvals. If the deficiencies are non-critical provide interim approval but not final approval.

9.2            最终批准Final Approval

执行最终批准，当所有的缺陷都已经解决和完成。Provide final approval when ALL deficiencies are resolved and closed out.

参与验证的人在签名记录表签名Include Sheet of signatures of those involved with the validation activity

签名记录表Signature Record

所有参与验证的人员在下表中签名以表明身份。All personnel involved in this qualification must complete the table below to provide identification of all the signatures/initials used in this document.

原文来源：http://www.icleanbench.com/