超凈工作臺安裝確認書

驗證方案的批準Approval of the Validation Protocol

審核和批準了相關SOP、標準和日程表之后在下表簽字Sign here after reviewing and approving the SOPs, standards and schedules

目錄Table of Contents
1 通用說明和先決條件GENERAL INSTRUCTIONS AND PREREQUISITE 3
1.1 目的和范圍OBJECTIVE AND SCOPE 3
1.2 設備或儀器描述EQUIPMENT/INSTRUMENT DESCRIPTION 3
1.3 主要組件列表MAJOR COMPONENTS LIST 3
1.4 術語和定義TERMS AND DEFINITIONS 4
2 責任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 公用設施要求UTILITIES REQUIREMENTS 6
4.1 公用設施列表UTILITIES LIST 6
5 列舉需要檢定的項目CALIBRATION ITEMS 6
6 安裝、接線、安全和外觀檢查INSTALLATION, HOOKUP, SAFETY AND PHYSICAL INSPECTION 7
7 預防性維護和安全評估PREVENTIVE MAINTENANCE AND SAFETY ASSESSMENTS 7
7.1 預防性維護PREVENTATIVE MAINTENANCE 7
7.2 安全評估SAFETY ASSESSMENT 7
8 缺陷報告附件列表DEFICIENCY REPORT ATTACHMENTS LIST 7
9 批準 APPROVALS 8
9.1 臨時批準INTERIM APPROVAL 8
9.2 最終批準FINAL APPROVAL 8

1??????????通用說明和先決條件General Instructions and Prerequisite

1.1????????目的和范圍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.?????????????主要組件列表Major Component List

II.??????????所需文件Required Documents

III.????????公用系統(tǒng)需求Utility Requirements

IV.????????檢定Calibration

V.??????????安裝、接線、安全和外觀檢查Installation, Hookup, Safety and Physical Inspection

VI.????????預防性維護需要Preventive Maintenance Requirements

VII.?????缺陷報告附件列表：一份顯示安裝確認過程中產(chǎn)生的缺陷報告和缺陷報告狀態(tài)的列表

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

VIII.???證明Certification

這份方案描述超凈工作臺，編號MEC-06-02的安裝確認程序。這臺設備安置于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????????設備或儀器描述Equipment/Instrument Description

此設備或儀器放置在細胞培養(yǎng)間，房間號1410。

The Equipment/Instrument located in room No1410ofcell culturelab.

1.3????????主要組件列表Major Components List

1.4????????術語和定義Terms and Definitions

關鍵缺陷-在關鍵缺陷項目被（解決）完成之前，驗證工作不能簽署通過。

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

非關鍵缺陷-驗證工作可以簽署通過，可是繼續(xù)使用沒有被缺陷影響的項目。

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

2??????????責任Responsibilities

批準執(zhí)行方案Approval to Commence Execution of Protocol

驗證負責人VD : _____________________?日期Date:_______________________

3??????????文件Documentation

3.1????????完成本文件Completion of this Document

本文件不可復制。所有數(shù)據(jù)都必須在原始文件或附加表格上完成。每份附加表格都必須簽名和署日期。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須填寫，如果不需要填寫或者不適用，應當在相應空格里說明。如果某個數(shù)字或空格不需要，劃對角線標明不適用或填入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.

本文件用黑色筆填寫This document must be completed in black pen only.

3.2????????文件列表Qualification Documents List

確認人Verified by:__________________????????日期Date:__________________

4??????????公用設施要求Utilities Requirements

4.1????????公用設施列表Utilities List

確認人Verified by:__________________??日期Date:__________________

5??????????列舉需要計量的項目Calibration Items

列舉所有的需要檢定的項目-分類為關鍵（需要校驗）和非關鍵（僅列出）List all instrument and measuring devices ? categories into critical (under calibration) or not critical for indication only)

確認人Verified by:__________________??日期Date:__________________

6??????????安裝、接線、安全和外觀檢查Installation, Hookup, Safety and Physical Inspection

確認人Verified by:__________________??日期Date:__________________

7??????????預防性維護和安全評估Preventive Maintenance and Safety Assessments

7.1?????????預防性維護Preventative Maintenance

確認是否有預防性維護方案和程序。

Verify that the Preventive Maintenance program and procedures are available.

□有Available????□沒有Not Available

確認人Verified by: ________________? ?日期Date: ________________

7.2????????安全評估Safety Assessment

確認是否需要安全評估，如果需要是否已經(jīng)執(zhí)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)? ??????□有報告Report Available

確認人Verified? by: _____________________??????日期Date: ________________

8??????????缺陷報告附件列表Deficiency Report Attachments List

一份顯示安裝確認過程中產(chǎn)生的缺陷報告和缺陷報告狀態(tài)的列表。

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

9??????????批準Approvals

9.1????????臨時批準Interim Approval

如果沒有關鍵驗證缺陷調(diào)查，就直接進行最終批準。如果有關鍵缺陷就暫停批準。如果有非關鍵缺陷存在就執(zhí)行臨時批準，但不能執(zhí)行最終批準。

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????????????最終批準Final Approval

執(zhí)行最終批準，當所有的缺陷都已經(jīng)解決和完成。Provide final approval when ALL deficiencies are resolved and closed out.

參與驗證的人在簽名記錄表簽名Include Sheet of signatures of those involved with the validation activity

簽名記錄表Signature Record

所有參與驗證的人員在下表中簽名以表明身份。All personnel involved in this qualification must complete the table below to provide identification of all the signatures/initials used in this document.

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