某公司已過新版gmp認證潔凈廠房驗證模版-在線瀏覽
2024-07-28 05:08本頁面
【正文】 ***********公司口服固體項目車間的潔凈室（位號：*********** ）的安裝確認。安裝確認將確定直接影響系統的關鍵部件被正確地安裝，并符合設計文件需求；確定支持文件、質量文件在現場。1 / 27Clean RoomInstallation Qualification Protocol潔凈室安裝確認方案System No. 系統編號: CLR01Approval for Protocol 方案批準Company/Title公司/職務Name姓名Signature簽名Date日期Written by起草Reviewed by審核Approved by批準Revision 版本 Issued date 頒布日期 Reason for new issue 頒布原因REV. 00 Initial issue 首次發(fā)布2 / 27Index 目錄1. PURPOSE 目的 ...........................................................................................................................32. SCOPE 范圍 ................................................................................................................................33. RESPONSIBILITY 職責 ...............................................................................................................34. REGULATION AND GUIDANCE 法規(guī)和指南 .............................................................................35. ABBREVIATIONS 縮略語 ............................................................................................................46. SYSTEM DESCRIPTION 系統描述 ............................................................................................47. GOOD DOCUMENTATION PRACTICE 文件管理規(guī)范 ...............................................................58. TEST LIST 測試列表 ...................................................................................................................69. PERSONNEL IDENTIFICATION 人員確認 .................................................................................710. PROCEDURE 過程 .....................................................................................................................8 先決條件 ...........................................................................................................................8 文件確認 .........................................................................................................................10 圖確認 ............................................................................................................................11 房間組件檢查 .................................................................................................................14 儀器儀表校驗 ....
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