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1、方案第2版蒸汽消毒柜系統(tǒng)安裝確認方案（IQ）XXX藥業(yè)有限公司XXX藥業(yè)有限公司安裝確認方案名稱：蒸汽消毒柜系統(tǒng)方案號：PIQ013-2版本號：第2版共19頁第1頁生效日期：描述：蒸汽消毒柜系統(tǒng)安裝確認方案編寫人：日期：審閱人：日期:審閱人：日期:審閱人：日期:審閱人：日期:批準(zhǔn)人：日期:QA經(jīng)理最初方案批準(zhǔn)：頁總經(jīng)理日期：副總經(jīng)理日期：質(zhì)量保證部經(jīng)理日期：生產(chǎn)技術(shù)部經(jīng)理日期：機械動力部經(jīng)理日期：XXX藥業(yè)有限公司安裝確認方案名稱：蒸汽消毒柜系統(tǒng)方案號：PIQ013-2版本號：第2版共19頁第2頁目錄名稱
2、頁數(shù)1．目的··································································32．范圍··································································33．方案說明······························································34．系統(tǒng)描述····································
3、··························45．供應(yīng)商提供的技術(shù)文件··················································56．購買定單和發(fā)票························································67．工程圖紙······························································78．備用零件························
4、······································81．與物品接觸的材料······················································92．公用工程要求··························································103．報告··································································114．實地確認·····
5、·························································12A．設(shè)備·······························································12B．管道·······························································14C．儀表/裝置···················································
6、·······155．偏差表································································176．總結(jié)··································································187．最終方案審閱與批準(zhǔn)····················································19XXX藥業(yè)有限公司安裝確認方案名稱：蒸汽消毒柜系統(tǒng)方案號：PIQ013-2版
7、本號：第2版共19頁第3頁1．目的本方案的目的是用于驗證蒸汽消毒柜是根據(jù)相應(yīng)的說明書、圖紙安裝的。2．范圍本方案的范圍提供了檢查本系統(tǒng)的概要。本IQ應(yīng)表明：A．已安裝的設(shè)備符合工程設(shè)計圖紙和設(shè)備一覽表的規(guī)格。B．本系統(tǒng)/設(shè)備是根據(jù)設(shè)計圖紙和生產(chǎn)廠家設(shè)備說明書安裝的。C．備品備件清單完備且準(zhǔn)確，并且所有的操作、預(yù)防性維護等手冊完備。D．所有的安裝測試報告完備并保存于設(shè)備歷史檔案中。E．本系統(tǒng)符合現(xiàn)行的GMP要求。F．沒有事先批準(zhǔn)或有文件記錄的變更管理程序不得進行任何整改。G．所有與安全有關(guān)的內(nèi)容已形成文件。
8、3．方案說明A．盡可能詳細地填寫本方案中的所有表格。用墨水筆填寫。完成表格的人員應(yīng)在底部“核實人”一欄簽上姓名和日期。如果由一個以上的人填寫，那么每一個人都應(yīng)簽上姓名和日期。每一表格都應(yīng)由一個高層驗證小組人員進行審閱和簽字。B．方案執(zhí)行時可能會發(fā)現(xiàn)偏差。可能是由于與說明書、工程圖紙等不符而發(fā)生偏差。一旦這種情況發(fā)生，應(yīng)將一份“異常情況報告”送交驗證領(lǐng)導(dǎo)小組進行處理。C．驗證小組在驗證結(jié)束后應(yīng)做作出一份最終總結(jié)報告，并由華北XX
