型凈化工作臺驗證方案

1、SW-CJ-2FD凈化工作臺驗證方案起 草 人：審 核 人：批 準(zhǔn) 人：起草部門：起草日期：審核日期：批準(zhǔn)日期：執(zhí)行日期：驗證小組會簽部門崗位簽名簽名日期頒發(fā)部門： 質(zhì)量部Copy ： 行政部 物供部 質(zhì)量部QA 質(zhì)量部QC 研發(fā)部 生技部 疫苗車間 分包裝車間 工程部 保安部 營銷部 財務(wù)部 變更記載：修訂號 批準(zhǔn)日期 執(zhí)行日期00變更原因及目的：建立驗證文件，并通過驗證證明所驗證對象有效、穩(wěn)定、可靠。目 錄驗證方案···············

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35、標(biāo)準(zhǔn)附件2：資料檔案確認(rèn)表附件3：安裝確認(rèn)記錄表附件4：運行確認(rèn)記錄表附件5：靜態(tài)塵埃粒子確認(rèn)記錄表附件6：靜態(tài)沉降菌確認(rèn)記錄表驗證方案1 概述凈化工作臺主要用于為試驗提供百級試驗環(huán)境，減少試驗過程中微生物污染的機(jī)率，為試驗檢測數(shù)據(jù)的準(zhǔn)確性提供重要的保障。因此必須對凈化工作臺進(jìn)行驗證，以確保該設(shè)備能提供一個長期穩(wěn)定的潔凈環(huán)境，確保檢驗數(shù)據(jù)的真實可靠。本方案規(guī)定了凈化工作臺的驗證方案及接受標(biāo)準(zhǔn)，依據(jù)是凈化工作臺的使用說明書和SW-CJ-2FD型凈化工作臺使用、維護(hù)保養(yǎng)標(biāo)準(zhǔn)操作規(guī)程2 目的對該設(shè)備進(jìn)行驗證，以確保該設(shè)備能提供穩(wěn)定的潔凈環(huán)境，確保檢驗數(shù)據(jù)的真實可靠。3 職責(zé)質(zhì)量部QC室：負(fù)責(zé)起草質(zhì)量部QC室凈化工作臺的驗證方案，報告及驗證實施。工程部：協(xié)助質(zhì)量部進(jìn)行凈化工作臺的驗證實施。驗證小組：負(fù)責(zé)驗證方案的實施、驗證方案與驗證報告的審核會簽。驗證管理員：負(fù)責(zé)對驗證過程進(jìn)行協(xié)調(diào)檢查。QC檢驗員：負(fù)責(zé)驗證中的取樣檢驗，測試檢驗數(shù)據(jù)，并出具準(zhǔn)確的檢驗報告。4 驗證內(nèi)容4.1 預(yù)確認(rèn)：見附件14.2 安裝確認(rèn)4.2.1 資料檔案：確認(rèn)內(nèi)容見附件2。4.2.2 安裝確認(rèn)：確認(rèn)內(nèi)容見附件3。4.2.3 儀表檢驗 塵埃粒子計數(shù)器由生產(chǎn)廠家進(jìn)行校驗。4.3 運行確認(rèn)4.3.1 目的4.3.1.1 對標(biāo)準(zhǔn)操作規(guī)程的適用性進(jìn)行確認(rèn)。4.3.1.2 檢查確認(rèn)系統(tǒng)運轉(zhuǎn)是否正常，并符合技術(shù)參數(shù)要求。對操作