分析儀器及其輔助系統(tǒng)影響性評估表

分析儀器及其輔助設備系統(tǒng)影響性評估,,,,,,,,,,,,,,,,,,,,

影響評估問題,,,,,,,,,,,,,,,,,,,,

1,儀器或儀器產生的數(shù)據(jù)是否直接影響所做出的關于產品本身或產品質量、純度、效價的決策？,,,,,,,2,該儀器是否具有測量性能？,,,,,,,,,,,

3,該儀器是否在購買后進行用戶校準？,,,,,,,4,該儀器是否測量數(shù)值或者控制物理參數(shù)？,,,,,,,,,,,

5,該儀器的使用是否采用觀察法以外需要更多其他方式？,,,,,,,6,是否具有一個單獨的計算機用以控制儀器或者數(shù)據(jù)采集？,,,,,,,,,,,

上述6個問題按順序分階段回答，以“Y”或“N”表示。若問題1回答是“N”，確認和驗證是沒有必要的，因為該項目對GMP無影響，在GMP影響性一欄填寫“N”。若2～4問題的所有回答都是“N”，判定為A類儀器，在判定類型一欄填寫“A”。若2～4問題的答案有一個是“Y”，則進行下一階段的評估。若5～6問題有任何回答是“N”，則判定為B類儀器，在判定類型一欄填寫“B”。若5～6問題所有答案都是“Y”，則判定為C類儀器，在判定類型一欄填寫“C”。,,,,,,,,,,,,,,,,,,,,

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分析儀器風險評估表,,,,,,,,,,,,,,,,,,,,

序號,系統(tǒng)名稱,系統(tǒng)編號,儀器/設備編號,安裝位置,使用目的,問題,,,,,,GMP影響性,判定類別,URS,安裝確認,運行確認,性能確認,校準,"預防性

維護保養(yǎng)",備注

,,,,,,1,2,3,4,5,6,,,,,,,,,

,十萬分之一天平01,,,,用于樣品制備,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,十萬分之一天平02,,,,用于樣品制備,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,萬分之一天平01,,,,用于樣品制備,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,萬分之一天平02,,,,用于樣品制備,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,萬分之一天平03,,,,用于樣品制備,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,千分之一天平01,,,,用于樣品制備,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,千分之一天平02,,,,用于稱重,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,Y,

,天平打印機01,,,,用于稱量數(shù)據(jù)打印,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,天平打印機02,,,,用于稱量數(shù)據(jù)打印,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,紫外分光光度儀,,,,用于樣品含量測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,可見分光光度計,,,,用于樣品透光度測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,全自動水分測定儀,,,,用于樣品水分測定,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,Y,

,浮游菌儀01,,,,用于環(huán)境監(jiān)控,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,調試

,浮游菌儀02,,,,用于環(huán)境監(jiān)控,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,調試

,細菌菌落計數(shù)儀,,,,用于環(huán)境監(jiān)控,Y,Y,N,N,N,N,Y,B,N,Y,Y,N,Y,Y,

,漩渦混合器01,,,,用于內毒素樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,漩渦混合器02,,,,用于內毒素樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,數(shù)顯鼓風干燥箱01,,,,用于細菌內毒素樣品干燥,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,數(shù)顯鼓風干燥箱02,,,,用于干燥失重樣品干燥,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,真空干燥箱,,,,用于樣品干燥失重,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,酸度計01,,,,用于pH測定,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,酸度計02,,,,用于pH測定,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,生物顯微鏡,,,,用于微生物鑒別,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,偏振光顯微鏡,,,,用于樣品性狀檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,塑料袋封口機（腳踏）01,,,,用于取樣樣品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,塑料袋封口機（腳踏）02,,,,用于取樣樣品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,鋁箔袋封口機01,,,,用于取樣樣品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,鋁箔袋封口機02,,,,用于取樣樣品封口,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,集菌儀01,,,,用于樣品無菌檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,集菌儀02,,,,用于樣品無菌檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,集菌儀03,,,,用于樣品無菌檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,生化培養(yǎng)箱（帶打?。?1,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培養(yǎng)箱（帶打?。?2,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培養(yǎng)箱（帶打?。?3,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培養(yǎng)箱（帶打?。?4,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培養(yǎng)箱（帶打?。?5,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培養(yǎng)箱（帶打?。?6,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,生化培養(yǎng)箱（帶打?。?7,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培養(yǎng)箱（帶打?。?1,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培養(yǎng)箱（帶打?。?2,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培養(yǎng)箱（帶打?。?3,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,霉菌培養(yǎng)箱（帶打?。?4,,,,提供微生物培養(yǎng),Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,微生物限度檢測系統(tǒng)01,,,,提供微生物限度檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,微生物限度檢測系統(tǒng)02,,,,提供微生物限度檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,超凈工作臺01,,,,提供微生物檢測潔凈環(huán)境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,超凈工作臺02,,,,提供微生物和檢測潔凈環(huán)境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,超凈工作臺03,,,,提供微生物檢測潔凈環(huán)境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,超凈工作臺04,,,,提供無菌檢測潔凈環(huán)境,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,臺式超聲波清洗器01,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,臺式超聲波清洗器02,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,數(shù)字電導率儀01,,,,用于電導率測定,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,數(shù)字電導率儀02,,,,用于電導率測定,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,穩(wěn)定性試驗箱（帶報警）01,,,,用于樣品穩(wěn)定性試驗,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,穩(wěn)定性試驗箱（帶報警）02,,,,用于樣品穩(wěn)定性試驗,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,穩(wěn)定性試驗箱（帶報警）03,,,,用于樣品穩(wěn)定性試驗,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,穩(wěn)定性試驗箱（帶報警）04,,,,用于樣品穩(wěn)定性試驗,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,穩(wěn)定性試驗箱（帶報警）05,,,,用于樣品穩(wěn)定性試驗,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,藥品強光照射試驗箱,,,,用于樣品穩(wěn)定性試驗,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,壓縮空氣檢測儀,,,,用于壓縮空氣檢查,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,恒溫水浴鍋(8孔),,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,恒溫水浴鍋(4孔)01,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,恒溫水浴鍋(4孔)02,,,,用于細菌內毒素樣品制備,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,澄明度檢測儀01,,,,用于樣品可見異物檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,澄明度檢測儀02,,,,用于樣品可見異物檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,澄明度檢測儀03,,,,用于樣品可見異物檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,澄明度檢測儀04,,,,用于樣品可見異物檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,旋片式真空泵01,,,,用于溶液過濾,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,旋片式真空泵02,,,,用于溶液過濾,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,隔膜真空泵01,,,,用于溶液過濾,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,隔膜真空泵02,,,,用于溶液過濾,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,電動吸引器,,,,用于微生物樣品檢測,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,電動吸引器,,,,用于微生物樣品檢測,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,

,生物安全柜,,,,用于菌種傳代,Y,N,N,Y,Y,N,Y,B,Y,Y,Y,Y,Y,Y,

,生物安全柜,,,,用于陽性對照,Y,N,N,Y,Y,N,Y,B,Y,Y,Y,Y,Y,Y,

,振實密度測試儀,,,,用于樣品密度檢查,Y,Y,N,Y,N,N,Y,B,N,Y,Y,N,N,N,

,旋光儀01,,,,用于樣品比旋度檢查,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,旋光儀02,,,,用于樣品比旋度及效價檢查,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,電阻爐01,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,電阻爐02,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,熔點儀,,,,用于樣品熔點檢測,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,超純水機,,,,用于實驗室超純水制備,Y,N,N,Y,Y,N,Y,B,N,Y,Y,Y,N,Y,

,西林瓶數(shù)顯偏光應力儀,,,,用于內包材檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,圓跳動測試儀,,,,用于內包材檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,壁厚測厚儀,,,,用于內包材檢查,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,電子秤（百分之一）01,,,,用于稱重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,電子秤（百分之一）02,,,,用于稱重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,電子秤（百分之一）03,,,,用于稱重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,電子秤（百分之一）04,,,,用于稱重,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,Y,

,微波爐,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,電磁爐01,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,電磁爐02,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,紅外可控調溫電爐01,,,,用于加熱,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,紅外可控調溫電爐02,,,,用于加熱,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,紅外可控調溫電爐03,,,,用于加熱,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,單門立式冷柜01,,,,用于樣品存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,單門立式冷柜02,,,,用于試劑存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,單門立式冷柜03,,,,用于試劑存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,雙門立式冷柜,,,,用于對照品存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,四門立式冷柜,,,,用于培養(yǎng)基存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,臥式冷柜01,,,,用于培養(yǎng)基等存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,臥式冷柜02,,,,用于試劑存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,低溫冰箱,,,,用于檢定菌存放,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,冰箱01,,,,用于溶液試劑放置,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,冰箱02,,,,用于溶液試劑放置,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,N,

,純蒸汽滅菌柜01,,,,用于潔凈物品滅菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,純蒸汽滅菌柜02,,,,用于潔凈物品滅菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,純蒸汽滅菌柜03,,,,用于潔凈物品滅菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,純蒸汽滅菌柜04,,,,用于潔凈物品滅菌,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,壓力蒸汽滅菌柜,,,,用于廢物滅活,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,過氧化氫滅菌柜,,,,用于取樣間物品消毒,Y,N,Y,Y,Y,N,Y,B,N,Y,Y,Y,Y,Y,

,檢驗隔離器01,,,,用于產品無菌檢驗,Y,N,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,檢驗隔離器02,,,,用于產品無菌檢驗,Y,N,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,取樣隔離器01,,,,用于無菌樣品取樣,Y,N,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,全自動高效液相色譜儀01,,,,用于樣品含量和雜質測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,全自動高效液相色譜儀02,,,,用于樣品含量和雜質測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,手動高效液相色譜儀03,,,,用于樣品含量和雜質測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,手動高效液相色譜儀04,,,,用于樣品含量和雜質測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,氣相色譜儀01,,,,用于殘留溶劑測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,氣相色譜儀02,,,,用于殘留溶劑測定,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,動態(tài)試管檢測儀,,,,用于內毒素檢測,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,TOC總有機碳分析儀,,,,用于注射用水檢測,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,自動永停滴定儀01,,,,用于樣品含量檢測,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,百特粒度激光儀,,,,用于粒度檢測,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,紅外光譜儀,,,,用于樣品鑒別,Y,Y,Y,Y,Y,Y,Y,C,Y,Y,Y,Y,Y,Y,

,紅外壓片機,,,,用于紅外樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,紅外線快速干燥器,,,,用于紅外樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,不溶性微粒儀,,,,用于樣品微粒檢測,Y,Y,Y,Y,Y,N,Y,B,N,Y,Y,N,Y,N,

,離心機01,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,三用紫外儀,,,,樣品TLC檢測,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,調試

,振蕩器,,,,用于樣品制備,Y,N,N,N,N,N,Y,A,N,N,N,N,N,N,調試

,培養(yǎng)基專用恒溫箱,,,,用于培養(yǎng)基培養(yǎng),Y,N,N,N,N,N,Y,A,N,N,N,Y,Y,Y,

,密封測試儀,,,,鋁蓋密封性檢測,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,密封測試儀,,,,鋁蓋密封性檢測,Y,N,N,N,N,N,Y,A,N,N,N,N,Y,N,

,完整性檢測儀01,,,,濾芯完整性檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,完整性檢測儀02,,,,濾芯完整性檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,硬度檢測儀01,,,,純化水制備檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,硬度檢測儀02,,,,純化水制備檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,余氯檢測儀01,,,,純化水制備檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,余氯檢測儀02,,,,純化水制備檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,濁度檢測儀01,,,,純化水制備檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,濁度檢測儀02,,,,純化水制備檢測,Y,Y,Y,Y,N,N,Y,B,N,Y,Y,N,Y,N,

,照度計,,,,潔凈區(qū)環(huán)境檢測,N,Y,Y,Y,N,N,Y,A,N,N,N,N,Y,N,調試

,風速儀,,,,潔凈區(qū)環(huán)境檢測,N,Y,Y,Y,N,N,Y,A,N,N,N,N,Y,N,調試

,轉速表,,,,工藝驗證,N,Y,Y,Y,N,N,N,A,N,N,N,N,Y,N,調試

,微差壓表,,,,潔凈區(qū)環(huán)境檢測,N,Y,Y,Y,N,N,N,A,N,N,N,N,Y,N,調試

,直流電阻箱,,,,溫度控制儀檢定