培養(yǎng)基模擬灌裝方案

1、文件編號(hào)MFVP有限公司有限公司頁(yè)碼1of136ml灌裝線灌裝線培養(yǎng)基模擬灌裝驗(yàn)證方案培養(yǎng)基模擬灌裝驗(yàn)證方案ml灌裝線培養(yǎng)基模擬灌裝驗(yàn)證方案灌裝線培養(yǎng)基模擬灌裝驗(yàn)證方案審批審批審批審批部門(mén)部門(mén)職務(wù)職務(wù)姓名姓名簽名簽名日期日期編寫(xiě)編寫(xiě)生產(chǎn)部操作員QA驗(yàn)證組組長(zhǎng)生產(chǎn)部車(chē)間主任生產(chǎn)部部長(zhǎng)設(shè)備管理部部長(zhǎng)質(zhì)量控制部負(fù)責(zé)人質(zhì)量保證部部長(zhǎng)審核審核生產(chǎn)管理負(fù)責(zé)人批準(zhǔn)批準(zhǔn)質(zhì)量管理負(fù)責(zé)人文件編號(hào)MFVP有限公司有限公司頁(yè)碼3of136ml灌裝線灌裝線培養(yǎng)基

2、模擬灌裝驗(yàn)證方案培養(yǎng)基模擬灌裝驗(yàn)證方案7.7.設(shè)備和器具：設(shè)備和器具：............................................................................................................................117.8.運(yùn)行頻次和周期運(yùn)行頻次和周期.........................................

3、...............................................................................127.9.運(yùn)行數(shù)量運(yùn)行數(shù)量...............................................................................................................................

4、....127.10.模擬物料和培養(yǎng)基模擬物料和培養(yǎng)基................................................................................................................127.11.密閉和開(kāi)放系統(tǒng)密閉和開(kāi)放系統(tǒng)............................................................

5、.......................................................137.12.風(fēng)險(xiǎn)評(píng)估風(fēng)險(xiǎn)評(píng)估..............................................................................................................................147.13.工藝風(fēng)險(xiǎn)分析工藝風(fēng)險(xiǎn)分析.....

6、..................................................................................................................167.14.模擬項(xiàng)目模擬項(xiàng)目...........................................................................................

7、...................................187.14.17.14.1模擬灌裝過(guò)程模擬灌裝過(guò)程....................................................................................................................187.14.27.14.2灌裝機(jī)各分裝器具經(jīng)滅菌后的無(wú)菌組裝灌裝機(jī)各分裝器具經(jīng)滅菌后

8、的無(wú)菌組裝..............................................................................187.14.37.14.3模擬最多進(jìn)入灌裝間的人數(shù)模擬最多進(jìn)入灌裝間的人數(shù)................................................................................................187

9、.14.47.14.4人員干預(yù)人員干預(yù).............................................................................................................................187.14.57.14.5模擬人員活動(dòng)模擬人員活動(dòng)..................................................

10、....................................................................197.14.67.14.6模擬最差條件模擬最差條件......................................................................................................................197.15.灌

11、裝體積灌裝體積..............................................................................................................217.16.模擬培養(yǎng)基灌裝樣品的培養(yǎng)和檢查模擬培養(yǎng)基灌裝樣品的培養(yǎng)和檢查..................................................................

12、..........217.17.人員人員.....................................................................................................................217.18.工藝模擬工藝模擬...................................................................

13、...........................................227.19.取樣計(jì)劃取樣計(jì)劃..............................................................................................................237.20.培養(yǎng)基灌裝產(chǎn)品的處理培養(yǎng)基灌裝產(chǎn)品的處理.........................

14、..................................................................237.21.培養(yǎng)基模擬灌裝清潔確認(rèn)培養(yǎng)基模擬灌裝清潔確認(rèn).....................................................................................................237.21.17.21.1設(shè)備的清潔結(jié)構(gòu)、取樣

15、位置及測(cè)試項(xiàng)目描述設(shè)備的清潔結(jié)構(gòu)、取樣位置及測(cè)試項(xiàng)目描述.......................................................................237.21.27.21.2樣品編號(hào)原則樣品編號(hào)原則...............................................................................................

16、.......................258.確認(rèn)確認(rèn)測(cè)試項(xiàng)目測(cè)試項(xiàng)目………………………………………………………………………………...259.偏差處理偏差處理………………………………………………………………………………………2610.變更控制變更控制………………………………………………………………………………………2611.附件清單附件清單………………………………………………………………………………………2612.支持性附錄清