培養(yǎng)基模擬灌裝方案

1、文件編號MFVP有限公司有限公司頁碼1of136ml灌裝線灌裝線培養(yǎng)基模擬灌裝驗證方案培養(yǎng)基模擬灌裝驗證方案ml灌裝線培養(yǎng)基模擬灌裝驗證方案灌裝線培養(yǎng)基模擬灌裝驗證方案審批審批審批審批部門部門職務職務姓名姓名簽名簽名日期日期編寫編寫生產(chǎn)部操作員QA驗證組組長生產(chǎn)部車間主任生產(chǎn)部部長設備管理部部長質(zhì)量控制部負責人質(zhì)量保證部部長審核審核生產(chǎn)管理負責人批準批準質(zhì)量管理負責人文件編號MFVP有限公司有限公司頁碼3of136ml灌裝線灌裝線培養(yǎng)基

2、模擬灌裝驗證方案培養(yǎng)基模擬灌裝驗證方案7.7.設備和器具：設備和器具：............................................................................................................................117.8.運行頻次和周期運行頻次和周期.........................................

3、...............................................................................127.9.運行數(shù)量運行數(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.密閉和開放系統(tǒng)密閉和開放系統(tǒng)............................................................

5、.......................................................137.12.風險評估風險評估..............................................................................................................................147.13.工藝風險分析工藝風險分析.....

6、..................................................................................................................167.14.模擬項目模擬項目...........................................................................................

7、...................................187.14.17.14.1模擬灌裝過程模擬灌裝過程....................................................................................................................187.14.27.14.2灌裝機各分裝器具經(jīng)滅菌后的無菌組裝灌裝機各分裝器具經(jīng)滅菌后

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

9、.14.47.14.4人員干預人員干預.............................................................................................................................187.14.57.14.5模擬人員活動模擬人員活動..................................................

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.取樣計劃取樣計劃..............................................................................................................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培養(yǎng)基模擬灌裝清潔確認.....................................................................................................237.21.17.21.1設備的清潔結構、取樣

15、位置及測試項目描述設備的清潔結構、取樣位置及測試項目描述.......................................................................237.21.27.21.2樣品編號原則樣品編號原則...............................................................................................

16、.......................258.確認確認測試項目測試項目………………………………………………………………………………...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