【正文】 ? Have operators been trained in filter use sterilization, integrity testing ?是否對過濾器的使用者進(jìn)行了過濾器滅菌，完整性監(jiān)測的培訓(xùn)？? Is this training documented ?這些培訓(xùn)有相關(guān)記錄嗎？? Is this training adequate for the functions required ?這些培訓(xùn)足夠嗎？Examples of observations觀察到的例子：? Operator training is not documented對操作者的培訓(xùn)沒有記錄? Operators not formally trained in integrity test操作者不熟悉完整性的檢測Control of filter devices 過濾設(shè)備的管理? Is filter inspected on arrival ?過濾器到貨后是否經(jīng)過檢查？? Is filter stored to prevent mix ups / contamination ?過濾器的儲存是否有防止發(fā)生混淆的措施？? Is filter Certificate of Quality filed 。 where ?過濾器是否有質(zhì)量證書？放在哪里？? Are old / obsolete filters in use ?是否一些淘汰的廢棄的過濾器仍在使用？Examples of observations例子? Filters not inspected and therefore an incorrect filter is issued to manufacturing應(yīng)為沒有對過濾器進(jìn)行檢查造成過濾器被錯誤的發(fā)放到生產(chǎn)線 Very old / obsolete filters issued to manufacturing非常老舊的過濾器被發(fā)放到了生產(chǎn)線。Documentation setup and management文件建立與管理? Do procedures conform to GMP ?制定的規(guī)程是否符合GMP的要求？? Are procedures up to date and correct ? 指定的規(guī)程是最新的和正確的嗎？? Are procedures followed ? 這些規(guī)程是否被遵照執(zhí)行？? Are procedures / reports readily accessible ?這些規(guī)程或報告是否容易被拿到？Examples of observations例子? Different versions of the same procedure 發(fā)現(xiàn)了同一文件的不同版本? Procedures never updated with new filters / integrity test criteria? 規(guī)程中的過濾器型號和 完整性測試標(biāo)準(zhǔn) 沒有被更新Process control and Environmental monitoring工藝控制和環(huán)境監(jiān)測? Are critical parameters monitored (differential pressures / temperatures / times) and controlled ? 關(guān)鍵的參數(shù)是否被監(jiān)測？（壓差 /溫度 /時間 )?? Is critical equipment calibrated ?關(guān)鍵的設(shè)備是否被計量和校驗？? Is integrity testing performed correctly ?完整性測試是否被正確的執(zhí)行？? Are critical areas monitored adequately ?關(guān)鍵的地點是否有足夠的檢測？Process control and Environmental monitoring工藝控制和環(huán)境監(jiān)測（續(xù)）Examples of observations例子? Filter specifications being exceeded過濾器的使用標(biāo)準(zhǔn)被超過? Incorrect / inadequate integrity test methods 完整性測試方法不正確和不充分? Lack of traceability for results 缺乏對結(jié)果的跟蹤Sterilization of filters 過濾器的滅菌? Are filters sterilized according to manufacturers remendations ? 是否按照過濾器生產(chǎn)廠家的推薦進(jìn)行滅菌？? Is the sterilization correctly validated ? 滅菌過程是否經(jīng)過驗證？? Is the sterilization monitored and controlled ? 過濾器滅菌是否受到監(jiān)測與控制？Sterilization of filters 過濾器的滅菌（續(xù)）Examples of observations例子? Filter damage due to reverse pressure過濾器受反壓而損壞? Inadequate validation不足夠的驗證? Lack of validation data缺乏驗證數(shù)據(jù)過濾器的滅菌設(shè)計Water system 水純化系統(tǒng)及其中過濾系統(tǒng)管理? Water filters。 how is change out frequency determined ?水系統(tǒng)所用濾器： 更換頻次是多少？如何決定的？? What is the effect on retention and endotoxin levels due to filter usage ?由于過濾器的使用，細(xì)菌截留和內(nèi)毒素水平會受到那些影響？? Vent filters。 how is change out determined ?呼吸器：如何決定更換？Examples of observations例子? Lack of change out data沒有更換記錄? Lack of control on water filtration對水的過濾器沒有控制? Lack of integrity testing of vent filters缺乏呼吸器完整性測試結(jié)果 取樣方法Validation of Filters與生產(chǎn)相關(guān)的驗證? Has filter sterilization been validated ?過濾器的滅菌是否經(jīng)過驗證？? Has bacterial retention been validated ?是否做過細(xì)菌截留驗證？? Has patibility / extractables / adsorption been dealt with during validation ? 在驗證過程中是否進(jìn)行了兼容性和析出物實驗? Have product integrity ratios been established ? 是否建立了產(chǎn)品起泡點標(biāo)準(zhǔn)Examples of observations例子? No sterilization data沒有滅菌的數(shù)據(jù)? No product specific retention data沒有產(chǎn)品細(xì)菌截留數(shù)據(jù)? No product integrity ratio data沒有產(chǎn)品起泡點率的數(shù)據(jù)? No patibility data沒有兼容性實驗數(shù)據(jù)過濾器驗證項目Biological生物性能– Microbial Retention微生物截留? Customized to客戶定制Flow Rate流速Throughput產(chǎn)量Process temperature操作溫度Pressure壓力System Size系統(tǒng)尺寸大小Physical物理性能– Integrity完整性? Product/water BP ratio產(chǎn)品／水起泡點? Diffusion ratio擴散流– Binding吸附Chemical化學(xué)性能216。 Compatibility216。 Extractables兼容性＼析出物討論