生物制品gmp檢查指南(編輯修改稿)
2025-05-01 23:37 本頁面
【文章內(nèi)容簡介】 binant DNA products), toxoid and cell extract which can be filling and lyophilized in the same equipment alternately with others sterile products after inactivation or disinfecting process. But after the distribution of one product, the equipment must be effectively cleaned and disinfected right away and verify the effectiveness of cleaning and disinfecting periodically. 224。 ＊2218：操作有致病作用的微生物是否在專門的區(qū)域內(nèi)進行，是否保持相對負壓。Whether the process of pathogenic microorganism is applied in the specified area and whether it kept relatively negative pressure in this area.224。 ＊2219：有菌（毒）操作區(qū)與無菌（毒）操作區(qū)是否有各自獨立的空氣凈化系統(tǒng)，來自病原體操作區(qū)的空氣是否循環(huán)使用。Are there independent air decontamination systems between toxic and nontoxic working areas and is the air in the pathogen process area recirculated?224。 ＊2220：來自危險度為二類以上病原體的空氣是否通過除菌過濾器排放，濾器的性能是否定期檢查。使用二類以上的病原體強污染性材料進行制品生產(chǎn)時，對其排出污物是否有有效的消毒設(shè)施。Whether the air from the rooms of pathogen hazard class 2 or above which is filtered before to let out. Whether the specification of filter is verified periodically. Whether the waste from the drainage of the area where manufacturing the pathogen intensively polluted material above hazard class 2. And whether the waste from it is effectively disinfected.224。 2221：用于加工處理活生物體的生物制品生產(chǎn)操作區(qū)和設(shè)備是否便于清潔和去除污染，能耐受熏蒸消毒。Whether the facility and equipment to be applied in processing the living organism which are convenient to be cleaned and disinfected, and be tolerant to the suffocating sterilization. 224。 2802：生物檢定、微生物限度檢查是否分室進行。Whether the inspection for biological material and microorganism limitation those are proceeded in different rooms.224。 ＊3002：用于生物制品生產(chǎn)的動物室、質(zhì)量檢定動物室是否與生物制品生產(chǎn)區(qū)各自分開。Whether the animal rooms for bioproduct manufacture and quality control those are separated with production areas. 224。 ＊3003：生物制品所使用動物的飼養(yǎng)管理要求，是否符合實驗動物管理規(guī)定。Whether the requirement of management for animal which to be applied in bioproduct manufacturing to be in pliance with the relevant provision. 3. 設(shè)備 EQUIPMENT224。 3103：生物制品生產(chǎn)使用的管道系統(tǒng)、閥門和通氣過濾器是否便于清潔和滅菌，封閉性容器（如發(fā)酵罐）是否用蒸汽滅菌。Whether the pipeline system, valves and ventilator filters to be used in bioproduct manufacture that are convenient to be cleaned and sterilized. And whether the airlocked containers (such as: bioreactor) to be sterilized with autoclave (. steam sterilization).224。 ＊3402：注射用水的制備、儲存和分配是否能防止微生物的滋生和污染，儲罐的通氣口是否安裝不脫落纖維的疏水性除菌濾器，儲存是否采用80℃以上保溫、65℃以上保溫循環(huán)或4℃以下存放。Whether the procedures such as preparation, storage and distribution of injection water that can prevent the microorganisms from growing and pollution. Is the vent of storage tank installed with nonfiber shedding hydrophobic sterile filter? In the storage of injection water, is the temperature kept ab
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