生物制品gmp檢查指南-wenkub
2023-04-19 23:37:54 本頁面
【正文】 專用于生產(chǎn)孢子形成體，當加工處理一種制品時是否集中生產(chǎn)，某一設(shè)施或一套設(shè)施中分期輪換生產(chǎn)芽孢菌制品時，在規(guī)定時間內(nèi)是否只生產(chǎn)一種制品。 ＊2208：卡介苗生產(chǎn)廠房和結(jié)核菌素生產(chǎn)廠房是否與其它制品生產(chǎn)廠房嚴格分開，卡介苗生產(chǎn)設(shè)備要專用。 ＊2206：各類生物制品生產(chǎn)中涉及高危致病因子的操作，其空氣凈化系統(tǒng)等設(shè)施是否符合特殊要求。 ＊2204：強毒微生物操作區(qū)是否與相鄰區(qū)域保持相對負壓，是否有獨立的空氣凈化系統(tǒng)，排出的空氣是否循環(huán)使用。 ＊2202：生產(chǎn)用菌毒種與非生產(chǎn)用菌毒種、生產(chǎn)用細胞與非生產(chǎn)用細胞、強毒與弱毒、死毒與活毒、脫毒前與脫毒后的制品和活疫苗與滅活疫苗、人血液制品、預(yù)防制品等貯存是否嚴格分開。 0702：從事生物制品制造的全體人員（包括清潔人員、維修人員）是否根據(jù)其生產(chǎn)的制品和所從事的生產(chǎn)操作進行專業(yè)（衛(wèi)生學(xué)、微生物學(xué)等）和安全防護培訓(xùn)。生物制品GMP檢查指南GMP INSPECTION GUIDELINE FOR BIOPRODUCT由國家食品藥品監(jiān)督管理局頒發(fā)ISSUED BY SFDA OF CHINA1. 機構(gòu)與人員 COMPANY ORGANIZATION AND PERSONNEL224。Whether all the personnel (including the cleaning stuff and maintenance stuff) that related with the bioproducts production who have received the professional training on production and corresponding knowledge (Hygiene, Microbiology etc.) and security training.2. 廠房與設(shè)施 PREMISE AND FACILITY224。Whether the storage about the production or nonproduction cell bank or seed bank, strong or weak strain, inactive or active strain, before or after detoxicant, dead or living strain, human blood product, defendant product etc. are strictly separated.224。Whether the pressure in the operation area for the strong strain to be kept relatively negative paring to the abut areas. And is there independent air system and is the air recirculated?224。Whether the air system for various bioproducts related to high risk pathogenic factors which are in pliance with the special requirement. 224。Whether the premise for the BCG vaccine or tuberculin production which is strictly separated with others premise. And the equipment for BCG vaccine production must be specified. 224。The equipment must be specified in the production of sporeformer. Is the production centralized when processing one preparation? When manufacturing different varieties of spore products with one set of equipment in turn, is that only one product to be prepared in the established period. 224。Whether the production and inspection of PCR reagents to be proceeded in the isolated area to prevent the crosscontamination caused by aerosol in the amplification procedure. 224。Whether only authorized personnel are permitted to enter the area where storing the seed lot and cell bank and whether all these materials are stored in the specified warehouse pursuant to the specified condition. 224。The bioproduct manufactures which manipulated with the airlocked bioreactor that can be preceded in the same area at same time (. monoclonal antibody amp。All kinds of inactive vaccines (including rebinant 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
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