生物制品gmp檢查指南(已修改)
2025-04-16 23:37 本頁(yè)面
【正文】 生物制品GMP檢查指南GMP INSPECTION GUIDELINE FOR BIOPRODUCT由國(guó)家食品藥品監(jiān)督管理局頒發(fā)ISSUED BY SFDA OF CHINA1. 機(jī)構(gòu)與人員 COMPANY ORGANIZATION AND PERSONNEL224。 0402：生物制品生產(chǎn)企業(yè)生產(chǎn)和質(zhì)量管理負(fù)責(zé)人是否具有相應(yīng)的專業(yè)知識(shí)（細(xì)菌學(xué)、病毒學(xué)、生物學(xué)、分子生物學(xué)、生物化學(xué)、免疫學(xué)、醫(yī)學(xué)、藥學(xué)等），并具有豐富的實(shí)踐經(jīng)驗(yàn)以確保在其生產(chǎn)、質(zhì)量管理中履行其職責(zé)。Whether the personnel who are in charge of the bioproducts production and quality management that have the corresponding knowledge background on Bacteriology, Virology, Biology, Molecular Biology, Biochemistry, Immunology, Medicine, Pharmaceutics etc. and to possess abundant experience to insure fulfilling the responsibilities in the production and quality management.224。 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(jìn)行專業(yè)（衛(wèi)生學(xué)、微生物學(xué)等）和安全防護(hù)培訓(xùn)。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。 ＊2201：生產(chǎn)用菌毒種與非生產(chǎn)用菌毒種、生產(chǎn)用細(xì)胞與非生產(chǎn)用細(xì)胞、強(qiáng)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)防制品等加工或灌裝是否同時(shí)在同一生產(chǎn)廠房?jī)?nèi)進(jìn)行。Whether the process or filling procedure 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, preventive product etc. are proceeding in the same facility at the same time. 224。 ＊2202：生產(chǎn)用菌毒種與非生產(chǎn)用菌毒種、生產(chǎn)用細(xì)胞與非生產(chǎn)用細(xì)胞、強(qiáng)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(yán)格分開(kāi)。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。 ＊2203：不同種類的活疫苗的處理、灌裝是否彼此分開(kāi)。Whether the process and filling for various living vaccines are separated from each others.224。 ＊2204：強(qiáng)毒微生物操作區(qū)是否與相鄰區(qū)域保持相對(duì)負(fù)壓，是否有獨(dú)立的空氣凈化系統(tǒng)，排出的空氣是否循環(huán)使用。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。 ＊2205：芽孢菌制品操作區(qū)是否與相鄰區(qū)域保持相對(duì)負(fù)壓，是否有獨(dú)立的空氣凈化系統(tǒng)，排出的空氣是否循環(huán)使用，芽孢菌制品的操作直至滅活過(guò)程完成之前是否使用專用設(shè)備。Whether the pressure in the operation area for the spore bacteria preparation to be kept relatively negative paring to the abut areas. And is there independent air system and is the air recirculated? Is there specified equipment to be applied although the duration of spore bacteria product preparation until the inactivation procedure? 224。 ＊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。Whether the air system for various bioproducts related to high risk pathogenic factors which are in pliance with t
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