生物制品GMP检查指南(双语版)

1、编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页 共1页生物制品GMP检查指南GMP INSPECTION GUIDELINE FOR BIO-PRODUCT由国家食品药品监督管理局颁发ISSUED BY SFDA OF CHINA1. 机构与人员 COMPANY ORGANIZATION AND PERSONNEL 0402：生物制品生产企业生产和质量管理负责人是否具有相应的专业知识（细菌学、病毒学、生物学、分子生物学、生物化学、免疫学、医学、药学等），并具有丰富的实践经验以确保在其生产、质量管理中履行其职责。Whether the personnel who are in charge of the bio-products production and quality management that have the corresponding knowledge background on Bacteriology, Virology, Biology, Molecular Biology, Biochemistry, Immunology, Medic

2、ine, Pharmaceutics etc. and to possess abundant experience to insure fulfilling the responsibilities in the production and quality management. 0702：从事生物制品制造的全体人员（包括清洁人员、维修人员）是否根据其生产的制品和所从事的生产操作进行专业（卫生学、微生物学等）和安全防护培训。Whether all the personnel (including the cleaning stuff and maintenance stuff) that related with the bio-products production who have received the professional training on production and corresponding knowledge (Hygiene, Microbiology etc.) and security training.2. 厂房与设施 PREMISE AND F

3、ACILITY 2201：生产用菌毒种与非生产用菌毒种、生产用细胞与非生产用细胞、强毒与弱毒、死毒与活毒、脱毒前与脱毒后的制品和活疫苗与灭活疫苗、人血液制品、预防制品等加工或灌装是否同时在同一生产厂房内进行。Whether the process or filling procedure about the production or non-production 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. 2202：生产用菌毒种与非生产用菌毒种、生产用细胞与非生产用细胞、强毒与弱毒、死毒与活毒、脱毒前与脱毒后的制品和活疫苗与灭活疫苗、人血液制品、预防制品等贮存是否严格分开。Whether

4、 the storage about the production or non-production 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. 2203：不同种类的活疫苗的处理、灌装是否彼此分开。Whether the process and filling for various living vaccines are separated from each others. 2204：强毒微生物操作区是否与相邻区域保持相对负压，是否有独立的空气净化系统，排出的空气是否循环使用。Whether the pressure in the operation area for the strong strain to be kept relativel

5、y negative comparing to the abut areas. And is there independent air system and is the air re-circulated? 2205：芽孢菌制品操作区是否与相邻区域保持相对负压，是否有独立的空气净化系统，排出的空气是否循环使用，芽孢菌制品的操作直至灭活过程完成之前是否使用专用设备。Whether the pressure in the operation area for the spore bacteria preparation to be kept relatively negative comparing to the abut areas. And is there independent air system and is the air re-circulated? Is there specified equipment to be applied although the duration of spore bacteria product preparation until th

6、e inactivation procedure? 2206：各类生物制品生产中涉及高危致病因子的操作，其空气净化系统等设施是否符合特殊要求。Whether the air system for various bio-products related to high risk pathogenic factors which are in compliance with the special requirement. 2207：生物制品生产过程中使用某些特定活生物体阶段的设备是否专用，是否在隔离或封闭系统内进行。Whether the equipment to be used in special phase of production for some living organisms in the manufacture of bio-product which is separated and been applied in the isolated environment. 2208：卡介苗生产厂房和结核菌素生产厂房是否与其它制品生产厂房严格分开，卡介苗生产设备要专用。Wh

7、ether 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. 2209：炭疽杆菌、肉毒梭状芽孢杆菌和破伤风梭状芽孢杆菌制品在相应专用设施内生产。Whether the b.authraci, Clostridium Botulinum and Clostridium tetanus preparation those are manufactured with specified equipment. 2210：设备专用于生产孢子形成体，当加工处理一种制品时是否集中生产，某一设施或一套设施中分期轮换生产芽孢菌制品时，在规定时间内是否只生产一种制品。The equipment must be specified in the production of sporeformer. Is the produ

8、ction 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. 2211：生物制品生产的厂房与设施是否对原材料、中间体和成品存在潜在污染。Whether the premise and facility which to be applied to manufacture the bio-products that will pollute the raw material, intermediate product and final product potentially. 2212：聚合酶链反应试剂（PCR）的生产和检定是否在各自独立的建筑物中进行，防止扩增时形成的气溶胶造成交叉污染。Whether the production

9、and inspection of PCR reagents to be proceeded in the isolated area to prevent the cross-contamination caused by aerosol in the amplification procedure. 2213：生产人免疫缺陷病毒（HIV）等检测试剂，在使用阳性样品时，是否有符合相应规定的防护措施和设施。When manufacturing the HIV relevant test reagents, is there any equipment or facility in compliance with the established provision during the process of manipulating the positive sample. 2214：生产用种子批和细胞库，是否在规定储存条件下专库存放，是否只允许指定的人员进入。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. 2215：以人血、人血浆或动物脏器、组织为原料生产的制品是否使用专用设备，是否与其他生物制品的生产严格分开。Is there specified equipment to be applied to the production which based on the raw material of human blood, human plasma or animal tissue? Is this kind of product

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