生物制品GMP检查指南双语版.docxVIP

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 CHINA机构与人员COMPANY ORGANIZATION AND PERSONNEL0402：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, Medicine, 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.厂房与设施PREMISE AND FACILITY＊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 aboutthe 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 the storage aboutthe 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 relatively negative comparing to the abut areas. And is there