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世界卫生组织生物标准化专家委员会第42次会议1991年10月22至29日在日内瓦WHO总部召开.参加这次会议的有英、美、苏、加拿大、尼日利亚、澳大利亚、巴基斯坦、丹麦、伊朗和中国共14名,欧洲药典及国际制药协会亦派员参加.会议共讨论了46个议题,重点讨论了生物制品GMP补充规定、国家管理部门对生物制品质量保证的指导原则、人用单克隆抗体的规程及国际标准品的建立.现将主要内容介绍如下:
The 42nd meeting of the WHO Expert Committee on Biological Standardization was held at the WHO headquarters in Geneva from October 22 to 29, 1991. The meeting was attended by representatives from Britain, the United States, the United States, the Soviet Union, Canada, Nigeria, Australia, Pakistan, Denmark, Iran and China A total of 14, the European Pharmacopoeia and the International Pharmaceutical Association also sent representatives to attend the meeting discussed a total of 46 topics, focusing on the GMP supplement biological products, the national regulatory authorities on biological products quality assurance guidelines, human monoclonal antibodies Procedures and the establishment of international standards. Now the main contents are as follows: