摘要
由于生物制品生产的原材料、生产工艺和检定方法本身固有的生物易变性和复杂性 ,以及绝大部分生物制品用于健康的儿童 ,WHO提出了国家药品管理当局对生物制品管理的 6项基本职能 ,并详细规定了执行该 6项基本职能的技术指标。国家药品管理当局通过执行上述职能 ,即可最大限度地确保生物制品的质量。
Because of the biological variability and complexity of the raw materials, manufacture processes and test methods of biological products, and the target people of use of vaccines are usual very large numbers of healthy infants, WHO has identified 6 essential regulatory functions shall be undertaken by the national vaccine control authority. Through undertaken the 6 critical control functions by national regulatory authority, the quality, safety and efficacy of biological products can be assured.
出处
《中国药事》
CAS
2000年第3期159-162,共4页
Chinese Pharmaceutical Affairs
关键词
生物制品
国家管理
职能
biological products
national regulation
control functions
