摘要
《中国生物制品规程》是生物制品质量控制的国家标准 ,是国家对生物制品生产及检定实施质量监督管理的主要依据。本文通过阐述《中国生物制品规程》制定的发展和现状 ,反映了我国生物制品质量不断提高、种类不断增加的进程 ,以及《中国生物制品规程》对生物制品标准化所起到的推动作用。
Chinese Requirements for Biological Products(CRBP) is national standards for quality control of biological products,based upon which the state exercises the supervision and administration of production and quality control of biologics. This article describes briefly the development and current status of CRBP, from which the progress made in the quality improvements and diversity of biologics is showed. It stresses that the development of CRBP plays an important role in the standardization of biological products in China.
出处
《中国药事》
CAS
2001年第2期125-127,共3页
Chinese Pharmaceutical Affairs
