生物药产业国际标准化研究OACHSSCD

This article briefly introduces the main international standards organizations in the biopharmaceutical industry,studies the current and revised major international standards for biopharmaceuticals,analyzes the development trends of international standards for biopharmaceuticals in the International Organization for Standardization(ISO),the World Health Organization(WHO),and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH),and proposes suggestions for continuously adopting standards,strengthening full process management,building a multi-level standardization talent system,and deeply participating in the governance of international standards organizations.These suggestions provide standard technical support for China's biopharmaceutical industry to align with international standards and provide useful references for deep participation in international standardization work for biopharmaceuticals.