金币
UID673924
帖子
主题
积分4252
注册时间2020-11-13
最后登录1970-1-1
听众
性别保密
|
发表于 2022-2-23 09:03:22
|
显示全部楼层
These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal)products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug(medicinal) products, biological and biotechnological products). 这些方面包括活性成分、药物(医疗)产品、生物和生物技术产品(包括原料、溶剂、辅料、药品(医疗)产品、生物和生物技术产品中原料、溶剂、辅料、包装和标签材料的使用)整个生命周期的开发、制造、分销以及检验和提交/审查过程。--ICH Q9 《风险管理》 |
|