标准编号:ISO 19617:2018
中文名称:中药 天然产品生产过程的一般要求
英文名称:Traditional Chinese medicine — General requirements for the manufacturing process of natural products
发布日期:2018-04
标准范围
This document specifies the general requirements for manufacturing processes to ensure the quality of finished products used in traditional Chinese medicine (TCM). This document covers premises, documentation, personnel, training, manufacturing control and quality control. This document applies to the manufacturing of natural products used in and as TCM.
This document does not conflict with general pharmaceutical good manufacturing practices (GMPs).
This document applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.