ISO 19617:2018规定了制造工艺的一般要求，以确保中药成品的质量。本文件涵盖场地、文件、人员、培训、制造控制和质量控制。本文件适用于中药中使用的天然产品的制造。 ISO 19617:2018与通用制药良好生产规范（GMP）不冲突。 ISO 19617:2018适用于所有天然来源的材料:药用植物、药用动物、药用矿物、生药或生药制剂。

ISO 19617:2018 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. ISO 19617:2018 does not conflict with general pharmaceutical good manufacturing practices (GMPs). ISO 19617:2018 applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.