BS 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。本文件与通用制药良好生产规范（GMP）不冲突。本文件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。交叉引用:ISO/IEC/TR 10000-1ISO 6900 ISO 128-44ISO 80000（所有部分）ISO 128-30ISO 10241-1ISO 128-40IEC 60027（所有部分）ISO 128-34ISO 19609（所有部分）购买本文件时可获得的所有现行修订均包含在购买本文件中。

BS 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.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.Cross References:ISO/IEC/TR 10000-1ISO 690ISO 128-44ISO 80000 (all parts)ISO 128-30ISO 10241-1ISO 128-40IEC 60027 (all parts)ISO 128-34ISO 19609 (all parts)All current amendments available at time of purchase are included with the purchase of this document.