ISO/DIS 19617

This Draft International Standard is in the enquiry phase with ISO members.

Will replace ISO 19617:2018

Abstract

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.

General information

Status
: Under development

Stage
: Full report circulated: DIS approved for registration as FDIS [40.99]
Edition
: 2
Technical Committee :
ISO/TC 249

ICS :
11.120.10
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