Draft
International Standard
ISO/DIS 19617
Traditional Chinese medicine — General requirements for the manufacturing process of natural products
Reference number
ISO/DIS 19617
Edition 2
Projet Norme internationale
Preview
ISO/DIS 19617
88667
Indisponible en français
Projet de Norme internationale au stade enquête auprès des membres de l’ISO.
Remplacera ISO 19617:2018

Résumé

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.

Informations générales

  •  : Projet
    : Rapport complet diffusé: DIS approuvé pour enregistrement comme FDIS [40.99]
  •  : 2
  • ISO/TC 249
    11.120.10 
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