Draft International Standard
ISO/DIS 19617
Traditional Chinese medicine — General requirements for the manufacturing process of natural products
Reference number
ISO/DIS 19617
ISO/DIS 19617
Edición 2
© ISO 2024
Draft
International Standardu
ISO/DIS 19617
88667
No disponible en español
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
Reemplazará ISO 19617:2018
Resumen
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.
Informaciones generales
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Estado: En desarrolloEtapa: Informe completo distribuido: DIS aprobado para su registro como FDIS [40.99]
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Edición: 2
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Comité Técnico :ISO/TC 249ICS :11.120.10
- RSS actualizaciones
Ciclo de vida
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Anteriormente
PublicadoISO 19617:2018
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Ahora
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