ISO 19617:2018

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Traditional Chinese medicine - General requirements for the manufacturing process of natural products

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ISO 19617:2018

Traditional Chinese medicine - General requirements for the manufacturing process of natural products

PUBLISH DATE 2018
ISO 19617:2018

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
  • 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
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