ISO 19617:2018

Overview

ISO 19617:2018 - Traditional Chinese medicine - General requirements for the manufacturing process of natural products - defines general requirements to ensure the quality of finished products used in Traditional Chinese Medicine (TCM). It covers manufacturing of natural-origin materials including medicinal plants, animals and minerals, as well as crude drugs and crude drug preparations. The standard complements, and does not conflict with, general pharmaceutical Good Manufacturing Practices (GMPs).

Key topics and technical requirements

ISO 19617:2018 focuses on process-level controls and quality assurance specific to natural TCM materials. Major technical topics include:

• Premises and sanitation

  • Requirements for storage areas and production areas to protect natural materials.
  • Sanitation practices appropriate for handling plant, animal and mineral inputs.

• Documentation

  • Documentation for crude drugs, crude drug preparations and finished TCM products.
  • Processing instructions and batch records to ensure traceability and reproducibility.

• Personnel and training

  • Roles and responsibilities including a crude drug control manager.
  • Competency, training programs and personnel hygiene tailored to perceptive identification and handling of natural materials.

• Manufacturing control

  • Change control and deviation control procedures to manage process modifications and nonconformances.
  • Self-inspection and internal audit mechanisms to verify GMP alignment.

• Quality control

  • Controls for identity, purity and quality of starting materials and finished products.
  • Use of marker substances, constituent definitions, and analytical/organoleptic identification methods where appropriate.

• Scope of application

  • Applies to multi‑herbal formulations common in East Asian TCM and materials of non-plant origin (animals, minerals).

Practical applications - who uses ISO 19617:2018

This ISO standard is practical for:

• Manufacturers of TCM natural products and contract manufacturers.
• Quality assurance and regulatory compliance teams implementing GMP for herbal and natural medicines.
• Procurement and raw-material specialists who source medicinal plants, animals or minerals.
• Inspectors, auditors and national regulatory bodies assessing TCM manufacturing practices.
• R&D and production managers designing processes for multi-herb formulations.

Using ISO 19617:2018 helps organizations improve product safety and consistency, demonstrate due diligence to regulators and trading partners, and align TCM manufacturing with internationally recognized quality controls.

Related standards and references

• General pharmaceutical GMPs (WHO, PIC/S, EU) - ISO 19617:2018 is intended to complement these.
• ISO/TC 249 guidance on Traditional Chinese Medicine - technical context for the standard.

Keywords: ISO 19617:2018, Traditional Chinese medicine, TCM manufacturing, GMP, natural products, crude drugs, quality control, manufacturing process, medicinal plants.