ISO 23419:2021

Overview

ISO 23419:2021 - Traditional Chinese medicine - General requirements for manufacturing procedures and quality assurance of granules - defines general requirements for the manufacture, quality control and safety assurance of granules and compactates made from traditional Chinese medicine (TCM) extracts or powders for oral use. The standard covers the full production chain from raw material handling through granulation/compaction to packaging and testing. It explicitly excludes granules or compactates made from chemically pure (chemically defined) compounds.

Key topics and technical requirements

ISO 23419:2021 addresses both manufacturing process controls and analytical/quality requirements. Major technical topics include:

• Manufacturing process stages:

  • Crushing / milling of decoction pieces
  • Extraction, liquid–solid separation, concentration and drying
  • Granulation methods: dry, semi‑dry and wet granulation
  • Compaction to produce compactates
  • Packaging and labelling for oral dosage units

• Process governance:

  • Controlled conditions for facilities and equipment to ensure consistency with traditional decoction quality
  • Identification and experimental verification of critical parameters prior to scale‑up
  • Laboratory and pilot verification followed by at least three production lots at commercial scale for validation
  • Conformance with ISO 19617 general manufacturing principles

• Quality assurance and analytical testing:

  • Identification and assay of constituents
  • Particle size and particle size distribution, dissolution/disintegration testing
  • Moisture content determination and uniformity of dosage units
  • Equivalency evaluation (comparability to decoction or reference)
  • Safety tests for pesticide residues, heavy metals, aflatoxins and microbiological contaminants

• Informative annexes:

  • Guidance on production/selection of crude drugs, particle size distribution, equivalency evaluation and determination of methanol‑soluble extractives.

Applications and who uses it

ISO 23419:2021 is intended for organizations involved in TCM granule production and quality oversight, including:

• Manufacturers and contract producers of TCM granules/compactates
• Quality assurance and regulatory affairs teams
• R&D and process development groups scaling laboratory methods to production
• Analytical laboratories performing identification, assay and safety testing
• National regulators and certification bodies assessing compliance with TCM product quality and safety

This standard supports reliable, reproducible manufacturing and helps ensure that granules deliver consistent quality, safety and performance comparable to traditional decoctions.

Related standards

Relevant ISO documents referenced in ISO 23419:2021 include:

• ISO 19617, ISO 19609‑1/2, ISO 23723, ISO 18664, ISO 21371, ISO 22283, ISO 22467 - covering broader manufacturing requirements, raw materials, heavy metals, labelling, aflatoxins and microbiological testing.