ISO 23419:2021 PDF

Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules

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Title (English):

ISO 23419:2021

Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 17
Publication date:: December 7, 2021
Edition:: ISO IS 23419 edition 1 version 1
ICS:: 11.120.10

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Description (English):

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

Technical details

Technical committee: ISO/TC 249 - Traditional Chinese medicine
SKU: ISO 23419:2021

Abstract

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.

Related standards

Standards mentioned in the description

Abstract

Overview

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.

ISO 23419:2021 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Related standards

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