ISO 23419:2021 PDF

Name: ISO 23419:2021 — Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules
SKU: ISO 23419:2021
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Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules

Название (английский):

ISO 23419:2021

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 7 декабря 2021 г.
Издание:: ISO IS 23419 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

ISO 23419:2021 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

ISO 19617:2018

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

ISO 19609-1:2021

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ISO 23723:2021

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ISO 2137:1972

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ISO 22283:2020

Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD

ISO 22467:2021

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