ISO 19609-1:2021

Overview

ISO 19609-1:2021 - "Traditional Chinese medicine - Quality and safety of raw materials and finished products made with raw materials - Part 1: General requirements" - sets out the general requirements for a quality control framework applied to raw materials and finished products used in Traditional Chinese Medicine (TCM). The standard covers the classification of TCM materials (raw materials, decoction pieces, modernized finished products and non‑traditional phytotherapy products) and the comparison between starting materials and final products where relevant.

Keywords: ISO 19609-1, Traditional Chinese medicine, TCM quality, raw materials, finished products, quality control.

Key topics and technical requirements

ISO 19609-1 defines high‑level requirements and testing topics that a TCM quality system should address, including:

• Product classification: decoction pieces, medicinal decoctions, concentrates, powders, capsules, tablets, granules, and non‑traditionally produced phytotherapy products.
• Quality testing framework: general testing procedures and staged testing approaches for raw materials and finished products.
• Physical parameters and sampling:
  • Bulk and test sampling methods to obtain representative samples.
  • Estimation of water content of herbals and products (references include ISO 760 and Karl Fischer methods).
  • Particle size estimation for powders and small dosage forms.
• Dosage form performance:
  • Uniformity of dosage units.
  • Disintegration and dissolution testing for solid oral forms (tablets, capsules).
  • pH measurement for liquids/solutions (reference to ISO 10523).
• Residual solvents: assessment and testing methods for organic volatile solvents used in extraction or manufacturing.
• Stability: general requirements for evaluating the stability of TCM products during shelf life and storage.
• Terminology and definitions: consistent definitions for active substance, decoction piece, finished product, raw material, residual solvent, etc.

Practical applications and users

ISO 19609-1 is aimed at organizations and professionals involved in the manufacture, testing, regulation and supply of TCM products:

• Manufacturers and contract manufacturers - to design quality control systems, sampling plans and in‑process controls for raw materials and finished products.
• Quality control and analytical laboratories - to align testing procedures for water content, particle size, dissolution, disintegration, pH and residual solvents.
• Regulators and compliance teams - to assess conformity, safety and comparability of TCM products and submissions.
• Raw material suppliers and contract growers - to understand requirements for material acceptance, sampling and documentation.
• Formulators and R&D - to compare starting materials with finished products and to evaluate stability and performance of modernized TCM dosage forms.

Keywords: TCM testing methods, sampling TCM, residual solvent testing, TCM stability, dosage uniformity.

Related standards

Normative references and closely related documents include:

• ISO 760 - Determination of water - Karl Fischer method
• ISO 10523 - Water quality - Determination of pH
• ISO 12937 - Determination of water - Coulometric Karl Fischer titration
• ISO 19609-2 - Identity testing of constituents of herbal origin
• ISO 22217 - Storage requirements for Chinese materia medica and decoction pieces

ISO 19609-1 provides the general, harmonized foundation for implementing robust TCM quality and safety programs across manufacturing, testing and regulatory activities.