Overview
ISO 24825:2026 sets out the general principles for establishing herbal reference substances used in Traditional Chinese Medicine (TCM). These substances are crucial for the quality control of herbal medicines in international trade, covering both raw materials and finished products. The standard provides uniform requirements for production, quality control, reporting, instructions and labelling, packaging, storage, and transportation of herbal reference substances, building confidence among manufacturers, regulators, and consumers in global herbal medicine markets.
Key Topics
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Definitions and Types of Herbal Reference Substances
- Herbal reference substance: Derived from medicinal plants and used as a standard for identification and quality testing.
- Three main types: herbal reference material, herbal reference extract, and herbal chemical reference substance.
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Establishment Principles
- Requirements for sourcing authentic raw materials, with clear botanical identification.
- Preparation protocols tailored to specific herb characteristics.
- Homogenization to ensure consistent composition and structure across batches.
- Testing procedures to determine essential criteria such as purity, moisture, ash, and solvent residues.
- Identification methods validated for specificity and reproducibility, including macroscopic, microscopic, physicochemical, and biological approaches.
- Stability testing to confirm long-term reliability and appropriate storage instructions.
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Quality Control and Documentation
- Implementation of quality management and traceability in line with best practices such as GMP and GLP.
- Detailed reporting via certificates of analysis, specifying batch details, producer information, physical characteristics, and analytical values.
- Labelling requirements include batch number, storage conditions, instructions, and hazard symbols where necessary.
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Packaging, Storage, and Transportation
- Use of packaging that preserves integrity, prevents contamination, and ensures stability according to the physical and chemical characteristics of the reference substance.
- Clear guidelines on environmental controls during storage and transportation to maintain substance quality.
Applications
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Quality Control in International Trade
- Herbal reference substances are essential for quality inspection processes in global herbal medicine markets, enabling harmonized standards across borders.
- Used to resolve disputes regarding authenticity and quality of herbal medicinal products (HMPs).
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Standardization across Pharmacopeias
- The principles align with major pharmacopoeias (Chinese, European, Japanese, Korean, US), promoting interoperability and acceptance.
- Facilitate regulatory compliance and support the sustainable growth and international reputation of herbal medicinal products.
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Production and Supply Chain Management
- Provides manufacturers and suppliers with frameworks for consistent, traceable, and reliable production and distribution.
- Supports proper documentation for audits, certification, and quality assurance processes.
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Research and Innovation
- Encourages continuous improvement of quality control methods and international collaboration among stakeholders in TCM and herbal medicine sectors.
Related Standards
Implementing ISO 24825:2026 is often accompanied by familiarization with the following related standards:
- ISO 17034: General requirements for the competence of reference material producers
- ISO Guide 30: Reference material-Selected terms and definitions
- ISO 33401: Reference materials-Contents of certificates, labels, and accompanying documentation
- ISO 33403: Reference materials-Requirements and recommendations for use
- ISO 3864-2: Safety colours and safety signs-Design principles for product safety labels
- ISO 33405: Approaches for characterization and assessment of homogeneity and stability
- ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
Adhering to ISO 24825:2026 helps unify quality control processes for TCM herbal products, creating a trustworthy framework for international commerce, regulatory compliance, and ongoing innovation in herbal medicine.