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Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products
Jung-Hoon Kim1, Kyungjin Lee2, Ui Min Jerng3
1Division of Pharmacology, School of Korean Medicine, Pusan National University, Yangsan 50612, Republic of Korea.
Evidence-Based Complementary and Alternative Medicine : Ecam
|November 28, 2019
Summary
Ensuring consistent quality in herbal products is complex due to their variability. This review compares global stability testing regulations for herbal products, aiding international quality assessment harmonization.
Area of Science:
- Pharmacology
- Herbal Medicine Quality Control
- Regulatory Science
Background:
- Achieving consistent quality in herbal products is challenging due to inherent variability and complex physicochemical properties.
- Regulatory bodies worldwide have established guidelines for stability testing of herbal products under specified storage conditions.
- Stability testing is crucial for ensuring the therapeutic efficacy and safety of drug products.
Purpose of the Study:
- To compare global regulations and guidelines for stability testing of finished herbal products.
- To provide an overview of the current international landscape for herbal product quality assessment.
- To facilitate the harmonization of quality control standards for herbal medicines.
Main Methods:
- A comparative analysis of stability testing parameters and procedures for herbal products.
- Review of guidelines and regulations from 5 global authorities (ASEAN, EEC, EMA, ICH, WHO) and 15 countries.
- Inclusion of physical, chemical, and biological stability tests, along with storage conditions (temperature, humidity).
Main Results:
- Detailed examination of testing parameters and methods across various international regulatory frameworks.
- Identification of commonalities and differences in stability testing requirements for different herbal product dosage forms.
- Compilation of testing conditions (long-term, accelerated, intermediate) specified by global authorities and countries.
Conclusions:
- Comparative analysis of global stability testing regulations is essential for international harmonization of herbal product quality.
- Understanding the global situation regarding herbal product quality testing aids in regulatory alignment.
- This review serves as a foundational resource for assessing and improving global standards for herbal medicine stability testing.
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