Copyright (c) 2025 Ghazal Mhanna, Tanya Sharma
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Assessment of a Quality Assurance Practices in the Production of Herbal Medicines
Corresponding Author(s) : Ghazal Mhanna
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 13 No. 2 (2025): 2025 Volume -13 - Issue 2
Abstract
Background: The production of herbal medicines is increasingly significant in global healthcare, yet it faces challenges related to quality assurance (QA) practices. Issues such as contamination, adulteration, and inconsistent regulations hinder the credibility of these products in the market.
Objective: This study aims to assess the current QA practices in the production of herbal medicines, identifying challenges and proposing improvements to enhance safety and efficacy
Approach: A mixed-methods research design was employed, combining qualitative and quantitative approaches. Qualitative data were gathered through case studies and interviews with industry experts, regulatory authorities, and manufacturers, while quantitative data were collected via structured surveys and laboratory testing of samples. The study involved 57 manufacturers and analyzed 30 samples, focusing on adherence to established quality standards
Result: The findings revealed that 70% of medium-scale operations met quality standards, but small-scale units faced significant financial constraints, with 60% lacking funds for necessary QA upgrades. The study highlighted the need for scale-specific interventions to improve QA practices and market trust.
Conclusion: The research underscores the importance of regulatory harmonization, technological adoption, and resource support to ensure the safety and efficacy of herbal medicines, ultimately benefiting the 80% of the global population that relies on these products.
Keywords
- Ansari, S. (2021). Overview of traditional systems of medicine in different continents. In Preparation of Phytopharmaceuticals for the Management of Disorders (pp. 431-473). Academic Press.
- dos Reis Serra, C. H. (2007). Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Revista Brasileira de Ciências Farmacêuticas, 43(4), 661-662.
- Moreira, D. D. L., Teixeira, S. S., Monteiro, M. H. D., De-Oliveira, A. C. A., & Paumgartten, F. J. (2014). Traditional use and safety of herbal medicines. Revista Brasileira de Farmacognosia, 24(2), 248-257.
- Ahmad, M. U. D., Sarwar, A., Najeeb, M. I., Nawaz, M., Anjum, A. A., Ali, M. A., & Mansur, N. (2013). Assessment of microbial load of raw meat at Abattoirs and retail outlets.
- Baker, A. J. M., & Walker, P. (1989). Physiological responses of plants to heavy metals and the quantification of tolerance and toxicity. Chemical Speciation & Bioavailability, 1(1), 7-17.
- Morsy, N. (2014). Phytochemical analysis of biologically active constituents of medicinal plants. Main Group Chemistry, 13(1), 7-21.
- Hassen, H. K., Mekasha, Y. T., Tegegne, A. A., & Ozalp, Y. (2024). A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines. Frontiers in Medicine, 11, 1472495.
- Hossain, C. M., Gera, M. E. E. T. A., & Ali, K. A. (2022). Current status and challenges of herbal drug development and regulatory aspect: a global perspective. Asian J. Pharm. Clin. Res, 15, 31-41.
- World Health Organization. (2024). Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, Volume 1. Good practices and related regulatory guidance. World Health Organization.
- Schulz, A., & Bohnet-Joschko, S. (2023). Expanding the horizon of patient informed consent: beyond the written word.
- Surmiak, A. D. (2018). Confidentiality in qualitative research involving vulnerable participants: Researchers' perspectives. In Forum Qualitative Sozialforschung/Forum: Qualitative Social Research (Vol. 19, No. 3). DEU.
- Israel, M. (2014). Research ethics and integrity for social scientists: Beyond regulatory compliance.
References
Ansari, S. (2021). Overview of traditional systems of medicine in different continents. In Preparation of Phytopharmaceuticals for the Management of Disorders (pp. 431-473). Academic Press.
dos Reis Serra, C. H. (2007). Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Revista Brasileira de Ciências Farmacêuticas, 43(4), 661-662.
Moreira, D. D. L., Teixeira, S. S., Monteiro, M. H. D., De-Oliveira, A. C. A., & Paumgartten, F. J. (2014). Traditional use and safety of herbal medicines. Revista Brasileira de Farmacognosia, 24(2), 248-257.
Ahmad, M. U. D., Sarwar, A., Najeeb, M. I., Nawaz, M., Anjum, A. A., Ali, M. A., & Mansur, N. (2013). Assessment of microbial load of raw meat at Abattoirs and retail outlets.
Baker, A. J. M., & Walker, P. (1989). Physiological responses of plants to heavy metals and the quantification of tolerance and toxicity. Chemical Speciation & Bioavailability, 1(1), 7-17.
Morsy, N. (2014). Phytochemical analysis of biologically active constituents of medicinal plants. Main Group Chemistry, 13(1), 7-21.
Hassen, H. K., Mekasha, Y. T., Tegegne, A. A., & Ozalp, Y. (2024). A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines. Frontiers in Medicine, 11, 1472495.
Hossain, C. M., Gera, M. E. E. T. A., & Ali, K. A. (2022). Current status and challenges of herbal drug development and regulatory aspect: a global perspective. Asian J. Pharm. Clin. Res, 15, 31-41.
World Health Organization. (2024). Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, Volume 1. Good practices and related regulatory guidance. World Health Organization.
Schulz, A., & Bohnet-Joschko, S. (2023). Expanding the horizon of patient informed consent: beyond the written word.
Surmiak, A. D. (2018). Confidentiality in qualitative research involving vulnerable participants: Researchers' perspectives. In Forum Qualitative Sozialforschung/Forum: Qualitative Social Research (Vol. 19, No. 3). DEU.
Israel, M. (2014). Research ethics and integrity for social scientists: Beyond regulatory compliance.