Authors : Amit Kumar Sharma; Awan Kumar Pandey

Volume/Issue : Volume 10 - 2025, Issue 4 - April

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DOI : https://doi.org/10.38124/ijisrt/25apr1144

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Abstract : Quality Assurance (QA) in the industry of herbal drugs plays a crucial role in ensuring the safety, efficacy, and consistency of herbal drugs. Current Good Manufacturing Practices (cGMP) defines quality assurance as a prime system to ensure that herbal drugs meet established standards during their manufacturing life cycle. cGMP guidelines give strict regulations on every phase of manufacturing, ranging from raw material purchasing to product formulation, processing, packaging, and storage. This serves to make herbal products free of contaminants and maintain efficacy. The application of QA procedures under cGMP necessitates the utilization of controlled environments, validated procedures, and detailed documentation, with periodic inspection to verify product quality. The adoption of such practices not only guarantees consumer safety but also enhances confidence in herbal medicine due to increased product consistency and compliance with international regulatory standards. This article discusses the need for QA in the herbal drug industry, outlines the key aspects of cGMP, and emphasizes the challenge and opportunity for ensuring quality assurance in this rapidly emerging sector.

Keywords : Introduction, Overview of the Herbal Drug Industry, Importance of Quality Assurance in the Herbal Drug Industry, cGMP in the Herbal Drug Industry, Regulatory Framework for Herbal Drugs, Challenges in Implementing cGMP in the Herbal Drug Industry.

References :

1. Calixto J.B, “Efficacy, Safety, Quality control, marketing and regulatory guidelines for herbal medicines; Brazillian Journal of medical and Biological research, Volume 33 (2000), page no.179-189.
2. Edwin E., Sheeza E, Vaibhav J.and Shweta D., “Toxicology of herbs pharma times, Volume             37, page no. 27-29.
3. Agarwal A., “Critical Issues In quality Control Of Natural Products”, Pharma times, Volume 37, page no. 9-11.
4. Solescki R.S, A.Neanberthal Flower Berial Of Northern Iraq Science, 4th Edition 1975.
5. Bensky D., Chinese Herbal Materia Madica (Revised edition) 1993.
6. Baby K.L, U Zutschi, C.L Chopra, N.V Amla, “Picrorhiza an Ayurvedic Herb May Potentiate Photo Chemotherapy in Vitiliva.
7. World Health Organization, “Quality assurance of pharmaceuticals” , 1st edition reprint 2002 , volume I , published by pharma book syndicate, Hyderabad, page no.15.
8. World Health Organization, “Quality assurance of pharmaceuticals” , 1st edition reprint 2002 , volume II , published by pharma book syndicate, Hyderabad
9. Dr. Mukherjee k. pulok, “Quality Control Of Herbal Drugs”, first edition 2002, published by Business Horizons, Page no. 124, 129, 132,186, 189, 193, 214, 217, 219, 653, 658, 679, 680.
10. Malik Vijay, “Drugs and Cosmetic Act”, 1940, 7th Edition, published by Eastern Book company, page no.407.
11. Mosaic, Inc., Software Risk Management Services, 205 N. Michigan Ave., Suite 2211
12. Kokate C.K., Purohit A.P., Gokhale S.B., 25th edition, December 2003, published by Nirali prakashan, Pune, Page no. 100, 101, 102, 103, 104.
13. Bensky D., Chinese Herbal Materia Madica (Revised edition) 1993
14. Sivarajah. V.V and Belachandra I., “Ayurvedic Drugs and Their Plant Sources”, Oxford And IBH, publishing Co. Pvt. Ltd, New Delhi 50 (1994).