Quality Control and Regulatory Compliance for Herbal Medication: An International Perspective

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Raveesha Peeriga Krishnaveni Manubolu

Quality Control and Regulatory Compliance for Herbal Medication

An International Perspective

Raveesha Peeriga, Krishnaveni Manubolu

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English

Routledge
30 June 2025

Dietetics & nutrition; Pharmacology; Biology, life sciences; Pharmaceutical technology

This comprehensive book provides a detailed framework for the evaluation and standardization of herbal products, promoting the safe and effective use of herbal medicines through rigorous testing and compliance with global regulatory requirements.

It begins with an overview of the fundamental tests for medicinal plant materials, followed by an in-depth look at World Health Organization (WHO) guidelines for quality control and the evaluation of commercial drugs. The book explores quality assurance practices like cGMP, GAP, GMP and GLP with a focus on traditional medicine systems, while also examining EU and ICH guidelines, stability testing and the application of chromatographic techniques in product standardization. Additionally, it addresses the preparation of documents for new drug applications, export registration and regulatory requirements, as well as providing guidelines on Pharmacovigilance and comparisons between various herbal pharmacopoeias.

A valuable reference work for professionals in the pharmaceutical industries as well as researchers and students interested in this topic.

By: Raveesha Peeriga, Krishnaveni Manubolu
Imprint: Routledge
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm,
Weight: 630g
ISBN: 9781041014126
ISBN 10: 1041014120
Pages: 244
Publication Date: 30 June 2025
Audience: College/higher education , Professional and scholarly , Primary , Undergraduate
Format: Hardback
Publisher's Status: Active

1.Basic Tests and WHO Guidelines for Quality Control of Herbal Drugs. 2.Evaluation of Commercial Crude Drugs Intended for Use. 3.Quality Assurance in Herbal Drug Industry. 4.WHO Guidelines on Current GMP for Herbal Medicines. 5.WHO Guidelines on GACP for Medicinal Plants. 6.EU and ICH Guidelines for Quality Control of Herbal Drugs. 7.Research Guidelines for Evaluating Safety and Efficacy of Herbal Medicines. 8.Stability Testing of Herbal Medicines. 9.Chromatographic Techniques in Standardization of Herbal Products. 10.Preparation of Documents for New Drug Applications and Export Registrations: GMP Requirements and Drugs & Cosmetics Act Provisions. 11.Regulatory Requirements for Herbal Medicines. 12.WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems. 13.Herbal Pharmacopoeias. 14.Chemical and Biological Markers in Standardization of Herbal Products.

Raveesha Peeriga is an Academic Professional in the Department of Pharmacognosy at V.V. Institute of Pharmaceutical Sciences, Gudlavalleru. She had received several awards. She acted as a Chairperson for BOS for Paramedicals at Krishna University. She is the Associate Fellow from the Andhra Pradesh Akademi of Sciences. She is a Life Member of various professional bodies. Krishnaveni Manubolu is an Associate Professor in the Department of Pharmaceutical Sciences at Narayana Pharmacy College, Nellore. With extensive teaching experience in Pharmacokinetics, Pharmacodynamics, and Biopharmaceutics, her research focuses on herbal formulations, natural polymer-based drug delivery systems and sustainable pharmaceutical technologies. She has published numerous scientific papers, authored book chapters and presented her work at national and international conferences. A member of professional bodies like IPA and APTI, Dr. Manubolu is dedicated to advancing research in innovative, eco-friendly therapeutics and mentoring the next generation of pharmaceutical scientists.