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

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.

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 was acted as a Chairperson for BOS for Paramedicals, 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.