Full Description
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.
Contents
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.
