TEXT BOOK OF QUALITY CONTROL AND STANDARDIZATION OF HERBALS

Textbook of Quality Control and Standardization of Herbals is a comprehensive guide that delves into the critical aspects of quality control in the herbal drug industry. This book begins with basic tests for drugs, covering pharmaceutical substances, medicinal plant materials, dosage forms, and WHO guidelines for herbal drugs. It extensively discusses quality assurance, emphasizing cGMP, GAP, GMP, and GLP in traditional medicine systems. The book also includes detailed WHO guidelines on current good manufacturing practices for herbal medicines. It explores EU and ICH guidelines for quality control, safety, efficacy, and stability testing of herbal medicines. A significant section is dedicated to chromatographic techniques and their application in standardizing herbal products. The book addresses regulatory requirements, including document preparation for new drug applications, export registration, GMP, and provisions of the Drugs & Cosmetics Act. It also covers regulatory aspects specific to herbal medicines and WHO guidelines on pharmacovigilance systems. The final section compares various Herbal Pharmacopoeias and discusses the role of chemical and biological markers in the standardization of herbal products. This book is an invaluable resource for professionals and students in the field of herbal medicine, providing in-depth knowledge and guidelines for ensuring the quality and standardization of herbal products.