Quality Control and Regulatory Compliance for Herbal Medication

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 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.