GMP for Botanicals

EDITOR’S: Robert Verpoorte and Pulok K. Mukherjee
PUBLISHER: Business Horizons
ISBN: 9798190078855
YEAR: 2003 – First Edition
PAGES: 385
SIZE: 18 X 24.5 X 2.5 cm.
BINDING: Hard
LANGUAGE: English

ABOUT THE BOOK: The long awaited book on Good Manufacturing Practices with a Nuts-and-Bolts approach to provide a no-nonsense and practical support for the industries and laboratories in the field of botanicals.
In this edited volume, leading academics and industrial scientists have contributed with various aspects of Good Manufacturing Practices (GMP) and novel methods for quality production of botanicals, their standardization, international regulatory status and related approaches for their implementation in the field of herbal medicines.
The vast of body of knowledge incorporated in this volume will be useful to herbal medicine manufacturers, faculties of pharmacy as well as the serving scientists engaged in Pharmacognosy, phytochemistry and drug development from natural products.
• Provides guidelines on GMP for botanicals
• Provides a practical view on the production of botanicals
• Explains the quest for GMP in herbal medicines
• Identifies critical areas in the production and quality control of botanicals
• Explains regulatory affairs governing herbal medicine usage of different countries
• Focus on quality control and standardization of botanicals in the ambit of GMP
• Newer aspects for evaluation of botanicals with mass spectroscopy, capillary electrophoresis and other newer techniques
• Explain proven strategies with useful examples in the GMP for botanicals
• Extensive references to each chapters in his context of herbal GMP

ABOUT THE EDITOR’S:
1. Prof. Dr. Robert Verpoorte is the Head of the Department of Pharmacognosy/Plant Cell Biotechnology at the Leiden/Amsterdam Center for Drug Research, University of Leiden, The Netherlands. He is author/co-author of 460+ scientific papers and 3 books. He is member of the Editorial Advisory Board of the Journal of Natural Products, Medicinal and Aromatic Plants Abstracts, Biotechnology Letters, Plant Cell Tissue and Organ Culture, Annals of Magnetic Resonance, Mahidol University Journal of Pharmaceutical Sciences, Phytothιrapie, Journal of Natural Remedies, Transgenic Research and Fitoterapia, Associate Editor of Phytochemical Analysis, Editor of Journal of Ethnopharmacology and Phytochemical Reviews. He has served as vice-chairman and chairman of the committee of the Phytochemical Society of Europe.
2. Dr. Pulok K Mukherjee is a well-known personality in the field of botanical research. He is working at the Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India and is involved in research on screening, isolation, formulation, evaluation and standardization of botanicals. He has to his credit over 100 research papers and one patent. He is the author of best-selling book QUALITY CONTROL OF HERBAL DRUGS – An Approach To Evaluation Of Botanicals. He is member of the Editorial Advisory Board of the Journal of Natural Remedies, J. Pharmaceutical Education, J. Pharmaceutical Research, Phytotherapy Research, Oriental Pharmacy and Experimental Medicine. He is an active member of various international organizations including, Drug Information Association (DIA), USA, International Society of Ethnopharmacology (ISE), Phytochemical Society of Europe (PSE) etc.

CONTENTS:
Preface
Contributors
About the Editors

CHAPTER – 1: DEVELOPMENT OF NATURAL PRODUCTS
Robert Verpoorte
    Introduction
    Plant Secondary Metabolites
    Development of New Natural Products
    Production and Quality Control
    Conclusions
    References

CHAPTER – 2: LEGAL SYSTEMS AND REGULATIONS
Willem K Scholten
    Introduction
    Differences in Legal Systems
    Points to Consider with Herbal Regulations
    National and Regional Regulations
    Worldwide Harmonization
    References

CHAPTER – 3: OVERVIEW OF GLOBAL REGULATORY STATUS
KK Bhutani and HR Jadhav
    Introduction
    Regulatory Status
    Summary and Conclusion

CHAPTER – 4: REGULATORY CONTROLS ON PHYTOMEDICINES
VB Desai, S Badami, Giriraj T Kulkarni and B Suresh
    Introduction
    Standardization of Phytomedicines
    Standards for Herbal Dosage Forms
    Standardization of Herbal Products - Indian Scenario
    Current Regulatory Controls on Phytomedicines
    Conclusion
    References

CHAPTER – 5: HERBAL MEDICINE REGULATIONS IN RUSSIA
Severtsev VA, Makarov VG, Shikov AN and Pozharitskaya ON
    Introduction
    Herbal Medicine Industry in Russia
    Regulating Production of Herbal Medicines in Russia
    Licensing for Manufacture of Herbal Medicines
    Quality Standards of Herbal Medicines in Russia
    Discussions
    References

CHAPTER – 6: PRODUCING QUALITY BOTANICALS THROUGH GMP
Rajeev K Sharma
    Herbal Drugs and ISM Pharmaceuticals
    Quality of Herbal Drugs
    Basic Perception of Quality
    Quality Variation Factors in Herbal Drugs
    Historical Background
    Status and Applicability of GMP Regulations
    Objectives of GMP
    Salient Features of GMP Under Schedule - T For ISM Drugs
    Components of GMP (Schedule -T)
    GMP Provisions: A Bird Eye View
    Quality Control Vis-ΐ-Vis Quality Assurance
    Quality Control of Herbal Drugs
    Methodologies/Standardization of Herbal Drugs
    References

CHAPTER – 7: GMP REQUIREMENTS IN INDIAN SYSTEMS OF MEDICINE
Pulok K Mukherjee
    Introduction
    Regulation and Registration of Herbal Medicines
    Need for GMP for Botanicals
    GMP in Indian Systems of Medicine
    General Requirements for GMP of ASU Drugs
    Raw Materials for ASU Drugs
    Quality Assurance And Quality Control
    Documentation in The GMP for ASU Drugs
    Self-Inspection and Quality Audits
    Implementation of GMP for ASU Drugs
    Conclusion
    References

CHAPTER – 8: GUIDANCE ON GMP FOR PHYTOMEDICINES
JPS Kohli
    General
    Personnel
    Buildings and Facilities
    Sanitation
    Equipment
    Maintenance
    Computer Systems Validation
    Calibration
    Warehousing
    Quality Manual
    Site Master File
    References

CHAPTER – 9: FORMULATION TECHNIQUES IN AYURVEDA
KS Jayashree
    Introduction
    Evam Prakruthihi (Identification)
    Eavam Guna (Qualities)
    Eavam Prabhavam (Empirical Knowledge)
    Asmin Deshejathaha (Ecology)
    Asmin Rituvevam Grahitham (Season of Collection)
    Anaya Matraya Nihitam (Posology)
    Asmin Vyadhou Prayuktam (Suitable for this Disease)
    Etavamtham Dhoshamapakarshati (Effect on the Doshas)
    Shodhana (Purification Procedures)
    Tests for Perfect Processing
    Conclusions
    References

CHAPTER – 10: QUEST FOR GMP FOR THE PRODUCTION OF BOTANICALS
Pulok K Mukherjee and BP Saha
    Introduction
    Botanicals and their Assessment
    Good Agricultural Practices
    Good Practices in Collection of Plant Materials
    Primary Processing of Herbal Products
    Documentation Required
    Other Guidelines for Quality Assurance of Herbal Drugs
    References

CHAPTER – 11: DEVELOPMENT OF AYURVEDIC MEDICINE
Shanthkumar Lucas
    Introduction
    Ayurvedic Education and Research
    Drug Development Through Ayurveda

CHAPTER – 12: MANUFACTURING AND QUALITY CONTROL OF AYURVEDIC AND HERBAL PREPARATIONS
J Singh, GD Bagchi and SPS Khanuja
    Introduction
    Processing of Ayurvedic Drugs
    Bioprospection, Drug Development and Pharmacogenomics
    Legislature in India
    Good Manufacturing Practices
    Standardization and Quality Control
    Chemical and DNA Fingerprinting of Herbal Drugs
    Safety and Efficacy Evaluation
    References

CHAPTER – 13: ENSURING SAFE USE OF HERBAL DRUGS
MK Chattopadhyay
    Introduction
    Problems
    Toxicity
    Quantitative and Qualitative Variation
    Interaction with Other Drugs
    Adulteration
    Paucity of Information
    Regulations in Different Countries
    Conclusion
    References

CHAPTER – 14: QUALITY AND SAFETY OF BOTANICALS
K Sadasivan Pillai and V Amalan Stanley
    Introduction
    Process Validation
    Safety Evaluation of Drugs
    References

CHAPTER – 15: ANALYSIS OF SOUTH PACIFIC HERBAL DRUGS
Subramaniam Sotheeswaran
    Introduction
    Herbal Drugs of Commercial Importance
    Future Directions
    Conclusion
    References

CHAPTER – 16: QUALITY CONTROL OF BOTANICALS CONTAINING ESSENTIAL OILS
A Zaenglein
    Introduction
    Parameters and Methods
    GMP Specifications
    Problem Definition
    Experimentals
    Results and Discussion
    Conclusions
    References

CHAPTER – 17: MASS SPECTROMETRY APPLICATIONS IN HERBAL MEDICINE ANALYSIS
Pierluigi Mauri and Piergiorgio Pietta
    Introduction
    Instrumental
    Quality Control of Medicinal Plants
    Qualitative Analysis
    Quantitative Analysis
    Medicinal Plant Analysis by MS
    Conclusions
    References

CHAPTER – 18: CAPILLARY ELECTROPHORESIS IN HERBAL MEDICINE ANALYSIS
Piergiorgio Pietta and Claudio Gardana
    Introduction
    Analysis of Medicinal Plants
    Experimental Procedure
    Conclusions
    References

CHAPTER – 19: PHARMACOLOGICAL EVALUATION
A Subramonium
    Introduction
    Problems Facing Development Of GMP
    Pharmacological Evaluation Of Herbal Drugs
    Pharmacological Standards For Herbal Drugs
    Conclusions
    References

CHAPTER – 20: CLINICAL TRIALS OF HERBAL MEDICINES
Carmen Tamayo
    Introduction
    Basic Concepts
    Classification of RCTsRCTs Methodology Concepts
    Herbal Medicine Concepts
    Herbal Medicine Research Methodology
    Issues in Clinical Research of Herbal Medicines
    Good Protocol Characteristics
    Clinical Trial Development
    Challenges of Herbal Medicine''s RCTs
    IND Requirements in the Evaluation of Herbal Products
    References

CHAPTER – 21: ROLE OF BIOASSAYS IN DEVELOPMENT OF NATURAL PRODUCTS
Amit Agarwal and Prasanth D Souza
    Introduction
    Classification of Bioassays
    Use of Bioassays in Quality Control
    Use of Bioassays to Assess Combinational Activity
    Use of Bioassays in Stability Testing
    Overview
    References

Index
Acknowledgement