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GMP for Botanicals Product Image

GMP for Botanicals

  • ID: 1267769
  • January 2003
  • 400 Pages
  • Business Horizons

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

Note: Product cover images may vary from those shown

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-À-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
D 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 RCTs
- RCTs Methodology Concepts
- Herbal Medicine Concepts
- Herbal Medicine Research Methodology
- Issues in Clinical Research of Herbal Medicines
- Good Protocol Characteristics
- Clinical Trial Development

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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, Phytothérapie, 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.

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.

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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