GMP for Botanicals

About Book

ISBN 8190078852
Presentation Hardbound, 400 Pages
Edition Reprint 2011
Weight 0.85 Kg
Author Dr Pulok K. Mukherjee,Dr. Robert Verpoorte
Price USD 90
Availability In Stock

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 Editors - 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.

CONTENTS

 

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

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


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