World Health Organization : Year 2001 ; The Special Programme for Research and Training in Tropical Diseases Prd Glp 01.2: Handbook Good Laboratory Practice (Glp)

By Deborah Kioy

Book Id: WPLBN0000193222
Format Type: PDF eBook:
File Size: 1.19 MB
Reproduction Date: 2005

Title:	World Health Organization : Year 2001 ; The Special Programme for Research and Training in Tropical Diseases Prd Glp 01.2: Handbook Good Laboratory Practice (Glp)
Author:	Deborah Kioy
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Kioy, Dr, B. D. (n.d.). World Health Organization : Year 2001 ; The Special Programme for Research and Training in Tropical Diseases Prd Glp 01.2. Retrieved from http://gutenberg.cc/

Description
Medical Reference Publication

Excerpt
1. INTRODUCTION TO THE TDR HANDBOOK ON GLP GENERAL INTRODUCTION The need for application of quality standards in drug research, development and testing : the situation of developing countries and the role of TDR Tropical diseases are a major public health problem in developing countries. For many of these diseases there are no new, effective and affordable medicines, while older therapeutic agents are beginning to lose ground on account of the emergence of resistance against them. The multinational pharmaceutical companies have not traditionally focused on these indications in their development programmes, which is why WHO has created research and development programmes in a number of priority areas such as malaria. WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) commissions studies to be conducted in the areas most affected by such diseases. If such programmes are to be successful – that is to say, result in the successful registration of effective and safe new drug products – it is evident that the component studies must comply with current quality standards in order to ensure the quality, reliability and integrity of data and to protect public health. National regulations require therefore that internationally accepted rules, i.e. good manufacturing practice, good laboratory practice, and good clinical practice, are followed in the respective stages of the development and life cycle of a drug product (see the diagram on product development, page 7).

Table of Contents
TABLE OF CONTENTS FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 CHAPTER 1. INTRODUCTION TO THE TDR HANDBOOK ON GLP . . . . . . . . . . . . . . . . . . 5 GENERAL INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 The need for application of quality standards in drug research, development and testing: the situation of developing countries and the role of TDR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 The drug development process and the non-regulated vs. Regulated areas. . . . 7 INTRODUCTION TO GLP AND ITS APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . 9 The history of GLP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 What is GLP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2. GOOD LABORATORY PRACTICE TRAINING . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 THE FUNDAMENTAL POINTS OF GLP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Characterization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Quality assurance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19