Dedication
 
((Einstein quotation))
 
Preface
 
About the Editor
 
Biographies of Contributing Authors
 
Editorial Notes
 
Dedication
 
Acknowledgments

Chapter 1 - Drug Regulations and the Pharmaceutical Laboratories
 
1.1 Introduction
 
1.2 Food and Drug Administration: Role and its Regulations
 
1.2.1 Code of Federal Regulations
 
1.2.2 FDA Guidance Documents
 
1.2.3 FDA Manual of Policies and Procedures
 
1.3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and its Role
 
1.3.1 ICH background
 
1.3.2 ICH Structure
 
1.3.3 ICH Organization
 
1.3.3.1 Steering Committee
 
1.3.3.2 Global Cooperation Group
 
1.3.3.3 MedDRA Management Board
 
1.3.3.4 Working Groups
 
1.3.3.5 Secretariat
 
1.3.3.6 Coordinators
 
1.3.4 ICH Topics
 
1.4 Pharmaceutical Analysis
 
1.4.1 Analytical Testing
 
1.4.2 Interaction Between the Analytical Development Department and Other Functional Areas
 
1.4.3 Drug Development Process
 
1.4.3.1 Toxicological Phase
 
1.4.3.2 Investigational New Drug
 
1.4.3.3 Clinical Phase
 
1.4.3.4 Registration Phase
 
1.4.3.5 New Drug Application
 
1.4.3.6 Post-Approval Phase
 
References
 
List of Abbreviations

Chapter 2 - Good Manufacturing Practices (GMPs) and the Quality Systems
 
2.1 Introduction to Good Manufacturing Practices
 
2.2 Objectives of GMPs
 
2.2.1 Definitions
 
2.2.2 Organization of 21 CFR Regulations
 
2.3 Personnel Qualifications and Responsibilities - Subpart B
 
2.3.1 Responsibilities of Quality Control Unit
 
2.3.2 Personnel Qualifications and Responsibilities
 
2.4 Equipment - Subpart D
 
2.4.1 Metrology Functions
 
2.4.2 Qualification Phases
 
2.5 Laboratory Controls - Subpart I
 
2.5.1 General Requirements
 
2.5.2 Testing and Release for Distribution
 
2.5.3 Stability Program
 
2.5.4 Retention Program
 
2.6 Records and Reports
 
2.7 Pharmaceutical Quality
 
2.7.1 Quality Manual
 
2.7.2 Quality Risk Management
 
2.7.3 Product Quality Review
 
2.7.4 Pharmaceutical Quality Systems
 
References
 
List of Abbreviations

Chapter 3 - Analytical Techniques Used in the GMP Laboratory
 
3.1 Introduction
 
3.2 Definitions
 
3.2.1 Raw Data and Analytical Data
 
3.2.2 Analyses
 
3.2.3 Analytical Documents
 
3.3 Basic Laboratory Procedures
 
3.3.1 Balances
 
3.3.2 Volumetric Glassware
 
3.3.3 Potentiometry (ion-selective electrode) and pH Test
 
3.3.4 The Density Test
 
3.3.5 The Friability Test
 
3.3.6 The Hardness Test
 
3.3.7 The Titration Test
 
3.3.8 The Karl Fischer Titration - Water Determination
 
3.3.9 Loss on Drying
 
3.3.10 Residue on Ignition/Sulfated Ash
 
3.3.11 Thermal Gravimetric Analysis
 
3.3.12 Differential Scanning Calorimetry
 
3.3.13 The Disintegration Test
 
3.3.14 Particulate Matter
 
3.3.15 Osmolality
 
3.4 Chromatography
 
3.4.1 High-Performance Liquid Chromatography
 
3.4.1.1 Normal Phase Separation Mode
 
3.4.1.2 Reversed-Phase Separation Mode
 
3.4.1.3 Other HPLC Separation Modes
 
3.4.2 Ultra-High Pressure Liquid Chromatography
 
3.4.3 Detectors of