Table of Contents

01. Basic Terminology Used In Quality Assurance 02. Total Quality Management 03. ISO 9001 : 2000 04. Environmental Management Systems and ISO 14000 05. GMP and GMP Compliance 06. Master Formula Record 07. Good Documentation Practices 08. Validation 09. Statistical Methods Used For Method Development 10. Analytical Method Development for Pharmaceutical Formulations 11. Guidelines on Audit Quality 12. ICH Harmonised Tripartite Guideline for Pharmaceutical Quality System

About the Author

Lecturer in Quality Assurance, Vidyabharti College of Pharmacy, Amravati, Maharashtra, India Professor and Principal, Vidyabharti College of Pharmacy, Amrawati, Maharashtra Professor and Principal, IBBS College of Pharmacy, Malkapur - Buldhana, Maharashtra