In the era of quality assurance, every firm need to be quality assured so that it can achieve its quality goal. Book is prepared to emphasis on the basic techniques, methods, plans, certification procedures for quality assurance, keeping in mind the syllabus of quality assurance techniques laid by various Indian universities. Goal of this book is to provide primary and update knowledge of various quality assurance data to master of pharmacy students in the professional programme of their study.

The on statistical methods used for method development is prepared by keeping in mind the need of method development for various drug combinations. Special emphasis is given on modern techniques like SUPAC and PAT. Beside these ISO,GMP,ICH Guidelines are very well explained.

V.M.Waghulkar (Thakare): Lecturer in Quality Assurance, Vidyabharti College of Pharmacy, Amravati, Maharashtra, India

Dr. (Prof.) K.K. Tapar: Professor and Principal, Vidyabharti College of Pharmacy, Amrawati,Maharashtra, India

Dr. (Prof.) V.N. Shrikhande: Professor and Principal, IBBS College of Pharmacy, Malkapur – Buldhana,Maharashtra, India

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