In this era of quality assurance, it is imperative that every organization strives for quality in order to achieve its objectives. This book has been prepared with the aim of providing basic techniques, methods, plans, and certification procedures for quality assurance, with the syllabus laid out by various Indian universities in mind. The primary goal of this book is to provide master of pharmacy students with up-to-date knowledge of various quality assurance data, as well as the skills necessary to develop methods for a variety of drug combinations. Special emphasis is placed on modern techniques like SUPAC and PAT, as well as a thorough explanation of ISO, GMP, and ICH guidelines.

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