This book on Cleaning Validation is intended to address special considerations and issues pertaining to validation of cleaning procedures for equipment used in the manufacture of in-vitro diagstic products and reagents. This guidance has been prepared only to assist companies in the formulation of cleaning validation programs and provides guidance of developing robust systems.
The author Dr. Samar K Kundu received his Ph.D. in Organic Chemistry and D.Sc. in Bio-organic Chemistry from the Calcutta University. During his forty five years of research and development, he has published over 65 scientific papers in reputed international journals and books. He was credited with 15 US patents and 25 International patents. He has given numerous lectures in the United States and other countries. His academic career started at the University of Calcutta as a Reader in Chemistry, at the Albert Einstein College of Medicine, Bronx, New York as a Visiting Assistant Professor in Biochemistry and Immunology and at the Baylor College of Medicine, Houston, Texas in Biochemistry and Experimental Medicine as an Assistant Professor. He then began his career in Industrial Research and Development in the Diagnostic Division of the Abbott Laboratories, Abbott Park, Illinois as a Senior Scientist and later on he was inducted to the prestigious Volweiler Society as a Fellow. During the period at Abbott, he was an editor (NIH) for National Institute of Health (USA) Cholesterol Management Program, Consultant to United Nations Development Program (UNDP) in Immunodiagnostics., Visiting Professor at the Institute of Chemical Biology, Jadavpur, Kolkata, and Visiting Advisor for WHO at the National Institute of Immunology, New Delhi. He was recognized in WHO'S WHO in Marquis Frontier's in Science and Technology and in Men of Achievement, UK. Apart from his new innovation in Research and Development, he acquired extensive experience and implemented in the Quality System Regulation (QSR), Good Manufacturing Practice (GMP), Test Method Validation and others in in-vitro diagnostic products. Presently, the author is a Chief Scientist at the Sword Diagnostics and has developed new innovative technology for the ultra-sensitive detection of in-vitro diagnostic products.