Introduction to Quality by Design for Pharmaceuticals

About the Book: Quality by design (QbD) is extensively used tool in formulation and development. QbD is a method of choice in product development for robust and quality product incorporating continuous improvement.   The objective of the book is to study the implementation of QbD and wide-ranging QbD based product development template for different formulations and analytical procedures.  The way QbD is implemented in Pharmaceutical Industry, Academicians/ Institutes are way behind in this competition. The reason being, concepts of QbD are poorly explored byPharma Researchers due to nonexistence of expertise and resources. Researchers tend to adapt moderately the principles of QbD due to inadequate understanding of QbD principles.  The use of QbD in formulation development will be advantageous to young researchers and academics. Contents: 1. Overview of QbD 2. Aspects of QbD to Product Development 3. Aspects of QbD to Analytical Method 4. DOE, PAT and RTRT 5. Question Based Review (QbR) 6. QbD as an Alternative approach to Process Validation 7. Implementation of QbD in Product Development (Case Studies) 8. Implementation of QbD in Analytical Methods (Case Studies). About the Authors: Nilesh Desai, (M.Pharm), currently is pursuing Doctor of Philosophy under the faculty of Pharmaceutical Sciences specializing in Quality Assurance Techniques from Bharati Vidyapeeth University, Pune. He has nominated and selected for Ph.D under JRF sponsored by UGC, New Delhi. He has deep understanding of Quality by design (QbD) techniques in formulation and development as per ICH guidelines. He has more than one year of industrial experience in the department of quality assurance, conducted various activities such as handling IPQA; equipment qualification of solid oral facility; handling QMS; GDP practices; vendors Qualification; Internal audit compliances; Product Quality Review (PQR); handling investigations etc. He has completed Diploma in Intellectual Property Law. He also involved in project designing and writing for various government funding agencies and also in publication of research papers. Manohar A. Potdar, M.Pharm (BITS Pilani), Ph.D. (Production Management) USA, Currently President Technical, Doshi Consultants Pvt. Ltd., Pharmaceutical Plant Design and Validation Consultants, was a professor emeritus of Pharmaceutical Sciences at Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, India. He thought Under Graduate and Post Graduate courses in Pharmaceutical Administration, Pharmaceutical Technology, Plant Design and Operations and Quality Assurance Techniques. He guided many research students in the above subjects.  He has more than forty years industrial experience gained from Indian and Multinational Companies like Merck, Burroughs Welcome, Ranbaxy, Lupin, Wockhardt, Cadila, Alkem etc. He has successfully handled various responsibilities in the area of Q.C. / Q.A., Production, Project Management besides executing International Regulatory Audits of W. H. O., TGA, MHRA, MCC and USFDA.  With his Post Graduate Diploma in Training and Development from I. S. T. D. (India) background, he has actively participated in various industrial training programmes. He is very much sought after trainer and consultant in the Pharmaceutical Industry.