Introduction to Quality by Design for Pharmaceuticals - Desai, Nilesh; Potdar, Manohar A
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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…mehr

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Produktbeschreibung
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.
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Autorenporträt
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.