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. |
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. |
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