APPLICATION OF QUALITY BY DESIGN TO DIFFERENT ASPECTS OF PHARMACEUTICAL TECHNOLOGIESAbstract
Quality by Design [QbD] is a science based approach widely used in industry to continually monitor and improve the quality of product. It is a modern risk based strategic framework of all the aspects related to quality. ICH guidelines Q8 to Q11 summarizes all the different perspectives of quality by design system in required depth along with ways to implement it. This review in all focuses on the general terms of QbD its meanings and application along with different wide range applications of the QbD to pharmaceutical fields like Analysis, Formulation, Design and Technology development, Control Strategies etc. Also it includes a short view over the application of Various QbD tools like PAT, CAPA and HACCP in Pharmaceutical industry along with their importance in the Quality aspect of Pharmaceutical products. It also tries to cover the major aspects to be concerned while selecting the wide ranges of designs and statistical tools while employing QbD to a Particular aspect of Pharmaceutical Technology.
D. M. Patwardhan*, S. S. Amrutkar, T. S. Kotwal and M. P. Wagh
15B, Sonali Apartment, Near Vijan Hospital, Vise Mala, College Road, Nasik, Maharashtra, India.
13 February, 2017
12 April, 2017
26 April, 2017
01 September, 2017