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QUALITY BY DESIGN (QBD): A COMPREHENSIVE REVIEW
Pranita Kalidas Pawar*, Anuradha Kameshwar Salunkhe, Meena Kiran Jagtap, Payal Sudhakar Katkar, Shubham Ganeshrao Bhosle and Shantanu Anil Dhobale
ABSTRACT
Quality by Design is the modern approach for quality of pharmaceuticals. Quality means customer satisfaction in terms of services, product and process. QbD is best key to build a Quality in pharmaceutical products. This paper discusses pharmaceutical Quality by Design (QbD) as a way to generate high quality pharmaceuticals. Details about Quality by Design are given in addition to a list of components and tools of Quality by Design. It is based on the ICH Guidelines Q8 for Pharmaceutical development, Q9 for Quality risk management, Q10 for Pharmaceutical Quality system. Quality by Design (QbD) and describes use of Quality by Design to ensure quality of pharmaceutical analysis. Under this concepts of be throughout Keywords: CQA, CS, DS, DoE, QbD, QRM. [Download Article] [Download Certifiate] |