Chapter 3

Analytical quality by design for gas chromatographic method development

Rajesh Pradhan1*, Siddhanth Hejmady1*, Amit Alexander2, Gautam Singhvi1 and Sunil Kumar Dubey1*,    1Department of Pharmacy, Birla Institute of Technology and Science, Pilani, India,    2National Institute of Pharmaceutical Education and Research (NIPER-G), Ministry of Chemicals and Fertilizers, Government of India, Guwahati, India

Abstract

Quality by design (QbD) is a scientific approach in pharmaceutical product development beginning with predefined goals and utilizes scientific knowledge and risk management tools to understand the process/product and finally process control. The change in mindset of a research professional from quality by testing to QbD is a significant ...

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