Risk assessment and design space consideration in analytical quality by design
P. Ramalinagm1, S. Shakir Basha1, Kalva Bhaddraya2 and Sarwar Beg3, 1Analytical Research Laboratory, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur, India, 2Swaroop Tech Consultancy, Hyderabad, India, 3Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
Abstract
Quality by design (QbD) is “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” Nowadays, QbD is a foremost prototype protocol in pharmaceutical industry ...
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