Abstract

Integration of Quality by Design from Product Development to API Production

Gautam Samanta, Head, Cipla Ltd

The philosophy of quality by design is all about the patients’ need. The designing, developing, and manufacturing of the product must meet those needs. Most of the innovator and few generic companies have adopted the concept of QbD in their product development. In India many pharma companies have started implementing QbD principles for all new APIs development. A perspective of QbD application for new API development will be discussed.