Rajendra Phadke1*, Dr. Amit Gosar2, Rupali Mali2, Deepesh Patil2
1J.J.T University, Churu, Jhunjhunu Road, Rajasthan -333001.
2Indoco Remedies Limited, Analytical Research & Development Department, Navi Mumbai, 400701, Maharashtra, India.
Quality by Design (QbD) refers to a holistic approach towards the drug development. In pharmaceutical industries drug development is important and critical to achieve the best quality. New drug development we should follow Quality by Design approach. Most of regulatory agency and or FDA are reviewing the drug development data. To answer such agencies and FDA we have to go towards a more scientific, risk based, holistic and proactive approach. Industrial concepts are to understand the product and manufacturing process, starting with product development, basically building quality in, not testing it. Under this concept of QbD during designing and development of a product, Now-a-days the concept of QbD can be extended to analytical techniques. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile, Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). This paper gives idea about the Pharmaceutical QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. Recently the concept has been also appreciated by different regulatory, especially by EMA (Europe Medicines Agency) and other ICH countries authorities over the globe. They are very popularly accepted as AQbD (Analytical Quality by Design) concepts by the industry.