A Quality by design a common understanding of the concept of ICH guideline Q8, Q9 and Q10 and treated as an essential in the process of formulation. The present investigation starts with the identification of TPP and CQA which involves risk assessment in their final selection process. In the product design space the product characteristic involves identification of critical product attributes which ultimately resulted in the selection of CPP that is process design space. This identified control strategy requiring continuous monitoring and updating the process requirements. Validation is one of the important steps in achieving and maintaining the quality of the final product which has been taken into consideration in the present research work. Important parameters were validated. The dosage form in the present research work is a new generation NSAID’s which is commonly used for relief of pain caused during post operative surgical procedure. Therefore in selecting target product profile risk of incomplete bioavailability due to tablet or oral dosage form as taken into consideration. The quality by design principle and tools demonstrated in the present research work will play an important role in understand- ing and creating opportunities for investigation and developing control strategy in pharmaceutical development process.
