Sagar Kishor Savale
Department of Pharmaceutics, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur 425-405, Maharashtra, India
Mr. Sagar Kishor Savale,
Department of Pharmaceutics,
R. C. Patel Institute of Pharmaceutical
Education & Research, Shirpur, 425405,
Mobile No: 9960885333,
Email ID: firstname.lastname@example.org
Objective: In this era of competition, quality is a prime factor of importance. The principles of quality have been described by the ICH guidelines: Q8 Pharmaceutical development, Q9 Pharmaceutical quality risk management and Q10 Pharmaceutical quality system. Quality-by-design is a recent concept which has been added as an annex to ICH Q8. It is a scientific approach that helps to build in quality into the product rather than mere testing of the final product. For the implementation of QbD various tools are needed to be used which have been described briefly.
Method: Various reports were taken from review or research articles published in journals, data from various books and other online available literature. The basic principles of these three ICH guidelines with regard to quality of pharmaceutical products have been briefly discussed.
Conclusion: This is a systemic approach to design and development of the pharmaceutical formulations and manufacturing processes that ensures the predefined product quality. Pharmaceutical industry is moving towards quality. A process DOE was used to evaluate effects of the design factors on manufacture ability and final product CQA, and establish design space to ensure desired CQA. Critical material and process parameters are linked to the critical quality attributes of the product.
Keywords: QbD, design and development, ICH Q8, Pharmaceutical risk management, DOE.