Abstract

Background: In the present competitive situation, pharmaceutical companies all over the world are mainly focusing on the quality of product for maximum consumer acceptance and market share. Regulatory authorities are also trying to develop the pharmaceutical manufacturing process and technology, which is more concerned about the quality. Methods: Various online data and industrial requirements were reviewed and based on the today’s industrial need the paper was summarized. One of the important steps in creation of quality products was implementation of Quality by design (QbD) in pharmaceutical manufacturing. Results: The whole concept of the QbD is mainly concerned with the thorough understanding of the product and process based on knowledge and risk management. Further the process validation and continual improvement in product and process are other important aspects of QbD. After the end of 2013, the USFDA had started stressing upon the manufacturers to strictly implement the QbD. Conclusion: This review paper discusses in brief about the important stages of QbD, QbD in active pharmaceutical ingredient (API) manufacturing and QbD in case of sterile dosage form manufacturing (extractables and leachables from container closure system; and sterility).

Keywords: Active pharmaceutical ingredient, regulatory bodies, risk assessment, sterile dosage form, quality by design, USFDA.