(170f) QbD in Generic Drug Development: PAT Application

A generic drug product is pharmaceutically and therapeutically equivalent to a Reference Listed Drug (RLD) product. It meets the same requirements for identity, purity, quality, stability, and complies with the same rigid standards of GMP regulations for manufacturing as the innovator product. In addition, generic product development faces challenges of bioequivalence requirement and constraints of patent issues. In order to achieve the goals of QbD, FDA encourages the use of Process Analytical Technology (PAT) to promote innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. The objective of PAT is to improve understanding and efficiently control the manufacturing process. The process understanding acquired by PAT will facilitate process design, control and optimization, justify and address the limitation of the time-defined end points and reduce the risk of failure during scale-up. Well-understood processes can be designed and developed during the product development stage to consistently ensure predefined product quality. PAT initiative provides valuable guidance that can be implemented during the development of generic products to achieve a robust manufacturing process. Information gained during process development will serve as a supporting tool for the implementation of QbD and address the questions in QbR. It also helps avoid manufacturing problems and aids in troubleshooting during the life span of a product. This presentation discusses the concept of PAT and its application in product development to support ANDA filing and approval. An overview of PAT application in typical manufacturing unit operations for oral solids and its benefits in applied pharmaceutical research are provided.