Quality by Design Approch Based in Analytical Method Validation

Abstract

Quality by design is used to designing and developing a formulation and manufacturing process to ensure a predefined quality and this process to enhance capability of process and reduce product variability and defects by increasing product and process design understanding and control. According to guidelines of International conference on Harmonization, Q8, Q9, Q10 are the foundations of Quality by design. Q8 for Pharmaceutical development to design quality of product, Q9 for Quality risk management (QRM) to identify and minimize the risk, Q10 for Pharmaceutical quality system is a management system to give assurity of product quality. Elements of quality by design include Quality Target Product Profile [QTPP] is identify critical Quality Attributes [CQAs] of drug product, product design and identify Critical Material Attributes [CMAs], process design and identify Critical Process Parameters [CPPs], The Control strategy consists of the process and input material control and monitors the design space to identify the final product that ensures the desired quality, process capability and continued improvement. Design of experiment [DoE] is gain to maximum information from a minimum number of experiments and the FDA intimate significance of the quality by granting Process Analytical Technology [PAT] as a framework for brand new pharmaceutical development, manufacturing and the quality assurance. goal of PAT to enhance understanding, control and safety of the manufacturing process and principle of PAT is quality cannot be tested into final product it should be built in or should be by design. Analytical quality by design [AQbD] is also an inherent part of the product development control strategy beside with other parameters such as process parameters, material attributes, equipment operating conditions, in-process controls, and finished product specifications.