Pharmaceutical “quality by design” approach

10.4103/japtr.JAPTR_343_17 Dear Friends, Based on quality risk management, the pharmaceutical quality by design (QbD) has been emerged as a logical methodology for the development which commences with prior delineated goals and accentuates better understanding of product and process control. The basis of QbD strategy is International Conference on Harmonization guidelines. QbD approach is surfacing to augment the safe and effective drug supply to customer and assures a significant improvement in manufacturing quality performance as well. QbD development process encapsulates different aspects, namely pharmaceutical development, manufacturing process, process control, product specification, and control strategy. Initiating with pharmaceutical development, QbD approach offers systematic and multivariate experiments. Manufacturing processes are adjustable within design space and handled by company’s quality systems. Process control involves all process operations tracked. Product specifications are based on desired product performance and in general quality control strategy, i.e., risk-based control strategy. QbD presents a plethora of advantages for pharmaceutical industry as well as to customer, namely enhanced comprehension of the process, less probability of batch failure, more drug availability and less drug recall, and efficient change control and return on investments. The complete QbD process initiates with defining a target product profile which formulators can use for clinical safety and efficacy aspects. Furthermore, a prior knowledge about active pharmaceutical ingredients, excipients, and process parameters is gathered for risk assessment. Next step involves formulation designing and recognizing quality attributes of end product, which should be controlled to acquire target product quality profile. In addition, manufacturing process is designed to fabricate final product. Control strategy is also established for this complete process which includes various aspects as discussed earlier. Conclusively, it can be said that this approach gives a comparison between product quality by end-product testing and QbD approach.