QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY: A CONCEPTUAL REVIEW OF CURRENT APPROACH AND ITS LIMITATIONS

Quality by Design (QbD) brings quality to the fore from the very beginning of the product development and manufacturing process, improving efficiency as a result. After all, testing products at the end of the manufacturing process limits your options for correction. Quality cannot be tested into a product; it needs to be infused into it, by design. Combined with Process Analytical Technology (PAT), QbD enables forward-looking companies to move away from traditional quality approaches and instead employ systematic, data-driven strategies to deliver quality outcomes. [1,2]. In this review, our analysis reveals the following tools as the frequently adopted for conducting each activity: Quality Target Product Profile (QTPP), Critical Material Attributes (CMA), Critical Quality Attributes (CQA), Critical Process Parameter (CPP), Reference Listed Drug (RLD), Design Space, Design of Experiments (DoE), Risk Assessment (RA) and Mitigation/Minimization. Quality by Design, Formulation by Design, Analytical QbD. FDA initiative on process analytical technology. PAT as driver for improving quality and reducing costs: QbD, QA, QC and GAMP, PAT Guidance, Standards and Regulatory Requirements. The present paper deals on these two terms QbD and PAT.

Keywords: Quality by Design; Risk Assessment; Design of Experiments; PAT; Design Space; ICH Q8