Quality by design- newer technique for pharmaceutical product development

Abstract

Regulatory bodies are nowadays concerned with pharmaceutical drug products' safety, efficacy, and quality. Quality is the priority of all regulatory bodies, it is a high priority for the triple P factor (patient, pharmacist, and physician). It links pharmaceutical industries and regulatory authorities for designing, manufacturing, and consistently delivering safe and efficient products. It mainly focuses on fabricating and designing formulations and manufacturing processes to ensure predefined product quality. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems. Some of the important effective elements of QbD are to define the target profile that what is the requirement of the pharmacist, physician, and patient (TPP-QTPP) then measuring the criticality for achieving that target (CQA) and analyzing the risk assessment of variables associated with materials and controlling processes to produce consistent quality over time. The objective of this review is to discuss the concept of Quality by Design and describe its application in pharmaceutical product development.