Quality by design- newer technique for pharmaceutical product development

• DOI: 10.1016/j.ipha.2023.10.004
• Publication Date: 2023-10-14T07:01:00Z
• Authors: Anwar Khan; Kamran Javed Naquvi; Md Faheem Haider; Mohsin Ali Khan
• Keywords: Quality by Design; Pharmaceutical Manufacturing; Pharmaceutical Care; Pharmaceutical drug; Critical quality attributes

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