Analytical Quality by Design (AQbD) : A New Horizon For Robust Analytics in Pharmaceutical Process and Automation
Keywords:AQbD, PAT, MODR, DoE, ATP, CMC, CQA, QTPP, FDA, Risk management
The apprehension and criticism on the quality and reliability of pharmaceutical products has augmented substantially in recent times, ensuing the regulatory bodies affirming the necessity of systematic principles for drug development. ICH has instituted series of guidelines such as Q8, Q9, Q10 and Q11, all of them stressing on the implementation of systematic approaches of Quality by Design (QbD) and Process Analytical Techniques (PAT) for pharmaceutical product and process design. QbD has earned plentiful consideration by formulation developers, the approach with sound scientific knowledge and early risk assessment is been accepted as an integral and imperative part of pharmaceutical dosage form development, relishing the benefits of risk assessments on early sage and design space on the later stage of product life cycle. However, the idea, reference, guidance and way of practicing QbD in the analytical field termed as AQbD are limited wherein no concrete regulatory requirement have been spelt out yet. In this article, the key milestones of QbD such as Critical Material Attributes (CMA), Quality Target Product Profile (QPP), Critical Quality Attributes (CQA), Critical Method Parameters (CMP) and the guidance for the effective Design of Experiments (DoE) differing form the conventional One Factor At a Time (OFAT) methodology has been explained. Unlike current methods, methods developed using AQbD approach reduces the number of Out of Specification (OOS) and Out of Trend (OOT) results due to robustness of the method within the Method Operable Design Region (MODR).
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Agilent solutions for Qualiy by design implemenaion in Pharmaceuical development
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