Analytical Quality by Design – A Legitimate Paradigm for Pharmaceutical Analytical Method Development and Validation

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Balaji Jayagopal, Murugesh Shivashankar (2017). Analytical Quality by Design – A Legitimate Paradigm for Pharmaceutical Analytical Method Development and ValidationMechanics, Materials Science & Engineering, Vol 9. doi:10.2412/mmse.96.97.276

Authors: Balaji Jayagopal, Murugesh Shivashankar

ABSTRACT. The apprehension and criticism on the quality and reliability of pharmaceutical products has augmented substantially, ensuing the regulatory bodies avowing the necessity of systematic principles for drug development. ICH instituted series of guidelines such as Q8, Q9, Q10 and Q11, all accentuating on implementation of systematic approaches of Quality by design (QBD) and Process Analytical Techniques (PAT). Quality by design has earned plentiful civility by formulation developers, the approach with sound scientific knowledge and early risk assessment is been accepted as an integral and imperative part of dosage form development, relishing the benefits of risk assessments on early stage and design space on the latter stage of product life cycle. However, the idea, reference, guidance and convention of practicing QBD in analytical discipline is limited, this article pronounces the ideologies and methodology of practising analytical QBD (AQBD) in analytical method development, dissolution test development and stability testing and validation design. The milestones of QBD such as Critical material attributes (CMA), Quality target product profile (QTPP), Critical quality attributes (CQA), Critical method parameters (CMP) and guidance for effective Design of experiments (DOE) differing from the conventional one factor at a time (OFAT) methodology are well explained. The software resources available for designing and interpretation of experiments, the statistical outcomes, its significance in establishing the control strategy and design space are well explained.

Keywords: AQbD, CMA, CQA, DOE, CMM, QBD.

DOI 10.2412/mmse.96.97.276

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