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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2016)

Quality by Design (QbD) Paradigms for Robust Analytical Method Development

Bhupinder Singh1,2, Rajneet Kaur Khurana1, Ripandeep Kaur2 & Sarwar Beg1

Introduction: Since decades, the pharmaceutical product development has been accomplished through traditional trial and error approach without banking much upon the scientific principles. Invariably, this resulted in products marked with inadequate quality and consistency both. As per J.M. Juran, one of the fundamental criteria to ensure quality and consistency of the pharmaceutical products and processes is to build “quality” into the system(s). Thus, “incorporating” quality into the systems rather than merely “testing” it forms the basis of Quality by Design (QbD) paradigm. The concept of QbD was later proposed and popularized by ICH through a series of guidelines viz. Q8, Q9, Q10, Q11 and now Q12, in order to harmonize the implementation of quality practice in pharma product development. The ICH Q8(R2) guidance tersely describes QbD as, “a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. Several other leading regulatory agencies like USFDA, EMEA, MHRA, TGA, Health Canada, PMDA, MCC, ANVISA, SFDA, KFDA, etc. have been following the ICH initiatives and guidances to deliver high quality robust products. 

 

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