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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

Attaining Product Development Excellence and Federal Compliance Employing Quality by Design (QbD) Paradigms

Bhupinder Singh Bhoop* & Sarwar Beg

Introduction: The realm of developing the drug products by pharmaceutical industry has gained significant momentum towards implementing the systematic paradigms, after the implementation of ICH guidances (i.e., Q8, Q9, Q10 and Q11) imbibing the Quality by Design (QbD) principles. Pharmaceutical QbD approach to the drug product development begins with pre-defined objectives and emphasizes on the product and process understanding based upon the knowledge of sound science and quality risk management. QbD approach in particular focuses on formulation development, with an aim to design more efficacious, safe, economical and patient-compliant drug delivery systems (DDS) for unmet patient needs. Besides, QbD philosophy helps in improving the drug product quality at first place to avoid quality crisis. Other vital benefits of QbD include enhanced knowledge sharing, improved time to reach market, reduced consumer generic skepticism, and minimal post approval changes and product recalls. Owing to the innumerable benefits of QbD, it has been applicable in the diverse domains of drug product development life cycle. In this regard, the new holistic QbD-based paradigm, i.e., “Formulation by Design (FbD)”, has applicability especially in the development of drug formulations. Beyond formulation development, other vital areas of QbD application include drug substance synthesis, analytical method development, dissolution testing, manufacturing and stability testing. In a nutshell, the current book chapter describes the principles, methodology and applications of QbD in the entire product development life cycle for attaining product development excellence and regulatory compliance. 

 

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