Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

[1]  I. Molnár,et al.  Expanding the term "Design Space" in high performance liquid chromatography (I). , 2011, Journal of pharmaceutical and biomedical analysis.

[2]  Barbara Brunetti,et al.  About acceptance and rejection zones as defined in the EURACHEM/CITAC Guide (2007) “Use of uncertainty information in compliance assessment” , 2010 .

[3]  H. Khan,et al.  Pharmaceutical Technology , 2007 .

[4]  Frederick G Vogt,et al.  Development of quality-by-design analytical methods. , 2011, Journal of pharmaceutical sciences.

[5]  X. Yang,et al.  Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities. , 2011, Journal of chromatographic science.

[6]  Alan Hall,et al.  Organic Process Research and Development , 1997 .

[7]  Sandra Furlanetto,et al.  Application of quality by design to the development of analytical separation methods , 2012, Analytical and Bioanalytical Chemistry.

[8]  Devesh A. Bhatt,et al.  "QbD APPROACH TO ANALYTICAL RP­HPLC METHOD DEVELOPMENT AND ITS VALIDATION , 2011 .

[9]  K. Basavaiah,et al.  Implementation of Quality by Design for the Development and Validation of Pioglitazone Hydrochloride by RP-UPLC with Application to Formulated Forms , 2012 .

[10]  K. Basavaiah,et al.  Quality by Design Approach for the Development and Validation of Glipizide, an Antidiabetic Drug, by RP-UPLC with Application to Formulated Forms and Urine , 2013 .

[11]  Imre Molnár,et al.  Quality by design in pharmaceutical analysis using computer simulation with UHPLC , 2014 .

[12]  AR Chabukswar,et al.  Six Sigma: Process of Understanding the Control and Capability of Ranitidine Hydrochloride Tablet , 2011, Journal of young pharmacists : JYP.

[13]  E. Kellenbach,et al.  Applying QbD Principles To Develop a Generic UHPLC Method Which Facilitates Continual Improvement and Innovation Throughout the Product Lifecycle for a Commercial API , 2013 .

[14]  I. Molnár,et al.  Aspects of the "Design Space" in high pressure liquid chromatography method development. , 2010, Journal of chromatography. A.

[15]  I. Molnár,et al.  Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation. , 2012, Journal of chromatography. A.

[16]  I. Krull,et al.  A Quality-by-Design Methodology for Rapid LC Method Development, Part III , 2008 .

[17]  Orin J. Percus.  Aspects of A , 1997 .

[18]  G. L. Reid,et al.  REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT IN AN ANALYTICAL QUALITY BY DESIGN FRAMEWORK , 2013 .

[19]  M. Jadhav,et al.  Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Propafenone Hydrochloride in Tablet Dosage Form , 2013 .