Asian Journal of Research in Pharmaceutical Sciences

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A Review on:Quality by Design (QbD)


Affiliations
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India
2 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, India
3 MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, India
     

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Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design and describe how it can be used to ensure pharmaceutical quality. Quality cannot be tested into products but quality should be built in by design. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product profile (TPP), Target product Quality profile (TPQP) and identify Critical quality attributed (CQA).On the basis of this we can design the product formulation and the process to meet the product attributes. These leads to recognize the impact of raw material Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT)

Keywords

Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT).
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  • Sangshetti JN, Zaheer Z, Mahaparale PR and Chitlange SS. Quality by design (QbD) in pharmaceuticals. Unique Publication, Aurangabad. 1st edition; 2015: 20

  • Gawade A, Chemate S and Kuchekar A. Pharmaceutical Quality by Design: A New Approach in Product Development. Research and Reviews: Journal of Pharmacy and Pharmaceutical Sciences. 2013; 2:5-11.

  • Juran JM. On quality by design the new steps for planning quality into goods and services New York free press. 1992; 1-2.

  • Food and Drug Administration. Final Report on Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach. [Online] Available at: http://www.fda.gov/ cder/ gmp/ gmp 2004/ GMP_ final report 2004.htm. Accessed 10 March 2016.

  • Jain S. Quality by Design (QbD): A Comprensive understanding of implementation and challenges in pharmaceutical development. Int J of Pharm Pharma Sci. 2014; 6:29-35.

  • US Food and Drug Administration. Guidance for industry: Q8 (R2) pharmaceutical development. US Department of Health and Human Service, FDA, Rockville, MD; 2009.

  • Looby M, Ibarra N, Pierce JJ, Buckley K, O'Donovan E, Heenan M, et al. Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein. Biotechnology Progress. 2011; 27(6): 1718-29.

  • Nadpara NP, Thumar RV, Kalola VN, Patel PB. Quality by Design: A complete review. Int. J. Pharm. Sci, Rev Res. 2012; 2: 20-8.

  • Roy S, Quality by design: A holistic concept of building quality in pharmaceuticals. International Journal of Pharmaceutical and Biomedical Research .2012; 3 (2): 100-108.

  • Chang RK, Raw A, Lionberger R, Yu L. Generic development of topical dermatologic products, part II: quality by design for topical semisolid products. AAPS J. 2013; 15(3): 674.

  • McConnell J, McGarvey B, Nunnally B. Quality risk management and variability reduction. Journal of Validation Technology. 2011:12-6.

  • Mollah H, Baseman H, Long M. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing: Wiley; 2013.

  • White E. Risk Management for Aseptic Processing. Journal of Validation Technology. 2009; 15(2): 25-33.

  • Gad SC. Handbook of Pharmaceutical Biotechnology. Gad SC, editor: Wiley; 2007.

  • Keizer JA, Vos J-P, Halman JIM. Risks in new product development: devising a reference tool. R&D Management. 2005; 35(3):297-309.

  • Ranga S, Jaimini M, Sharma SK, Chauhan BS, Kumar A. A review on design of experiment. International Journal of Research and Reviews in Pharmacy and Applied science. 2013; 3(6): 867-82.

  • Monica RP, Rao P. Preparation and evaluation of immediate release tablets of meroclopramide HCL using Simplex Centruoid Mixture Design. International Journals of Pharma Tech Research. 2010; 2:1105.

  • Q8 Pharmaceutical Development – FDA guidance.

  • Kovalycsik M. Design Space and PAT - Q8 ICH Draft Guidance on Pharmaceutical Development. AVP, Wyeth Research Vaccines R&D, Quality Operations.

  • Khare R. Three Romeos And A Juliet An Early Brush With Design Of Experiments. www.isixsigma.com. Accessed 10 March 2016.

  • Burnham R. How to Select Design of Experiments Software. www.sixsigma.com. Accessed 10 March 2016.

  • Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical Quality by design. AAPS Journal. 2014; 16:771-83.

  • ICH Quality Implementation working group. Point to consider, ICH endorsed guide for ICH Q8/Q9/Q10 implementation. 2011

  • Altan S, Bergum J, Pfahler L, Senderak E, Sethuraman S, Vukovinsky KE. Statistical Considerations in Design Space Development Part I of III. Pharmaceutical Technology. 2010; 34(7): 66-70

  • Jadhav J, Girawale N, Chaudhari R, Quality by Design (QBD) Approach used in Development of Pharmaceuticals International Journals of Pure and Applied Bioscience. 2014; 2 (5): 21


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  • A Review on:Quality by Design (QbD)

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Authors

Vrushali R. Kadam
Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India
M. P. Patil
Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India
Vrushali V. Pawar
Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, India
Sanjay Kshirsagar
MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, India

Abstract


Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design and describe how it can be used to ensure pharmaceutical quality. Quality cannot be tested into products but quality should be built in by design. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product profile (TPP), Target product Quality profile (TPQP) and identify Critical quality attributed (CQA).On the basis of this we can design the product formulation and the process to meet the product attributes. These leads to recognize the impact of raw material Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT)

Keywords


Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT).

References