Abstract
Quality by Design (QbD) is a systematic approach for improvement that stresses product and process and begins with a predetermined objective, as recommended by the USFDA and International Council Harmonization (ICH). Regulatory bodies frequently highlight the use of ICH quality criteria, which include Q8, Q9, Q10, and Q11. The differentiation between the traditional and QbD helps to study the risk assessment and technique for developing new products. There are a few steps involved in pharmaceutical and Analytical QbD. Various factors were used for the study of QbD, such as Analytical Target Product Profile (ATPP), Risk Assessment Quality Design Space, Control Strategy, etc. Critical Quality Attribute (CQA) may be understood and analyzed via a way of means of understanding the goods and technique and risk evaluation is useful for effective verbal exchange among FDA and industry, research/improvement and production, and amongst a couple of production sites inside the company. Life-cycle management of analytical procedure begins off evolving with the establishment of ATP and maintains until the approach is in use. The design of the experiment (DoE) involves the Q8 guidelines. DoE has been used in the rational development and optimization of analytical methods. Culture media composition, mobile phase composition, flow rate, and time of incubation are input factors (independent variables) that may be screened and optimized using DoE. Process analytical technology is implemented for the understanding and identification of developing a product and techniques. There are various benefits and applications of QbD in the pharmaceutical industry.
Graphical Abstract
[1]
Peraman, R.; Bhadraya, K.; Padmanabha, R.Y. Analytical quality by design: A tool for regulatory flexibility and robust analytics. Int. J. Anal. Chem., 2015, 2015, 1-9.
[http://dx.doi.org/10.1155/2015/868727] [PMID: 25722723]
[http://dx.doi.org/10.1155/2015/868727] [PMID: 25722723]
[2]
Sachin, B. Analytical method development and validation by QbD approach–A review. Pharm. Sin., 2015, 6(8), 18-24.
[3]
Patil, AS; Pethe, AM (2013) Quality by design (QbD): A new concept for development of quality pharmaceuticals. Int. J. Pharm. Qual. Assur., 2013, 4(2), 13-19.
[4]
Nadpara, N.P.; Thumar, R.V.; Kalola, V.N.; Patel, P.B. Quality by design (QBD): A complete review. Int. J. Pharm. Sci. Rev. Res., 2012, 17(2), 20-28.
[5]
Purohit, PJ; Shah, KV Quality by design (qbd): New parameter for quality improvement & pharmaceutical drug development. Pharma. Sci. Monit., 2013, 3(3)
[6]
Cogdill, R.P.; Drennen, J.K. Risk-based quality by design (QbD): A Taguchi perspective on the assessment of product quality, and the quantitative linkage of drug product parameters and clinical performance. J. Pharm. Innov., 2008, 3(1), 23-29.
[http://dx.doi.org/10.1007/s12247-008-9025-3]
[http://dx.doi.org/10.1007/s12247-008-9025-3]
[7]
Mistree, RY; Chodhary, UM; Shah, CN; Upadhyay, U (2020) quality by design approach for pharmaceutical product development: A comprehensive review. J Pharm Sci Technol., 2020, 2(1)
[8]
Yu, L.X. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharm. Res., 2008, 25(4), 781-791.
[http://dx.doi.org/10.1007/s11095-007-9511-1] [PMID: 18185986]
[http://dx.doi.org/10.1007/s11095-007-9511-1] [PMID: 18185986]
[9]
Roy, S. Quality by design: A holistic concept of building quality in pharmaceuticals. Int. J. Pharm. Biomed. Res., 2012, 3(2), 100-108.
[12]
Beg, S.; Hasnain, Md.S.; Rahman, M. Introduction to quality by design (QbD): Fundamentals, Principles, and Applications. In: Pharmaceutical Quality by Design Principles and Applications; , 2019; pp. 1-17.
[http://dx.doi.org/10.1016/B978-0-12-815799-2.00001-0]
[http://dx.doi.org/10.1016/B978-0-12-815799-2.00001-0]
[13]
Callis, J.B.; Illman, D.L.; Kowalski, B.R. Process analytical chemistry. Anal. Chem., 1987, 59(9), 624A-637A.
[http://dx.doi.org/10.1021/ac00136a723]
[http://dx.doi.org/10.1021/ac00136a723]
[14]
Munson, J.; Freeman, S.C.; Gujral, B. A review of process analytical technology (PAT) in the US pharmaceutical industry. Curr. Pharm. Anal., 2006, 2(4), 405-414.
[http://dx.doi.org/10.2174/157341206778699582]
[http://dx.doi.org/10.2174/157341206778699582]
[15]
Weitzel, J; Forbes, RA; Snee, RD The use of the analytical target profile in the lifecycle of an analytical procedure: With an example for an HPLC procedure IVT. J. Valid. Technol., 2015.
[16]
Leuenberger, H.; Puchkov, M.; Krausbauer, E.; Betz, G. Manufacturing pharmaceutical granules: Is the granulation end-point a myth? Powder Technol., 2009, 189(2), 141-148.
[http://dx.doi.org/10.1016/j.powtec.2008.04.005]
[http://dx.doi.org/10.1016/j.powtec.2008.04.005]
[17]
Volta e Sousa, L.; Gonçalves, R.; Menezes, J.C.; Ramos, A. Analytical method lifecycle management in pharmaceutical industry: A review. AAPS PharmSciTech, 2021, 22(3), 128.
[http://dx.doi.org/10.1208/s12249-021-01960-9] [PMID: 33835304]
[http://dx.doi.org/10.1208/s12249-021-01960-9] [PMID: 33835304]
[18]
Nasr, M. Risk-based CMC review paradigm. In: In Advisory committee for pharmaceutical science meeting; , 2004.
[19]
US Department of Health and Human Services. Guidance for industry: Modified release solid oral dosage forms scale-up and post-approval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. Centre for drug Evaluation and Research; Food and Drug Administration: Rockville, MD, 1995.
[20]
Bhattacharya, J.; Pharm, M.; Phil, M. Quality risk management–Understanding and control the risk in pharmaceutical manufacturing industry. Int. J. Pharm. Sci. Invent., 2015, 4(1), 29-41.
[21]
Jain, S. Quality by design (QBD): A comprehensive understanding of implementation and challenges in pharmaceuticals development. Int. J. Pharm. Pharm. Sci., 2014, 6, 29-35.
[22]
Mollah, H.; Baseman, H.; Long, M. Risk management applications in pharmaceutical and biopharmaceutical manufacturing; Wiley, 2013.
[http://dx.doi.org/10.1002/9781118514399]
[http://dx.doi.org/10.1002/9781118514399]
[23]
US Food and Drug Administration. Guidance for Industry: Q9 quality risk management. US Department of Health and Human Service; FDA: Rockville, MD, 2006.
[24]
Fahmy, R.; Kona, R.; Dandu, R.; Xie, W.; Claycamp, G.; Hoag, S.W. Quality by design I: Application of failure mode effect analysis (FMEA) and Plackett-Burman design of experiments in the identification of “main factors” in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tablets. AAPS PharmSciTech, 2012, 13(4), 1243-1254.
[http://dx.doi.org/10.1208/s12249-012-9844-x] [PMID: 22993122]
[http://dx.doi.org/10.1208/s12249-012-9844-x] [PMID: 22993122]
[25]
Frank, T.; Brooks, S.; Creekmore, R.; Hasselbalch, B.; Murray, K.; Obeng, K.; Reich, S.; Sanchez, E. Quality risk management principles and industry case studies; Pharm Qual Res Inst Manuf Technol Comm, 2008, pp. 1-9.
[26]
Hakemeyer, C.; McKnight, N.; St John, R.; Meier, S.; Trexler-Schmidt, M.; Kelley, B.; Zettl, F.; Puskeiler, R.; Kleinjans, A.; Lim, F.; Wurth, C. Process characterization and design space definition. Biologicals, 2016, 44(5), 306-318.
[http://dx.doi.org/10.1016/j.biologicals.2016.06.004] [PMID: 27464992]
[http://dx.doi.org/10.1016/j.biologicals.2016.06.004] [PMID: 27464992]
[27]
Parr, M.K.; Schmidt, A.H. Life cycle management of analytical methods. J. Pharm. Biomed. Anal., 2018, 147, 506-517.
[http://dx.doi.org/10.1016/j.jpba.2017.06.020] [PMID: 28666555]
[http://dx.doi.org/10.1016/j.jpba.2017.06.020] [PMID: 28666555]
[28]
Bhutani, H.; Kurmi, M.; Singh, S.; Beg, S.; Singh, B. Quality by design (QbD) in analytical sciences: An overview. Qual. Assur., 2004, 3, 39-45.
[29]
Singh, R.; Muzzio, F.; Ierapetritou, M.; Ramachandran, R. A combined feed-forward/feed-back control system for a QbD-based continuous tablet manufacturing process. Processes., 2015, 3(2), 339-356.
[http://dx.doi.org/10.3390/pr3020339]
[http://dx.doi.org/10.3390/pr3020339]
[30]
Davis, KL; Kemper, MS; Lewis, IR Raman spectroscopy for monitoring real-time processes in the pharmaceutical industry. In: Pharmaceutical Applications of Raman Spectroscopy; Wiley, 2008.
[31]
Ohage, E.; Iverson, R.; Krummen, L.; Taticek, R.; Vega, M. QbD implementation and post approval lifecycle management (PALM). Biologicals, 2016, 44(5), 332-340.
[http://dx.doi.org/10.1016/j.biologicals.2016.06.007] [PMID: 27449920]
[http://dx.doi.org/10.1016/j.biologicals.2016.06.007] [PMID: 27449920]
[32]
Patwardhan, D.M.; Amrutkar, S.S.; Kotwal, T.S.; Wagh, M.P. Application of quality by design to different aspects of pharmaceutical technologies. Int. J. Pharm. Sci. Res., 2017, 8(9), 3649-3662.
[33]
Zhang, L; Mao, S Application of quality by design in the current drug development. Asian J Pharm Sci, 2017, 12(1), 1-8.
[http://dx.doi.org/10.1016/j.ajps.2016.07.006]
[http://dx.doi.org/10.1016/j.ajps.2016.07.006]
[34]
Rausand, M.; Hoyland, A. System reliability theory: models, statistical methods, and applications; John Wiley & Sons, 2003.
[35]
Tay, K.M.; Lim, C.P. On the use of fuzzy inference techniques in assessment models: part II: Industrial applications. Fuzzy Optim. Decis. Making, 2008, 7(3), 283-302.
[http://dx.doi.org/10.1007/s10700-008-9037-y]
[http://dx.doi.org/10.1007/s10700-008-9037-y]
[36]
Fukuda, I.M.; Pinto, C.F.F.; Moreira, C.S.; Saviano, A.M.; Lourenço, F.R. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Braz. J. Pharm. Sci., 2018, 54(spe), 54.
[http://dx.doi.org/10.1590/s2175-97902018000001006]
[http://dx.doi.org/10.1590/s2175-97902018000001006]
[37]
Gujral, G.; Kapoor, D.; Jaimini, M. An updated review on design of experiment (DOE) in pharmaceuticals. J. Drug Deliv. Ther., 2018, 8(3), 147-152.
[http://dx.doi.org/10.22270/jddt.v8i3.1713]
[http://dx.doi.org/10.22270/jddt.v8i3.1713]
[38]
Beg, S.; Swain, S.; Rahman, M.; Hasnain, M.S.; Imam, S.S. Application of design of experiments (DoE) in pharmaceutical product and process optimization.Pharmaceutical quality by design; Academic Press, 2019, pp. 43-64.
[http://dx.doi.org/10.1016/B978-0-12-815799-2.00003-4]
[http://dx.doi.org/10.1016/B978-0-12-815799-2.00003-4]
[39]
Verma, S.; Lan, Y.; Gokhale, R.; Burgess, D.J. Quality by design approach to understand the process of nanosuspension preparation. Int. J. Pharm., 2009, 377(1-2), 185-198.
[http://dx.doi.org/10.1016/j.ijpharm.2009.05.006] [PMID: 19446617]
[http://dx.doi.org/10.1016/j.ijpharm.2009.05.006] [PMID: 19446617]
[40]
Liliana, L. A new model of Ishikawa diagram for quality assessment. IOP Conference Series Materials Science and Engineering, 2016, p. 012099.
[http://dx.doi.org/10.1088/1757-899X/161/1/012099]
[http://dx.doi.org/10.1088/1757-899X/161/1/012099]
[41]
Patel, H.; Parmar, S.; Patel, B. A comprehensive review on quality by design (QbD) in pharmaceuticals. Int. J. Pharm. Sci. Rev. Res., 2013, 21(1), 223-236.
[42]
Rathore, A.S.; Winkle, H. Quality by design for biopharmaceuticals: Perspectives and challenges. Int. J. Pharm., 2009, 377(1-2), 28-36.
[http://dx.doi.org/10.1016/j.ijpharm.2009.05.038] [PMID: 19481687]
[http://dx.doi.org/10.1016/j.ijpharm.2009.05.038] [PMID: 19481687]
[43]
Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries; Ahuja, S.; Dong, M.W.; Kirsch, D.G., Eds.; John Wiley & Sons, 2010.
[44]
Rathore, A.S.; Branning, R.J. Risk assessment in the pharmaceutical industry. In: Quality by Design for Biopharmaceuticals: Principles and Case Studies; Rathore, A.S.; Branning, R.J., Eds.; John Wiley & Sons, 2009; pp. 155-184.
[http://dx.doi.org/10.1002/9780470466315]
[http://dx.doi.org/10.1002/9780470466315]
