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2000
Volume 22, Issue 4
  • ISSN: 1570-1638
  • E-ISSN: 1875-6220

Abstract

The document emphasizes the importance of addressing key issues in Quality Management Systems (QMS) to stay competitive and provide high-quality goods and services in a dynamic market. It highlights the need to adopt novel quality management techniques for long-term success. The fundamentals of Quality by Design (QbD) are discussed, tracing back to pioneers like Joseph M. Juran and the Six Sigma concept for effective implementation. QbD is described as a systematic approach focusing on risk management, Quality Target Product Profile (QTPP), and Critical Quality Attributes (CQAs) to create products meeting predetermined quality standards. QbD incorporates quality concepts into the development and production processes. Its goal is to guarantee the quality of the product by determining and managing important factors. Manufacturers can be flexible with it while still adhering to strict quality standards. It signifies a change in the industry's paradigm.

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2025-09-25

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References

  1. MishraV. ThakurS. PatilA. ShuklaA. Quality by design (QbD) approaches in current pharmaceutical set-up.Expert Opin. Drug Deliv.201815873775810.1080/17425247.2018.150476830044646
     [Google Scholar]
  2. PatilA.S. PetheA.M. (QbD): A new concept for development of quality pharmaceuticals.Int. J. Pharm. Qual.2013421319
     [Google Scholar]
  3. AdamE.E.Jr Alternative quality improvement practices and organization performance.J. Oper. Manage.1994121274410.1016/0272‑6963(94)90004‑3
     [Google Scholar]
  4. AhireS.L. LanderosR. GolharD. Total quality management: A literature review and an agenda for future research.Prod. Oper. Manag.19954327730610.1111/j.1937‑5956.1995.tb00057.x
     [Google Scholar]
  5. AksuB. YeğenG. Global Regulatory Perspectives on QbD in Pharma Manufacturing.Pharmaceutical QbD20191941
     [Google Scholar]
  6. AmrihP. DamayantiR.W. Pharma 4.0 Quality Management Challenge: A Literature Review. Proceedings of 12th Annual International Conference on Industrial Engineering and Operations Management (IEOM) Conference, 2022
     [Google Scholar]
  7. BoadenR.J. What is total quality management … and does it matter?Total Qual. Manage.19978415317110.1080/0954412979596
     [Google Scholar]
  8. BravoE. NapolitanoM. Quality management system for research biobanks: A tool to incentivize public-private partnerships.Advances in Biobanking Practice Through Public and Private Collaborations2017
     [Google Scholar]
  9. Milá CáceresL. ValdésR. GarciaC. TamayoA. Quality risk management, application review in pharmaceutical and biopharmaceutical industries.Bioprocessing201091263710.12665/J91.Valdes
     [Google Scholar]
  10. CasarettD. KarlawishJ.H.T. SugarmanJ. Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications.JAMA2000283172275228010.1001/jama.283.17.227510807388
     [Google Scholar]
  11. ChassinM.R. Assessing strategies for quality improvement.Health Aff. (Millwood)199716315116110.1377/hlthaff.16.3.1519141332
     [Google Scholar]
  12. DahlgaardJ.J. KanjiG.K. KristensenK. Fundamentals of total quality managementRoutledge200810.4324/9780203930021
     [Google Scholar]
  13. DjurisJ. DjuricZ. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.Int. J. Pharm.2017533234635610.1016/j.ijpharm.2017.05.07028579542
     [Google Scholar]
  14. FinklerC. KrummenL. Introduction to the application of QbD principles for the development of monoclonal antibodies.Biologicals201644528229010.1016/j.biologicals.2016.07.00427546184
     [Google Scholar]
  15. FlynnB.B. SchroederR.G. SakakibaraS. A framework for quality management research and an associated measurement instrument.J. Oper. Manage.199411433936610.1016/S0272‑6963(97)90004‑8
     [Google Scholar]
  16. GramppG. BosleyA. QadanM. SchielJ. SpasoffA. ValaxP. SchaeferG. Managing integrated continuous bioprocesses in real time: Deviations in product quality.Biotechnol. Prog.2023402341438013652
     [Google Scholar]
  17. HannonJ. HuangI.-C. LinC.-C. The mediating effects of organization commitment and job involvement on the relationship between quality of work life and customer service attitudes.1994
     [Google Scholar]
  18. HughesR.G. Tools and strategies for quality improvement and patient safety.Patient Safety and Quality: An Evidence-based Handbook for Nurses2008
     [Google Scholar]
  19. HulscherM.E.J.L. LaurantM.G. GrolR.P. Process evaluation on quality improvement interventions.Qual. Saf. Health Care2003121404610.1136/qhc.12.1.4012571344
     [Google Scholar]
  20. JainS. QbD (QBD): A comprehensive understanding of implementation and challenges in pharmaceuticals development.Int. J. Pharm. Pharm. Sci.201462935
     [Google Scholar]
  21. José TaríJ. Components of successful total quality management.TQM Mag.200517218219410.1108/09544780510583245
     [Google Scholar]
  22. KaplanH.C. ProvostL.P. FroehleC.M. MargolisB.A. The Model for Understanding Success in Quality (MUSIQ): Building a theory of context in healthcare quality improvement.BMJ Qual. Saf.2012211132021835762
     [Google Scholar]
  23. KaynakH. The relationship between total quality management practices and their effects on firm performance.J. Oper. Manage.200321440543510.1016/S0272‑6963(03)00004‑4
     [Google Scholar]
  24. KeshavarzM. KhademiS.H. MohamadipourJ. FarajollahiM. Plan for applying total quality management in education for torbat heydariyeh university of medical sciences.J Educ Psychol Stud201374480496[JEPS].10.53543/jeps.vol7iss4pp480‑496
     [Google Scholar]
  25. KrishnanR. ShaniA.B. GrantR.M. BaerR. In search of quality improvement: Problems of design and implementation.Acad. Manage. Perspect.19937472010.5465/ame.1993.9503103187
     [Google Scholar]
  26. KumarL. MehrotraS. Implementation of quality by design in the formulation and development of nanocarrier-based drug delivery systems.Crit Rev Ther Drug Carrier Syst.2023403146
     [Google Scholar]
  27. LakhalL. PasinF. LimamM. Quality management practices and their impact on performance.Int. J. Qual. Reliab. Manage.200623662564610.1108/02656710610672461
     [Google Scholar]
  28. LeeS.H. KimJ.K. JeeJ.P. JangD.J. ParkY.J. KimJ.E. Quality by Design (QbD) application for the pharmaceutical development process.J. Pharm. Investig.202252664968210.1007/s40005‑022‑00575‑x
     [Google Scholar]
  29. LynnJ. BailyM.A. BottrellM. JenningsB. LevineR.J. DavidoffF. CasarettD. CorriganJ. FoxE. WyniaM.K. AgichG.J. O’KaneM. SperoffT. SchyveP. BataldenP. TunisS. BerlingerN. CronenwettL. FitzmauriceJ.M. DublerN.N. JamesB. The ethics of using quality improvement methods in health care.Ann. Intern. Med.2007146966667310.7326/0003‑4819‑146‑9‑200705010‑0015517438310
     [Google Scholar]
  30. Organization of monitoring in the quality management system of the educational process when training of specialists.Humanities & Social Sciences Reviews20197622723210.18510/hssr.2019.7642
     [Google Scholar]
  31. Martin-MoeS. NastC. An overview of QbD for drug product.QbD for Biopharmaceutical Drug Product Development20154759
     [Google Scholar]
  32. Martínez-LorenteA.R. DewhurstF. DaleB.G. Total quality management: Origins and evolution of the term.TQM Mag.199810537838610.1108/09544789810231261
     [Google Scholar]
  33. Meeker-O’ConnellA. SamL.M. BergamoN. LittleJ.A. TransCelerate’s clinical quality management system: From a vision to a conceptual framework.Ther. Innov. Regul. Sci.201650439741310.1177/216847901665130030227025
     [Google Scholar]
  34. MittmanB.S. Creating the evidence base for quality improvement collaboratives.Ann. Intern. Med.20041401189790110.7326/0003‑4819‑140‑11‑200406010‑0001115172904
     [Google Scholar]
  35. MizunoS. Management for Quality Improvement: The 7 new QC Tools.CRC Press2020
     [Google Scholar]
  36. NadparaN.P. ThumarR.V. KalolaV.N. PatelP.B. QbD (QBD): A complete review.Int. J. Pharm. Sci. Rev. Res.20121722028
     [Google Scholar]
  37. NayakA.K. AhmedS.A. BegS. TabishM. HasnainM.S. Application of QbD for the development of biopharmaceuticals.Pharmaceutical QbD2019399411
     [Google Scholar]
  38. NémethZ. Application of the QbD methodology in the design and development process of liposomal delivery systemsHungarySzegedi Tudomanyegyetem2022
     [Google Scholar]
  39. PriedeJ. Implementation of quality management system ISO 9001 in the world and its strategic necessity.Procedia Soc. Behav. Sci.2012581466147510.1016/j.sbspro.2012.09.1133
     [Google Scholar]
  40. RajoraA. ChhabraG. QbD approach: regulatory need, current, and future perspective.Asian Journal of Pharmaceutical Sciences and Clinical Research2021146
     [Google Scholar]
  41. RileyW.J. MoranJ.W. CorsoL.C. BeitschL.M. BialekR. CofskyA. Defining quality improvement in public health.J. Public Health Manag. Pract.20101615710.1097/PHH.0b013e3181bedb4920009636
     [Google Scholar]
  42. SafiullinL.N. IsmagilovaG.N. SafiullinN.Z. Development of the theory of demand and utility in the conditions of change of quality of the goods. 3rd International Conference on Qualitative and Quantitative Economics Research (QQE) Proceedings, 2013;pp. 3742
     [Google Scholar]
  43. SangshettiJ.N. DeshpandeM. ZaheerZ. ShindeD.B. AroteR. Quality by design approach: Regulatory need.Arab. J. Chem.201710S3412S342510.1016/j.arabjc.2014.01.025
     [Google Scholar]
  44. SchoutenL.M.T. HulscherM.E.J.L. EverdingenJ.J.E. HuijsmanR. GrolR.P.T.M. Evidence for the impact of quality improvement collaboratives: systematic review.BMJ200833676591491149410.1136/bmj.39570.749884.BE18577559
     [Google Scholar]
  45. ShirohiwalaR. ShahC. UpadhyayU. Implementation of Qbd & AQbD approach in pharmaceutical formulation and analytical method development: A Comprehensive Research-Review.2023
     [Google Scholar]
  46. ShortellS.M. O’BrienJ.L. CarmanJ.M. FosterR.W. HughesE.F. BoerstlerH. O’ConnorE.J. Assessing the impact of continuous quality improvement/total quality management: concept versus implementation.Health Serv. Res.19953023774017782222
     [Google Scholar]
  47. SreelekhaS. KumarK.V. MahammedN. ReshmaT. SreeG.U. BashaS.S. BhuvaneswariM. Quality by design approaches in pharmaceutical development and solid dosage forms production: A narrative overview.Jordan J. Pharm. Sci.202316477078410.35516/jjps.v16i4.908
     [Google Scholar]
  48. TekadeR.K. The future of pharmaceutical product development and research.Academic Press2020
     [Google Scholar]
  49. ter HorstJ.P. TurimellaS.L. MetsersF. ZwiersA. Implementation of quality by design (QbD) principles in regulatory dossiers of medicinal products in the european union (EU) between 2014 and 2019.Ther. Innov. Regul. Sci.202155358359010.1007/s43441‑020‑00254‑933439461
     [Google Scholar]
  50. TribusM. Quality Management in EducationERIC Clearinghouse1992
     [Google Scholar]
  51. UppalA. KoduriC.K. YadlapalliS. ChirmuleN. ChakrabartiR. AtoufF. Recommendations for enhancing quality and capability of Indian biopharmaceutical industry: Summary of a workshop.J. Pharm. Sci.2020109102958296110.1016/j.xphs.2020.07.01432710904
     [Google Scholar]
  52. VishwasraoS.S. SinghS. Current perspective on opportunities and adoption challenges of QbD implementation in pharmaceutical product development.Pharmaceutical Process Development2016333441
     [Google Scholar]
  53. ViswanathanC. RamdasiS. KulkarniR. BopardikarA. Quality management in the manufacture of stem-cell-based-products.J. Stem Cells2017124
     [Google Scholar]
  54. WalsheK. Understanding what works-and why-in quality improvement: the need for theory-driven evaluation.Int. J. Qual. Health Care2007192575910.1093/intqhc/mzm00417337518
     [Google Scholar]
  55. WeinerB.J. AlexanderJ.A. ShortellS.M. BakerL.C. BeckerM. GeppertJ.J. Quality improvement implementation and hospital performance on quality indicators.Health Serv. Res.200641230733410.1111/j.1475‑6773.2005.00483.x16584451
     [Google Scholar]
  56. WoodhouseD. Quality and Quality Assurance.Quality and Internationalisation in Higher Education1999.
     [Google Scholar]
  57. AggelogiannopoulosD. DrosinosE.H. AthanasopoulosP. Implementation of a quality management system (QMS) according to the ISO 9000 family in a Greek small-sized winery: A case study.Food Control20071891077108510.1016/j.foodcont.2006.07.010
     [Google Scholar]
  58. BacoupP. MichelC. HabchiG. PralusM. From a quality management system (QMS) to a lean quality management system (LQMS).TQM J.2018301204210.1108/TQM‑06‑2016‑0053
     [Google Scholar]
  59. GyaniG.J. Effectiveness of QMS certification process.Total Qual. Manage. Bus. Excell.200819326327910.1080/14783360701601843
     [Google Scholar]
  60. TaríJ.J. Molina-AzorínJ.F. HerasI. Benefits of the ISO 9001 and ISO 14001 standards: A literature review.J. Ind. Eng. Manag.201252297322[JIEM].10.3926/jiem.488
     [Google Scholar]
  61. International standard. Software Engineering Software product Quality Requirements and Evaluation (SQUARE).2005
     [Google Scholar]
  62. WHO guideline on the implementation of quality management systems for national regulatory authorities.WHO Drug Inf.2019333410457
     [Google Scholar]
  63. SuprinM. ChowA. PillweinM. RoweJ. RyanM. Rygiel-ZbikowskaB. WilsonK.J. TomlinI. Quality risk management framework: guidance for successful implementation of risk management in clinical development.Ther. Innov. Regul. Sci.2019531364410.1177/216847901881775230789098
     [Google Scholar]
  64. BrooksT. GunningJ.G. SpillaneJ.P. ColeJ. Regulatory decoupling and the effectiveness of the ISO 9001 quality management system in the construction sector in the UK – a case study analysis.Construct. Manag. Econ.20213912988100510.1080/01446193.2021.1983186
     [Google Scholar]
  65. World Health Organization. Implementing quality management systems in national regulatory authorities: Examples and practices.2021
     [Google Scholar]
  66. GardaziS.U. ShahidA.A. Taking compliance patterns and quality management system (QMS) framework approach to ensure medical billing compliance.Health Information Science Second International Conference, HIS 2013London, UKMarch 25-272013
     [Google Scholar]
  67. NatarajanD. ISO 9001 Quality Management Systems.Springer201710.1007/978‑3‑319‑54383‑3
     [Google Scholar]
  68. Ab WahidR. GriggN.P. QMS external quality auditors’ education framework: findings from an iterative Delphi study.TQM J.20223451320134010.1108/TQM‑03‑2021‑0091
     [Google Scholar]
  69. PurohitP. ShahK. QbD (QBD): new parameter for quality improvement & pharmaceutical drug development.Pharma Sci. Monitor201333
     [Google Scholar]
  70. PowarP.V. ShirodeD. Quality by design: Predefined objected quality and quality risk management.Int. J. Pharm. Sci. Rev. Res.2020651142610.47583/ijpsrr.2020.v65i01.002
     [Google Scholar]
  71. OrlandiniS. PinzautiS. FurlanettoS. Application of quality by design to the development of analytical separation methods.Anal. Bioanal. Chem.20134052-344345010.1007/s00216‑012‑6302‑222941176
     [Google Scholar]
  72. ChoudharyV. Design and conduct of clinical studies by integration of QbD (QbD) into quality management system (QMS)-a pragmatic approach.Clin Res Open Access202172
     [Google Scholar]
  73. NarwadeN. JadhavJ.B. PatilR.D. Implementation of QBD to analytical method development processes.World J. Pharm. Res.20144115201535
     [Google Scholar]
  74. TombaE. FaccoP. BezzoF. BaroloM. Latent variable modeling to assist the implementation of Quality-by-Design paradigms in pharmaceutical development and manufacturing: A review.Int. J. Pharm.2013457128329710.1016/j.ijpharm.2013.08.07424016743
     [Google Scholar]
  75. BegS. RahmanM. KohliK. Quality-by-design approach as a systematic tool for the development of nanopharmaceutical products.Drug Discov. Today201924371772510.1016/j.drudis.2018.12.00230557651
     [Google Scholar]
  76. SherstobitovaA. IskoskovM. The role of quality management systems for educational institutions in the digital economy. IOP Conf. Ser.: Mater. Sci. Eng.202098601202310.1088/1757‑899X/986/1/012023
     [Google Scholar]
  77. EisnerR. PatelR. Strengthening the regulatory system through the implementation and use of a quality management system.Pan American Journal of Public Health2017
     [Google Scholar]
  78. MizanbekovaS. The quality management system improvement for the enhancement of production competitiveness.Revista Espacios20173842
     [Google Scholar]
  79. Bogusz-CzerniewiczM. Quality management system in radiotherapy in the light of regulations applicable in Poland.Contemp Oncol (Pozn).201216214014610.5114/wo.2012.28793
     [Google Scholar]
  80. AksuB. MesutB. QbD (QbD) for pharmaceutical area.Journal of Faculty of Pharmacy of Istanbul University2015452233251
     [Google Scholar]
  81. BegS. Introduction to QbD (QbD): fundamentals, principles, and applications.Pharmaceutical QbD.Elsevier2019117
     [Google Scholar]
  82. AhireK.M. SureshR.A. AdeA.V. A review on QBD approach (QBD) for pharmaceuticals.
     [Google Scholar]
  83. JovanovskaV.P. Development and formulation optimisation of modified release dosage form using QbD–QbD aproach.2018
     [Google Scholar]
  84. ZagaloD.M. SousaJ. SimõesS. Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation.Eur. J. Pharm. Biopharm.202217812410.1016/j.ejpb.2022.07.01435908664
     [Google Scholar]
  85. MalikA. GochhayatG. AlamM.S. KumarM. PalP. SinghR. SainiV. Quality by Design: A new practice for production of pharmaceutical products.J. Drug Deliv. Ther.201991-s41642410.22270/jddt.v9i1‑s.2370
     [Google Scholar]
  86. SwarbrickB. QbD in practice.Multivariate Analysis in the Pharmaceutical Industry.Elsevier2018125171
     [Google Scholar]
  87. SusmithaA. RajithaG. EriG.K. A comprehensive review on QbD driven analytical procedures developed for the analysis of various drugs.J. Liq. Chromatogr. Relat. Technol.2023461-5123610.1080/10826076.2023.2204238
     [Google Scholar]
  88. Castillo-HenríquezL. Murillo-CastilloB. Chaves-SilesL. Mora-RománJ.J. Ramírez-ArguedasN. Hernández-MoraÉ. Vega-BaudritJ. QbD: a suitable methodology in industrial pharmacy for Costa Rican universities.Sci. Pharm.20229023410.3390/scipharm90020034
     [Google Scholar]
  89. JaiswalR. MeharP. AwachatP. BhanareP. Role of QMS in Regulatory Compliance.2023
     [Google Scholar]
  90. BhagatR. BojarskiL. ChevalierS. GörtzD.R. Le MeignenS. MakowskiM. NadolnyP. PillweinM. SuprinM. TurriS. Quality tolerance limits: framework for successful implementation in clinical development.Ther. Innov. Regul. Sci.202155225126110.1007/s43441‑020‑00209‑032885397
     [Google Scholar]
  91. RathoreA.S. KapoorG. Implementation of quality by design toward processing of food products.Prep. Biochem. Biotechnol.201747543544010.1080/10826068.2017.131560128402220
     [Google Scholar]
  92. NasrM.M. KrummeM. MatsudaY. TroutB.L. BadmanC. MasciaS. CooneyC.L. JensenK.D. FlorenceA. JohnstonC. KonstantinovK. LeeS.L. Regulatory perspectives on continuous pharmaceutical manufacturing: moving from theory to practice: September 26-27, 2016, international symposium on the continuous manufacturing of pharmaceuticals.J. Pharm. Sci.2017106113199320610.1016/j.xphs.2017.06.01528655487
     [Google Scholar]
  93. MisraA. MehtaD. Derivation of design space for blend homogeneity for robust tablet manufacturing by an integrated QBD approach.Neuroquantology20222096640
     [Google Scholar]
  94. BhatiaH. ReadE. AgarabiC. BrorsonK. LuteS. YoonS. A design space exploration for control of Critical Quality Attributes of mAb.Int. J. Pharm.2016512124225210.1016/j.ijpharm.2016.08.04627575657
     [Google Scholar]
  95. SprengerK. NickersonD. Meeker-O’ConnellA. MorrisonB.W. QbD in clinical trials: A collaborative pilot with FDA.Ther. Innov. Regul. Sci.201347216116610.1177/009286151245890930227529
     [Google Scholar]
  96. BhandariS.B.B. BaldiA. Total quality management of pharmaceuticals.Recent approaches and advancements total quality management of pharmaceuticals20144II655660
     [Google Scholar]
  97. ShaughnessyE.E. ShahA. AmbroggioL. StatileA. Quality improvement feature series article 1: Introduction to quality improvement.J. Pediatric Infect. Dis. Soc.20187161010.1093/jpids/pix06128992204
     [Google Scholar]
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Bridging the Gap: Quality by Design as a Catalyst for Enhanced Quality Management Systems in Biopharmaceutical Manufacturing
Current Drug Discovery Technologies 22, E15701638312326 (2025); https://doi.org/10.2174/0115701638312326240918093333
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  • Article Type:     Review Article
Keyword(s): biopharmaceuticals; FDA and EMA guidelines; quality by design (QbD); Quality management system (QMS); regulatory framework; six sigma

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