Quality by Design (QBD) Tool for Quality Control in Pharmaceutical Industry
DOI:
https://doi.org/10.37285/ijpsn.2023.16.2.10Abstract
Multiple approaches are operating in the modern world to analyze pharmaceutical dosage forms, but Quality by design is one of the most prominent approaches that can be used. Quality must be built into the product or method during pharmaceutical or analytical development, per the Quality by Design (QbD) concept. Commonly, input factors affect the Quality of products and techniques. The system is highly dynamic and adaptable to the changing environment, with better efficiency and an enhanced level of manufacturing within it. The quality-by-design strategy is also more consistent in upholding the product's designs and quality characteristics. The paper aims to better organize information by understanding and studying the elements of Quality by design. The pharmaceutical sector places a strong emphasis on quality prospects while also improving productivity and product designs. The paper seeks to describe the design development and study its multiple factors.
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Keywords:
Quality by Design (QbD), Quality target product profile, elements of QbD, Risk assessments, Control strategy
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References
Fukuda I.M, Pinto C.F.F, Moreira C.D.S, Saviano A.M. and Lourenco F.R. Design of experiments (DoE) applied to pharmaceutical and analytical Quality by design (QbD). Braz. J. Pharm. Sci. (2018). 54.
Han J.K, Shin B.S., and Choi D.H. Using multivariate analysis and the quality-by-design approach, a comprehensive study of intermediate and critical quality attributes for process control of high-shear wet granulation. Pharmaceutics (2019). 11(6):252.
Cunha S, Costa C.P, Loureiro J.A, Alves J, Peixoto A.F, Forbes B, Sousa Lobo J M and Silva A C. Double optimization of rivastigmine-loaded nanostructured lipid carriers (NLC) for nose-to-brain delivery using the Quality by design (QbD) approach: Formulation variables and instrumental parameters. Pharmaceutics (2020). 12(7): 599.
Simões A, Veiga F, Figueiras A and Vitorino C (2018). A practical framework for implementing Quality by Design to develop topical drug products: Nano system-based dosage forms. Int. J. Pharm (2018). 548(1): 385-399.
Bartos C, Pallagi E, Szabo-Revesz P, Ambrus R, Katona G, Kiss T, Rahim M and Csoka I. Formulation of levodopa containing dry powder for nasal delivery applying the quality-by-design approach. Eur. J. Pharm. Sci (2018). 123: 475-483.
Joshi A, Rajput A, Verma P, Srivastava S.P, Sharma U, and Mishra S. Quality by design–a tool for the pharmaceutical industry that has no near end. Int. J. Pharm. Res. (2021). 13(3).
Katona G, Balogh G.T, Dargo G, Gaspar R, Marki A, Ducza E, Ivanov A S, Tomosi F, Kecskemeti G, Janaky T, Kiss T, Ambrus R, Pallagi E, Revesz P S and Csoka I. Development of meloxicam-human serum albumin nanoparticles for nose-to-brain delivery via application of a quality-by-design approach. Pharmaceutics (2020). 12(2):97.
Lionberger R A, Lee S L, Lee L, Raw A, and Yu L X. Quality by Design: Concepts for ANDAs. The AAPS Journal (2008). 10(2): 268–276.
Q9: Quality Risk Management. ICH Harmonized Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.
Q8 (R1): Pharmaceutical Development, Revision 1, ICH Harmonized Tripartite Guidelines, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2007.
Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2007.
Colombo S, Beck-Broichsitter M, Botker J. P, Malmsten M, Rantanen J. and Bohr A. Transforming nanomedicine manufacturing toward Quality by Design and microfluidics. Adv. Drug Deliv. Rev (2018). 128:115-131.
Csoka I, Pallagi E and Paal T.L. Extension of quality-by-design concept to the early development phase of pharmaceutical R&D processes. Drug Discov. Today (2018). 23(7): 1340-1343.
Beg S, Rahman M and Swain S. Quality by design applications in pharmaceutical product development. Pharma Focus Asia (2020). 38:1-5.
Display A, Avohou H.T, Lebrun P, Hubert P and Hubert C. Quality by Design approach for analyzing pharmaceutical products and substances impurities. TrAC Trends in Analytical Chemistry (2018). 101:24-33.
Leng D, Thanki K, Fattal E, Foged C, an d Yang M. Engineering of budesonide-loaded lipid-polymer hybrid nanoparticles using a quality-by-design approach. Int. J. Pharm. Res (2018). 548(2):740-746.
Pallagi E, Ismail R, Paal T.L. and Csoka I. Initial risk assessment as part of the Quality by design in peptide drug-containing formulation development. Eur. J. Pharm (2018). 122:160-169.
Nakach M, Authelin J.R, Corsini C and Gianola G. Jet milling industrialization of sticky active pharmaceutical ingredients using the quality-by-design approach. Pharm Dev Technol (2019). 24(7):849-863.
Buttini F, Rozou S, Rossi A, Zoumpliou V, and Rekkas D.M. The application of Quality by design framework in the pharmaceutical development of dry powder inhalers. Eur. J. Pharm. Sci (2018). 113:64-76.
Su Q, Yasasvi B, Shah Y, Ganesh S, Moreno M, Liu J, Gonzalez M, Nima Y, O'Connor T, Reklaitis G, Nagy Z. Data reconciliation in the Quality-by-Design (QbD) implementation of pharmaceutical continuous tablet manufacturing. Int. J. Pharm (2019). 563: 259-272.
USFDA Office of Generic Drugs. Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms (2012). Available at https://www.pharmaexcipients.com/quality-by-design-for-andas-an-example-for-immediate-release-dosage-forms/ (accessed 26/2/2022).
