Patil Divyashree Kantilal,
Mahale Devendra S,
Amit Kumar R Dhankani,
Mansi A Dhankani,
Sunil P. Pawar,
- Student M Pharm Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Student M Pharm Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutics, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Principal P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
Abstract
The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development and manufacturing, thereby enhancing product quality, safety, and efficacy while mitigating risks. Central to the Quality by Design framework is the concept of critical quality attributes, which are vital characteristics of a drug product that ensure its desired performance and therapeutic effectiveness. Through a thorough understanding of critical quality attributes, pharmaceutical companies can design robust control strategies and implement riskbased approaches to ensure consistent product quality throughout the product lifecycle. Moreover, the adoption of Quality by Design principles necessitates a paradigm shift in regulatory expectations, with agencies such as the International Conference on Harmonization and the United States Food and Drug Administration advocating for a more science-based and integrated approach to quality management. The use of cutting-edge techniques and technologies, such as Process Analytical Technology and Design of Experiments, is essential to the effective application of Quality by Design. Pharmaceutical producers may now methodically identify and adjust key process parameters, improving process robustness, process comprehension, and product quality control; thanks to these cutting-edge methodologies. Furthermore, the present review underscored the importance of integrating Quality by Design principles into the broader product development lifecycle, from early-stage formulation development to commercial manufacturing. By embedding Quality by Design principles into every stage of the development process, pharmaceutical companies can streamline operations, accelerate time-tomarket, and ultimately deliver safer and more effective medicines to patients worldwide. Overall, the present review offered valuable insights into the transformative role of Quality by Design in shaping the future of pharmaceutical quality assurance and regulatory compliance.
Keywords: Pharmaceutical industry, Quality by Design (QbD), Critical quality attributes (CQAs), Regulatory landscape, Risk assessment.
[This article belongs to Research & Reviews: A Journal of Pharmaceutical Science(rrjops)]
References
1. Beg S, Hasnain MS, Rahman M, Swain S. Introduction to quality by design (QbD): fundamentals, principles, and applications. In: Pharmaceutical Quality by Design. New Delhi: Academic Press; 2019. 1–17p.
2. Nadpara NP, Thumar RV, Kalola VN, Patel PB. Quality by design (QBD): A complete review. Int J Pharm Sci Rev Res. 2012; 17(2): 20–28p.
3. Calhan SD, Eker ED, Sahin NO. Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry. European Journal of Chemistry. 2017; 8(4): 430–433p.
4. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Understanding pharmaceutical quality by design. The AAPS Journal. 2014; 16: 771–783p. doi: 10.1208/s12248–014-9598-3.
5. Ter Horst JP, Turimella SL, Metsers F, Zwiers A. Implementation of Quality by Design (QbD) principles in regulatory dossiers of medicinal products in the European Union (EU) between 2014 and 2019. Therapeutic Innovation & Regulatory Science. 2021; 55: 583–590p. Available from: https://doi.org/10.1007/s43441-020-00254-9
6. Anastasia G. Lolas, Anurag S. Rathore. (2013). Regulatory Challenges in the QbD Paradigm. Bioprocess Development Forum. [online] Biopharm International Magazine. Available from: https: //www.processdevelopmentforum.com/articles/regulatory-challenges-in-the-qbd-paradigm/3/
7. Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of Chemistry. 2017; 10: S3412–S3425. Available from: https://doi.org/10.1016/j.arabjc.2014.01.025
8. Aru PB, Gulhane MS, Katekar VA, Deshmukh SP. Quality by Design (QbD) in pharmaceutical development: A comprehensive review. GSC Biological and Pharmaceutical Sciences. 2024; 26(1): 328–340p.
9. Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J. Pharmaceutical product development: A quality by design approach. International Journal of Pharmaceutical Investigation. 2016; 6(3): 129p.
10. Darkunde SL. A review on quality by design. International Journal of Pharmaceutical Chemistry and Analysis. 2020; 5(1): 1–6p. DOI: 10.18231/2394–2797.2018.0001
11. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Understanding pharmaceutical quality by design. AAPS J. 2014; 16(4): 771–783p. doi: 10.1208/s12248-014- 9598-3.
12. Fukuda IM, Pinto CF, Moreira CD, Saviano AM, Lourenço FR. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Brazilian Journal of Pharmaceutical Sciences. 2018; 54: e1006.
13. Ranga S, Jaimini M, Sharma SK, Chauhan BS, Kumar A. A review on Design of Experiments (DOE). Int J Pharm Chem Sci. 2014; 3(1): 216–224p.
14. Riley BS, Li X. Quality by Design and Process Analytical Technology for Sterile Products—Where Are We Now? AAPS PharmSciTech. 2011; 12: 114–118p. Available from: https://doi.org/10.1208/s12249–010-9566-x
Research & Reviews: A Journal of Pharmaceutical Science
Volume | 15 |
Issue | 02 |
Received | April 8, 2024 |
Accepted | May 23, 2024 |
Published | June 26, 2024 |