Author(s):
Kunal S. Salunkhe, Sanket K. Maske, Amol R. Pawar, Vikas V. Patil, Pankaj S. Patil
Email(s):
Email ID Not Available
DOI:
10.52711/0974-4150.2025.00063 
Address:
Kunal S. Salunkhe1* Sanket K. Maske1, Amol R. Pawar1,2*, Vikas V. Patil1, Pankaj S. Patil1
1Department of Quality Assurance, Kisan Vidya Prasarak Sanstha’s, Institute of Pharmaceutical Education, Boradi 425428.
2Research scholar, Sankalchand Patel University, Visnagar -384315 (Gujarat-India).
*Corresponding Author
Published In:
Volume - 18,
Issue - 6,
Year - 2025
ABSTRACT:
In terms of enhancing "the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance," Process Analytical Technology (PAT) assures to bring about a larger, brighter future’’. All regulatory authorities focus a high priority on Quality of pharmaceutical Product The pharmaceutical industry may see a significant shift in their market share if these quality standards are not met. The pharmaceutical sector is supremely regulated industry since it is overseen by several regulatory organizations. Process analytical technology (PAT) is a method to plan, assess and regulate pharmaceutical production methods by examining essential process parameters influencing the critical quality features.
Cite this article:
Kunal S. Salunkhe, Sanket K. Maske, Amol R. Pawar, Vikas V. Patil, Pankaj S. Patil. Role of Process Analytical Technology in Enhancing Quality Assurance. Asian Journal of Research in Chemistry. 2025; 18(6):420-6. doi: 10.52711/0974-4150.2025.00063
Cite(Electronic):
Kunal S. Salunkhe, Sanket K. Maske, Amol R. Pawar, Vikas V. Patil, Pankaj S. Patil. Role of Process Analytical Technology in Enhancing Quality Assurance. Asian Journal of Research in Chemistry. 2025; 18(6):420-6. doi: 10.52711/0974-4150.2025.00063 Available on: https://ajrconline.org/AbstractView.aspx?PID=2025-18-6-8
REFERENCES:
1. FDA, Guidance For Industry: PAT – a framework for innovative pharmaceutical development, manufacturing and quality assurance. September 2004.
2. Arti Swami, Shivani Chakankar, Prajakta Chavan. A critical review on recently used pat in pharmaceutical industry. RJPT
3. Rakshit V Thumar, Vidhi N Kalola, Nishendu P Nadpara, Parula B Patel. A complete review of process analytical technology. Int J Pharm Sci Rev Res. 2012; 17; 57-65.
4. Bakeev KA. Near-infrared spectroscopy as a process analytical tool. Part ii. Atline and on-line applications and implementation strategies. Spectroscopy 2004
5. Anurag S. Rathod, Naveen Gjesubalan. Perspectives on process analytical technology. Bio Pharm International. May 2022; 35(5): 31–35
6. Akash S. Mali, Monali Jagtap, P Karekar, A Maruška. A brief review on process analytical technology (PAT). International Journal of Current Pharmaceutical Res. 8(1): 10-15
7. Minnich, C. B.; Buskens, P.; Steffens, H. C.; B¨Auerlein, P. S.; Butvina, L. N.; Ku¨Pper, L.; Leitner, W.; Liauw, M. A.; Greiner, L. Org. Process Res. Dev. 2007; 11(1): 94–97.
8. Aarti Shastri, Kajal Dhumal, Aishwarya Patil, Dipali Sawant, Swarupa Hatolkar. Process analytical technology (PAT): Enhancing quality and efficiency in pharmaceutical development and production. Journal For Reattach Therapy and Developmental Diversities. 6(1): 1963-1973.
9. Katherine A. Bakeev, Jun Chen, Gregory J. Process analytical technology (PAT): Use from development through implementation in the pharmaceutical industry.
10. Poonam Ingalwad, Vikram Veer, Ashok Bhosale and Nayna Khedekar. Illustrative review on process analytical technology. World Journal of Pharmaceutical Research. 6: 760-769.
11. Selda Dogan Calhan, Ebru Derici Eker and Nefise Ozlen Sahin. Quality by design (QBD) and process analytical technology (PAT) applications in pharmaceutical industry. European Journal of Chemistry. 2017; 8(4): 430‐433
12. Mike, F.; Bozdag, P. S.; Oner, L. Hacettepe. Univ. J. Fac. Pharm. 2013; 33(2): 203‐230.
13. Zhang, L.; Mao, S. Asian J. Pharm. Sci. 2017; 12(1): 1‐8.
14. Poonam Ingalwad, Vikram Veer, Ashok Bhosale. Illustrative review on process analytical technology. World Journal of Pharmaceutical Research. 9(6): 760-769.
15. Jaydeep Ganguly, Gerrit Vogel. 'Process Analytical Technology. J Int Soc Pharm Eng. 2006; 26: 1-9.
16. Goodwin, D.J.; Van Den Ban, S.; Denham, M.; Barylski, I. Real time release testing of tablet content and content uniformity. Int. J. Pharm. 2018; 537: 183–192.
17. Dasu, M.; Naresh, J.R. Real time release testing-a new quality paradigm for pharmaceutical development. Int. J. Pharm. Sci. Rev. Res. 2013; 19: 80–84.
18. Devi, N.G.; Chandramouli, R. Real time release testing-a review. J. Pharm. Res. 2018; 16: 314–318.
19. Panzitta, M.; Calamassi, N.; Sabatini, C.; Grassi, M.; Spagnoli, C.; Vizzini, V.; Ricchiuto, E.; Venturini, A.; Brogi, A.; Font, J.B. Spectrophotometry and pharmaceutical PAT/RTRT: Practical challenges and regulatory landscape from development to product lifecycle. Int. J. Pharm. 2021; 601: 120551.
20. Puchert, T.; Holzhauer, C.-V.; Menezes, J.; Lochmann, D.; Reich, G. A new PAT/QBD approach for the determination of blend homogeneity: combination of on-line nirs analysis with pc scores distance analysis (PC-SDA). Eur. J. Pharm. Biopharm. 2011; 78: 173–182.
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. Araújo, A.S.; Andrade, D.F.; Babos, D.V.; Pricylla, J.; Castro, J.A.G.; Sperança, M.A.; Gamela, R.R.; Machado, R.C.; Costa, V.C.; Guedes, W.N. Key information related to quality by design (qbd) applications in analytical methods development. Braz. J. Anal. Chem. 2021; 8: 14–28.
23. Patil, A.S.; Pethe, A.M. Quality by design (QBD): a new concept for development of quality pharmaceuticals. Int. J. Pharm. Qual. Assur. 2013; 4: 13–19.
24. US Food and Drug Administration. Guidance for industry, pat-a framework for innovative pharmaceutical development, manufacturing and quality assurance. 2004. Available online: http://www.fda.gov/cder/guidance/published.html (accessed on 10 march 2021).
25. Engelsen, S.B.; Mikkelsen, E.; Munck, L. New approaches to rapid spectroscopic evaluation of properties in pectic polymers. In the colloid science of lipids; Springer: Berlin, Germany, 1998; pp. 166–174.
26. Rinnan, A.; Van Den Berg, F.; Engelsen, S.B. Review of the most common pre-processing techniques for near-infrared spectra. Trends Analytical Chem. 2009; 28: 1201–1222.
27. Reimers, T.; Thies, J.; Stöckel, P.; Dietrich, S.; Pein-Hackelbusch, M.; Quodbach, J. Implementation of real-time and in-line feedback control for a fluid bed granulation process. Int. J. Pharm. 2019; 567: 118452.
28. Panchuk, V.; Yaroshenko, I.; Legin, A.; Semenov, V.; Kirsanov, D. Application of Chemometric methods to XRF-Data–a Tutorial review. Anal. Chim. Acta. 2018; 1040: 19–32.
29. Blanco, M.; Villarroya, I. NIR Spectroscopy: a rapid-response analytical tool. Trends Analytical Chem. 2002; 21: 240–250.
30. Cozzolino, D.; Cynkar, W.; Shah, N.; Smith, P. Multivariate data analysis applied to spectroscopy: potential application to juice and fruit quality. Food Res. Int. 2011; 44: 1888–1896.
31. Cronin, M.T.; Schultz, T.W. Pitfalls in QSAR. J. Mol. Struct. Theochem. 2003; 622: 39–51.
32. Kim, J.Y.; Chun, M.H.; Choi, D.H. Control strategy for process development of high-shear wet granulation and roller compaction to prepare a combination drug using integrated quality by design. Pharmaceutics. 2021; 13: 80.
33. Pauli, V.; Roggo, Y.; Pellegatti, L.; Trung, N.Q.N.; Elbaz, F.; Ensslin, S.; Kleinebudde, P.; Krumme, M. Process analytical technology for continuous manufacturing tableting processing: a case study. J. Pharm. Biomed. An. 2019; 162: 101–111.
34. Jiang, M.; Severson, K.A.; Love, J.C.; Madden, H.; Swann, P.; Zang, L.; Braatz, R.D. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing. Biotechnology. 2017; 114: 2445–2456.
35. Zeng, S.; Wang, L.; Chen, T.; Wang, Y.; Mo, H.; Qu, H. Direct analysis in real time mass spectrometry and multivariate data analysis: a novel approach to rapid identification of analytical markers for quality control of traditional Chinese medicine preparation. Anal. Chim. Acta. 2012; 733: 38–47.
36. De beer, T.; Allesø, M.; Goethals, F.; Coppens, A.; Vander Heyden, Y.; Lopez de Diego, H.; Rantanen, J.; Verpoort, F.; Vervaet, C.; Remon, J.P. Implementation of a process analytical technology system in a freeze-drying process using raman spectroscopy for in-line process monitoring. Anal. Chem. 2007; 79: 7992–8003.
37. Eun Ji Kim, Ji Hyeon Kim, Min-Soo Kim. Process analytical technology tools for monitoring pharmaceutical unit operations: a control strategy for continuous process verification, MDPI Journals, Basel, Switzerland.
38. Reddy, J.P.; Jones, J.W.; Wray, P.S.; Dennis, A.B.; Brown, J.; Timmins, P. Monitoring of multiple solvent induced form changes during high shear wet granulation and drying processes using online raman spectroscopy. Int. J. Pharm. 2018; 541: 253–260
39. Reich, G. Near-Infrared Spectroscopy and imaging: basic principles and pharmaceutical applications. Adv. Drug Deliv. Rev. 2005; 57: 1109–1143.
40. Manley, L.; Hilden, J.; Valero, P.; Kramer, T. Tablet compression force as a process analytical technology (PAT): 100% inspection and control of tablet weight uniformity. J. Pharm. Sci. 2019; 108: 485–493.
41. Clavaud, M.; Lema-Martinez, C.; Roggo, Y.; Bigalke, M.; Guillemain, A.; Hubert, P.; Ziemons, E.; Allmendinger, A. Near-infrared spectroscopy to determine residual moisture in freeze-dried products: model generation by statistical design of experiments. J. Pharm. Sci. 2020; 109: 719–729.
42. Kourti, T. The process analytical technology initiative and multivariate process analysis, monitoring and control. Anal. Bioanal. Chem. 2006; 384: 1043–1048.
43. Antosz, F.J.; Xiang, Y.; Diaz, A.R.; Jensen, A.J. The use of total reflectance x-ray fluorescence (TXRF) for the determination of metals in the pharmaceutical industry. J. Pharm. Biomed. Anal. 2012; 62: 17–22
44. Uo, M.; Wada, T.; Sugiyama, T. Applications of x-ray fluorescence analysis (XRF) to dental and medical specimens. Jpn. Dent. Sci. Rev. 2015; 51: 2–9.
45. Jenkins, R. X-ray fluorescence analysis. In x-ray characterization of materials; John Wiley and sons: Hoboken, NJ, USA, 1999; pp. 171–209.
46. Rodríguez-Hornedo, N.; Murphy, D. Significance of controlling crystallization mechanisms and kinetics in pharmaceutical systems. J. Pharm. Sci. 1999; 88: 651–660.
47. Hansuld, E.M.; Briens, L.; Sayani, A.; Mccann, J.A. Monitoring quality attributes for high-shear wet granulation with audible acoustic emissions. Powder Technol. 2012; 215: 117–123.