Author(s): Arti Swami, Shivani Chakankar, Prajakta Chavan, Dnyanesh Limaye, Amol Tagalpallewar


DOI: 10.52711/0974-360X.2023.00724   

Address: Arti Swami*, Shivani Chakankar, Prajakta Chavan, Dnyanesh Limaye, Amol Tagalpallewar
Department of Pharmaceutical Sciences, School of Health Sciences and Technology, D. Vishwanath Karad MIT World Peace University, Sr.No. 124, MIT Campus Paud Road, Kothrud, Pune, Maharashtra 411038.
*Corresponding Author

Published In:   Volume - 16,      Issue - 9,     Year - 2023

Quality of pharmaceutical product is of principle importance by all the regulatory bodies. Failure to meet such quality expectations can lead to massive shift of pharmaceutical companies in share of market. The pharmaceutical industry is supremely regulated industry as it is managed by convincing regulatory bodies. Process analytical technology (PAT) is a method to plan, examine and regulate pharmaceutical manufacturing procedures by examining critical process parameters influencing the critical quality attributes. PAT has been used in manufacturing processes in pharmaceutical industries from decades. PAT involves utilizing diverse techniques and tools to construct quality in pharmaceutical products both physically and chemically by testing at one or more intermediate processing steps. This review endeavors to discover perception tools, goal line, PAT tools in manufacturing, its working and applications, regulatory considerations and benefits. The applications of NIR spectroscopy have extended the added advantages in pharmaceutical industry.

Cite this article:
Arti Swami, Shivani Chakankar, Prajakta Chavan, Dnyanesh Limaye, Amol Tagalpallewar. A Critical Review on Recently Used PAT in Pharmaceutical Industry. Research Journal of Pharmacy and Technology 2023; 16(9):4436-2. doi: 10.52711/0974-360X.2023.00724

Arti Swami, Shivani Chakankar, Prajakta Chavan, Dnyanesh Limaye, Amol Tagalpallewar. A Critical Review on Recently Used PAT in Pharmaceutical Industry. Research Journal of Pharmacy and Technology 2023; 16(9):4436-2. doi: 10.52711/0974-360X.2023.00724   Available on:

1.    Murphy T, O’ Mahony N, Panduru K, Riordan D, Walsh J. Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach. In 2016. p. 1–7.
2.    Raj P, Gupta NV. Process analytical technology (PAT): A real time quality assurance. Int J Pharm Sci Rev Res. 2016 Jan 1;37:67–72.
3.    Scott B, Wilcock A. Process Analytical Technology and Validation. In: Validation of Pharmaceutical Processes, Third Edition. 2007. p. 583–605.
4.    Poozesh M, Ghasemzadeh H, Ablollahpour S, Diva MA. Effect of DL-Methionine Concentration, Moisture Content and Bulk Density of Animal Feed on the Light-Induced Fluorescence as a Process Analytical Tool. 2020;16.
5.    Process Analytical Technology (PAT) in Pharmaceutical Development [Internet]. [cited 2021 May 14]. Available from:
6.    Frontiers | Editorial: Freeze-Drying and Process Analytical Technology for Pharmaceuticals | Chemistry [Internet]. [cited 2021 May 7]. Available from: articles/10.3389/fchem.2018.00622/full
7.    Process Analytical Technologies | BCC Research [Internet]. [cited 2021 May 14]. Available from:
8.    Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, manufacturing, and Quality Assurance. :19.
9.    Pomerantsev AL, Rodionova OY. Process analytical technology: a critical view of the chemometricians. J Chemom. 26(6):299–310.
10.    Pauli V, Roggo Y, Pellegatti L, Nguyen Trung NQ, Elbaz F, Ensslin S, et al. Process analytical technology for continuous manufacturing tableting processing: A case study. J Pharm Biomed Anal. 2019 Jan 5;162:101–11.
11.    Patel BA, Pinto NDS, Gospodarek A, Kilgore B, Goswami K, Napoli WN, et al. On-Line Ion Exchange Liquid Chromatography as a Process Analytical Technology for Monoclonal Antibody Characterization in Continuous Bioprocessing. Anal Chem. 2017 Nov 7;89(21):11357–65.
12.    Chanda A, Daly AM, Foley DA, LaPack MA, Mukherjee S, Orr JD, et al. Industry Perspectives on Process Analytical Technology: Tools and Applications in API Development. Org Process Res Dev. 2015 Jan 16;19(1):63–83.
13.    Mali A, Jagtap M, Karekar P, Maruska A. A BRIEF REVIEW ON PROCESS ANALYTICAL TECHNOLOGY (PAT) Review Article. Int J Curr Pharm Rev Res. 2016 Jan 1;8:10–5.
14.    Dille MJ, Hattrem MN, Draget KI. Soft, chewable gelatin-based pharmaceutical oral formulations: a technical approach. Pharm Dev Technol. 2018 May 28;23(5):504–11.
15.    Ramachandran A, Jaeschke H. Acetaminophen Hepatotoxicity. Semin Liver Dis. 2019 May;39(2):221–34.
16.    Xu P, Zhang J, Bandari S, Repka MA. A Novel Acetaminophen Soft-Chew Formulation Produced via Hot-Melt Extrusion with In-line Near-Infrared Monitoring as a Process Analytical Technology Tool. AAPS PharmSciTech. 2020 Jan 2;21(2):37.
17.    Blanco M, Villarroya I. NIR spectroscopy: a rapid-response analytical tool. TrAC Trends Anal Chem. 2002 Apr 1;21(4):240–50.
18.    Pfister D, Morbidelli M. Process for protein PEGylation. J Controlled Release. 2014 Apr 28;180:134–49.
19.    Hebbi V, Thakur G, Rathore A. Process analytical technology application for protein PEGylation using near infrared spectroscopy: G-CSF as a case study. J Biotechnol. 2020;325.
20.    Kim Y-I, Pradhan R, Paudel BK, Choi JY, Im HT, Kim JO. Preparation and evaluation of enteric-coated delayed-release pellets of duloxetine hydrochloride using a fluidized bed coater. Arch Pharm Res. 2015 Dec 1;38(12):2163–71.
21.    Advances in hot-melt extrusion technology toward pharmaceutical objectives | SpringerLink [Internet]. [cited 2021 May 14]. Available from:
22.    Vo AQ, Kutz G, He H, Narala S, Bandari S, Repka MA. Continuous Manufacturing of Ketoprofen Delayed Release Pellets Using Melt Extrusion Technology: Application of QbD Design Space, Inline Near Infrared, and Inline Pellet Size Analysis. J Pharm Sci. 2020 Dec 1;109(12):3598–607.
23.    Krajisnik D, Milić J. Polymer-stabilized emulsion systems: structural characteristics and physical stability evaluation. Drug Dev Ind Pharm. 2003 Jul; 29(6):701–11.
24.    Continuous Manufacturing of a Polymer Stabilized Emulsion Monitored with Process Analytical Technology | SpringerLink [Internet]. [Cited 2021 May 8]. Available from:
25.    O’Donnell C, Fagan C, Cullen PJ. Process Analytical Technology for the Food Industry. 2014.
26.    Challa S, Potumarthi R. Chemometrics-Based Process Analytical Technology (PAT) Tools: Applications and Adaptation in Pharmaceutical and Biopharmaceutical Industries. Appl Biochem Biotechnol. 2012 Nov 10; 169.
27.    Henriques J, Sousa J, Veiga F, Cardoso C, Vitorino C. Process analytical technologies and injectable drug products: Is there a future? Int J Pharm. 2019 Jan 10; 554:21–35.
28.     Feng H, Mohan S. Application of Process Analytical Technology for Pharmaceutical Coating: Challenges, Pitfalls, and Trends. AAPS PharmSciTech. 2020 Jun 28; 21(5):179.
29.    Shaikh R, O’Brien DP, Croker DM, and Walker GM. Chapter 2 - The development of a pharmaceutical oral solid dosage forms. In: Singh R, Yuan Z, editors. Computer Aided Chemical Engineering [Internet]. Elsevier; 2018 [cited 2021 May 14]. p. 27–65. (Process Systems Engineering for Pharmaceutical Manufacturing; vol. 41). Available from:
30.    Wu H, White M, Khan MA. Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development. Int J Pharm. 2011 Feb 28; 405(1):63–78.
31.    Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing | SpringerLink [Internet]. [Cited 2021 May 8]. Available from:
32.    Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arab J Chem. 2017 May 1; 10:S3412–25.
33.    Boeckx J, Page TG, WALDRON MS. Tablet production module and method for continuous production of tablets [Internet]. US9713575B2, 2017 [cited 2021 May 14]. Available from:
34.    Kramer H, Trebbi R. Tablettenpresse [Internet]. DE60212084T2, 2006 [cited 2021 May 14]. Available from:
35.    WernerF, Pollard S. Dichtvorrichtung einer Tablettenpresse sowie Tablettenpresse mit einer Dichtvorrichtung [Internet]. DE102017214157A1, 2019 [cited 2021 May 14]. Available from:
36.    TSUJIURA Y, Fujii Y. Rotary compression molding machine [Internet]. EP3792050A1, 2021 [cited 2021 May 14]. Available from:
37.    Zahrah TF, Raman R, Parrish PA, Rowland R. Fluidizing method and apparatus [Internet]. US6764296B2, 2004 [cited 2021 May 14]. Available from:
38.    PAT – reducing the cost of quality in consumer products manufacturing. Eur Pharm Rev [Internet]. [Cited 2021 May 14]; Available from:

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