Author(s): Shrutika Gaikwad, Someshwar Mankar


DOI: 10.52711/2231-5675.2024.00007   

Address: Shrutika Gaikwad, Someshwar Mankar
Department of Pharmaceutics, Pravara Rural College of Pharmacy, Pravaranagar.
*Corresponding Author

Published In:   Volume - 14,      Issue - 1,     Year - 2024

Quality is always chosen with specific intention by any industry for its products manufactured. Obtaining the desired quality is always a difficult task for any pharmaceutical industry. For the pharmaceutical sector, achieving the appropriate quality is always a challenging undertaking. The art of developing and putting the planned actions into practice in addition to the documentation is known as validation. Together, validation and quality assurance will guarantee the items' overall quality. Process design factors related to FPR producing a high-quality product for any industry are the primary focus of process validation. Maintaining process control during each batch's commercialization is another aspect of process validation. A dosage form is a chemical compound's physical dosage that is part of a formulation that can be manufactured on a wide scale with consistent product quality and is meant to produce a predictable therapeutic response in medicine. Achieving and sustaining the quality of the final product at every point of its life cycle, not just the finish, depends in large part on validation. This article provides a general introduction and summary of the significance of process validation in the manufacturing of pharmaceuticals.

Cite this article:
Shrutika Gaikwad, Someshwar Mankar. A Brief Review on Process Validation and its Types. Asian Journal of Pharmaceutical Analysis. 2024; 14(1):33-8 doi: 10.52711/2231-5675.2024.00007

Shrutika Gaikwad, Someshwar Mankar. A Brief Review on Process Validation and its Types. Asian Journal of Pharmaceutical Analysis. 2024; 14(1):33-8 doi: 10.52711/2231-5675.2024.00007   Available on:

1.    Arden NS, Fisher AC, Tyner K, Yu LX, Lee SL, Kopcha M. Industry 4.0 for Pharmaceutical Manufacturing: Preparing for the smart factories of the future. Int J Pharm. 2021; 602: 120554. doi:10.1016/j.ijpharm.2021.120554
2.    Pramod K, Tahir Ma, Charoo N, Ansari S, Ali J. Pharmaceutical product development: A quality by design approach. Int J Pharm Investig. 2016; 6(3): 129. doi:10.4103/2230-973X.187350
3.    Yu LX, Amidon G, Khan MA, et al. Understanding Pharmaceutical Quality by Design. AAPS J. 2014; 16(4): 771-783. doi:10.1208/s12248-014-9598-3
4.    Petrelli F, Caraffa A, Scuri S, Grappasonni I, Magrini E, Cocchini A. The requirements for manufacturing highly active or sensitising drugs comparing good manufacturing practices. Acta Biomedica. 2019; 90(2): 288-299. doi:10.23750/abm.v90i2.8340
5.    Kumar Raul S, Krishna Padhy G, Kumar Mahapatra A, Alekha Charan S. An Overview of Concept of Pharmaceutical Validation. Research J Pharm and Tech. 2014; 7(9).
6.    M Sreenivasa G, T Sriranga, Banakar N, Kori V, Vasanad C, P PavankumarS. Process Validation in Pharmaceutical Product Development: An Overview. Journal of Biomedical and Pharmaceutical Research. 2021; 10(5). doi:10.32553/jbpr.v10i5.883
7.    Sharma S, Singh G. Process Validation In Pharmaceutical Industry; An Overview. Journal of Drug Delivery and Therapeutics. 2013; 3(4). doi:10.22270/jddt.v3i4.582
8.    Jadhav A, Salunkhe V, Magdum C. An Overview of Pharmaceutical Process Validation of Solid Dosage Form.
9.    Harpreet K, Gurpreet S, Nimrata S. Pharmaceutical Process Validation: A Review. Journal of Drug Delivery and Therapeutics. 2011; 2013(3):189.
10.    Sharma M, Agarwal S, Agarwal S, Sharma M. Prospective Validation: A Review. The Pharma Innovation Journal. 2015; 4(3): 1-7   
11.    Bharkatiya M, Jain K, Agarwal P. A Review on Pharmaceutical validation and its Implications. Article in International Journal of Pharmacy and Biological Sciences. 2018; 8(2): 117-126.  
12.    Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of Validation and Basic Concepts of Process Validation. Scholars Academic Journal of Pharmacy. 2014; 3(2): 178-190.  
13.    Jindal D, Kaur H, Patil RK, Patil HC. Validation–In pharmaceutical industry: Equipment validation: A brief review. Adesh University Journal of Medical Sciences and Research. 2020; 2: 94-98. doi:10.25259/aujmsr_15_2020
14.    Gupta NV, Padickakunnel GS. Modern FDA Guidance and Comparative Overview of FDA and EMA on Process Validation. 2014.
15.    Todde S, Peitl PK, Elsinga P, et al. Guidance on validation and qualification of processes and operations involving radiopharmaceuticals. EJNMMI Radiopharm Chem. 2017; 2(1): 8. doi:10.1186/s41181-017-0025-9
16.    Patil BN, Tippavajhala VK, Pai KG. Equipment Qualification of a New Laboratory Tray Dryer. Res J Pharm Technol. 2019; 12(2): 805. doi:10.5958/0974-360X.2019.00140.9
17.    Lionberger RA, Lee SL, Lee L, Raw A, Yu LX. Quality by Design: Concepts for ANDAs. AAPS J. 2008; 10(2): 268-276. doi:10.1208/s12248-008-9026-7

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