Author(s): Patil Divyashree Kantilal, Dhankani Amitkumar R, Dhankani Mansi A, S.P. Pawar

Email(s): divyashree2609@gmail.com

DOI: 10.52711/2231-5659.2024.00028   

Address: Patil Divyashree Kantilal1, Dhankani Amitkumar R2, Dhankani Mansi A3, S.P. Pawar4
1M.Pharm (QA), P.S.G.V.P. Mandal’s College of Pharmacy, Shahada (Maharashtra)
2Assistant Professor (Department of Pharmaceutical Quality Assurance), P.S.G.V.P. Mandal’s College of Pharmacy, Shahada (Maharashtra)
3Assistant Professor (Department of Pharmaceutics), P.S.G.V.P. Mandal’s College of Pharmacy, Shahada (Maharashtra)
4Principal of P.S.G.V.P. Mandal’s College of Pharmacy, Shahada (Maharashtra)
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2024


ABSTRACT:
This review meticulously examines the evolution and critical components of pharmaceutical plant validation, offering insights into its historical development, essential steps, and overarching significance in maintaining the quality, safety, and efficiency of drug production. It encompasses regulatory frameworks, emphasizing the alignment with current good manufacturing practices (cGMP), and delves into the different types of validation, including prospective, concurrent, retrospective, and process re-validation. The article underscores the indispensable role of validation in the pharmaceutical sector, highlighting its impact on reducing failure costs and ensuring productivity. A strategic validation approach is outlined, providing a step-by-step methodology. Overall, this article serves as a comprehensive resource for professionals seeking a nuanced understanding of the multifaceted validation processes crucial to pharmaceutical manufacturing.


Cite this article:
Patil Divyashree Kantilal, Dhankani Amitkumar R, Dhankani Mansi A, S.P. Pawar. Optimizing Pharmaceutical Processes: A Comprehensive Review of Validation Strategies for Quality, Compliance and Efficiency. Asian Journal of Research in Pharmaceutical Sciences. 2024; 14(2):177-1. doi: 10.52711/2231-5659.2024.00028

Cite(Electronic):
Patil Divyashree Kantilal, Dhankani Amitkumar R, Dhankani Mansi A, S.P. Pawar. Optimizing Pharmaceutical Processes: A Comprehensive Review of Validation Strategies for Quality, Compliance and Efficiency. Asian Journal of Research in Pharmaceutical Sciences. 2024; 14(2):177-1. doi: 10.52711/2231-5659.2024.00028   Available on: https://ajpsonline.com/AbstractView.aspx?PID=2024-14-2-12


REFERENCES:
1.    Khushboo DS et al. Sch. Acad. J. Pharm. 2014; 3(2):178-190
2.    Ana-Maria Glod-Lendvai Validation – a brief introduction GeoPatterns. 2018;  3(1): 10-15.
3.    Harpreet et.al. Journal of Drug Delivery and Therapeutics. 2013; 3(4): 189-194.
4.    Md. Shoaib Alam, et al. Pharmaceutical Process Validation: An Overview Journal of Advanced Pharmacy Education and Research.  2012; 2(4).
5.    Sudarshan Balasaheb Kakad, et.al. A Review on Pharmaceutical Validation IJPQA. 2020; 11(3).
6.    Pankaj Verma, et. Al.  A Review article on Pharmaceutical Validation and Process Controls The Pharma Innovation. Vol. 1 No. 7 2012.
7.    Lakshmana Prabu, Sakthivel and Timmakondu, Suriyaprakash and Rathinasabapathy, Thirumurugan and Alagarsamy, Shanmugarathinam. Process validation: A review. 2014; 46: 12-15.

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