Author(s):
Samsuddin Ansari, Ankit Kumar, Manju Prajapati, Janki Prasad Rai
Email(s):
samsuddinansari2078@gmail.com , singhankitkumar86@gmail.com , manjuprajapati31@gmail.com , Jp.monu@gmail.com
DOI:
10.52711/2231-5713.2024.00041 
Address:
Samsuddin Ansari1, Ankit Kumar2, Manju Prajapati3, Janki Prasad Rai4
1Practitioner, Bachelor of Pharmacy, School of Pharmacy, LNCT University, Bhopal, MP, India.
2Student, Bachelor of Pharmacy, School of Pharmacy, LNCT University, Bhopal, MP, India.
3Professor, School of Pharmacy, LNCT University, Bhopal, MP, India.
4Professor, School of Pharmacy, LNCT University, Bhopal, MP, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 3,
Year - 2024
ABSTRACT:
This article provides an introduction and a brief of process validation in the pharmaceutical manufacturing process. Process validation deals with process design aspects and maintaining process control during commercialization. It also conveys that process validation is an ongoing program and aligns process validation activities with the product life cycle. When considering any product, quality is always a mandatory must-have. As a result, drugs must be produced with the greatest quality requirements. Process validation is a key stage in assessing and maintaining the quality of the final product. This article goes over the following topics: introduction, validation type, prospective validation, retrospective validation, concurrent validation, revalidation validation, process validation elements, documentation, validation master plan, validation methodology, and validation report. Process validation also emphasizes the role of objective statistics, statistical tools, and analyses, as well as understanding, identification, and control of variability, and assures consistent quality/productivity throughout the product's lifecycle. The validation research establishes and documents the accuracy, sensitivity, specificity, and repeatability of the firm's test techniques. Thus, validation is a vital component of quality assurance. In recent years, the importance of validation has grown significantly.
Cite this article:
Samsuddin Ansari, Ankit Kumar, Manju Prajapati, Janki Prasad Rai. A Review on Pharmaceutical Process Validation. Asian Journal of Pharmacy and Technology. 2024; 14(3):251-6. doi: 10.52711/2231-5713.2024.00041
Cite(Electronic):
Samsuddin Ansari, Ankit Kumar, Manju Prajapati, Janki Prasad Rai. A Review on Pharmaceutical Process Validation. Asian Journal of Pharmacy and Technology. 2024; 14(3):251-6. doi: 10.52711/2231-5713.2024.00041 Available on: https://ajptonline.com/AbstractView.aspx?PID=2024-14-3-10
REFERENCES:
1. Rockville M D. Guideline on General Principles of Process Validation. U.S. Food and Drug Administration., U.S. FDA: 2010.
2. Shelendra Kumar Manglavat, Deepak Kumawat, Raksha Goswami. Process Validation for Antiviral Famciclovir tablet. Asian J. Pharm. Tech. 2020; 10(3):170-178.
3. Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 2016; 6(4): 201-206.
4. Sharma A, Saini S. Process Validation of Solid Dosage Form: A Review. International Journal of Research in Pharmacy and Science. 2013; 3(2):12- 30.
5. Paruchuri R, Trivedi S, Pavuluri G, Prasanthi B and Kumar S. Process Validation of Finasteride Tablets. International Journal of Pharmaceutical, Chemical and BiologicalSciences, 2012; 2(1): 11-28.
6. Parida R. Overview of Pharmaceutical Validation and Process Controls in Drug Development. Pelagia Research Library. 2010; 1(1): 11-19.
7. H. S. Jumde, S. D. Mankar. Review on development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography. Asian Journal of Pharmacy and Technology. 2022; 12(2):179-2.
8. Priyanka Kailas Borse, Kiran B. Dhamak. Process Validation of Isoniazide and Rifampin Tablet. Asian Journal of Pharmacy and Technology. 2021; 11(2):105-0.
9. Nash RA. Process Validation of a 17- Year retrospective study of solid dosage forms. Drug Dev Ind Pharm. 1966; 22 (1): 25-34.
10. Yogita Chowdhary, Babita Kumar. SUPAC- Post Approval Changes suggested by FDA to Industry. Asian Journal of Research in Pharmaceutical Sciences. 2023; 13(1):29-2. doi: 10.52711/2231-5659.2023.00005
11. Validation of Solid Dosage Forms the FDA view. 1989; 15(6-7): 1119-1133.
12. S. Janet Beula, R. Suthakaran, Y. Ramulu, M. Viswaja, G. Venkateswaralu. A Review on Cleaning Validation-Regulatory Guidelines for The Pharmaceutical Industry. Asian Journal of Pharmaceutical Research. 2022; 12(2):167-0.
13. Prajkta M. Ghagare, Ashwini R. Patil, Bhavna J. Deshmane, Manish S. Kondawar. Review on Pharmaceutical Validation. Res. J. Pharma. Dosage Forms and Tech. 2020; 12(1): 17-26.
14. Guidance for Industry: Process Validation: General Principles and Practices. U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), Centre for Veterinary Medicine (CVM). January 2011.
15. Guidelines for Process Validation of Pharmaceutical Dosage Form – Saudi Food & Drug Authority; Version 2; February, 1992.
16. Soumesh Kumar Tripathy. Pharmaceutical Validation: A Quality Maintaining Tool for Pharmaceutical Industry. Asian J. Pharm. Res. 2020; 10(4):307-311.
17. Abdul Saleem Mohammad, Swetha Devidi, Nikhat Fatima, Humera Badar, Syeda Saba Sulthana, Mohammad Akthar Sulthana, Nuha Rasheed. An Overview of Validation and Basic Concepts of Process Validation: Quality Assurance View Point. Asian J. Pharm. Tech. 2016; 6 (3): 169-176.
18. Oechslein C, Lazar MS; Process Validation from view report of the FDA. Maas and Peither AG – GMP Publishing, Logfile No. 3/ February 2012.
19. Guidance for Industry on general principles and practices of process validation; US Department of Health and Human Services, Food and Drug Administration. 2011; 7-9.
20. Validation Guidelines for Pharmaceutical Dosage Form; Health products and Food branch Inspectorate, Canada, December 2009; 8-13.
21. Rockville MD; Guide to Inspections of Oral Solid Dosage Forms pre/post Approval Issue for D28. U.S. Food and Drug Administration.
22. Process Validation: An Overview. Process Validation: An Overview. Research J. Pharma. Dosage Forms and Tech. 2011; 3(6): 247-250.
23. Loftus BT. The Regulatory Basis for Process Validation. Pharmaceutical Process Validation. Vol. 23, Marcel Dekker, New York, 1984: 1–7.
24. South African Guide to Good Manufacturing Practice. Pretoria: Medicines Control Council, 1996.
25. Good Manufacturing Practices for Pharmaceutical products, WHO Expert Committee on Specifications for Pharmaceutical Preparations, 32nd Report, WHO Technical Report Series no. 823, WHO, Geneva, 1992: 14-96.