Pharmaceutical Process Validation: A Review
Abstract
Pharmaceutical industries are in now their peak period. There is a need to ensure that pharmaceutical process validations are being done so well and results we obtain is reproducible. Results simply ensure product items consistency. These validations must be done in such a way that final product satisfies all of requirements, is very necessary in pharmaceutical field. Whatever will be the product or whatever will be the protocols, important prerequisite is Quality. Process validation signifies the values of analytical tools, analytical procedures, objective measures and it gives attention towards Knowledge, Detection and control on variabilities So as to assure quality throughout the life cycle of product. The object of this article is to explain the enormous utilities of process validation and their need, methods. This process validation assures the delivery of product just like predetermined. Without the process validation one cannot expect the precision in results.
Keywords: PV- Process validation, CV- Concurrent validation, RV- Retrospective validation
Keywords:
PV- Process validation, CV- Concurrent validation, RV- Retrospective validationDOI
https://doi.org/10.22270/jddt.v12i1-S.5316References
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.
Oechslein C, Lazar M. S – Process Validation from view report of the FDA, Maas & Peither AG – GMP Publishing, LOGFILE No. 3/ February 2012.
Quality Management System – Process Validation Guidance GHTF/SG3/N99-10:2004 (Edition 2).
Nash R. A and Wachter A. H, Pharmaceutical Process Validation an International Third Edition. Revised and expanded, Marcel Dekkar, Inc., New York, 2003; 17 – 40. https://doi.org/10.1201/9780203912119
Patel R. C, Bhuva C. K, Singh R. P, Dadhich A, Sharma A., - Pharmaceutical Process Validation, Pharma tutor – ART – 1053.
Kathiresan K*, Moorthi C, Prathyusha Y, Gade B. R, Reddy B. K, Manavalan R, An overview of pharmaceutical validation; Research Journal of Pharmaceutical, Biological and Chemical Sciences; 2010; 1(4):1026.
Pharmaceutical Process Validation: Guide to Inspections of Oral Solid Dosage Forms pre/post Approval Issue for Development and Validation; issue (1/94); January, 2010.M8.
Green JM. A Practical Guide to Analytical Method Validation, Anal. Chem. News and Features 1996; 60:305A-9A. https://doi.org/10.1021/ac961912f
Akers, J. Simplifying and improving process validation. J. Parent. Sci. Technol. 1993, 47, 281–284.
Avallone, H.L.; D‟Eramo, P. Scale-up and validation of ANDA/NDA products. Pharm. Eng.1992, 12 (6):36–39.
Chowhan, Z.T. Development of a new drug substance into a compact tablet. Pharm. Technol.1992, 16 (9):58–67.
Nash RA. Process Validation of a 17-Year retrospective study of solid dosage forms Drug DevInd Pharm 1966; 22 (1):25-34. https://doi.org/10.3109/03639049609043869
Therapeutics Products Programme. Process Validation: Aseptic Processes for Pharmaceuticals. http://www.hc-sc.gc.ca/hpbdgps/therapeutic; downloaded March 30, 2001.
Lambert J. Validation Guidelines for Pharmaceutical Dosage Forms. Health Canada / Health Products and Food Branch Inspectorate; 2004. pp. 7-15.
Gupta GD, Garg R, Aggarwal S. Guidelines on General Principles of Validation: Solid, Liquid and Sterile dosage forms. Pharm Sci Tech, 2008; 6:28-33
Dashora K, Singh D, Saraf S. Validation – the Essential Quality Assurance Tool for Pharma Industries. Pharminfo, 2005; 3:45-47.
FDA Guidance Update: process Validation: General Principles and Practices; version 01; 2009.
Validation Master Plan Installation and Operational Qualification – Pharmaceutical Inspection Convention; Pharmaceutical Inspection Co-Operation Scheme; PI 006 – 2; July, 2004.
Kiffer,R.G, J. Pharma. sic. tec., 1995, 44, 5, p.249.
Kumar NL, MoorthyDG, Kumar RS, Sekaran CS. An overview of pharmaceutical validation: quality assurance view point, 2011; 1(4):1003-1014.
Agalloco J. The validation life cycle. J ParenterSci Technol. 1993; 47(3):142-147.
Sharp JR. The Problems of Process Validation. Pharm J 1986; 1:43-5.
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