An Updated and Modern Concept of Validation
Keywords:
Validation, Quality, Pharmaceutical
Abstract
Validation is a very important tool in GMP. Main aim and objective of GMP to all Pharmaceutical agencies are to provide a good and reasonable quality of Pharmaceutical products to people. To get that desired quality Validation is great support to all Pharmaceutical and other industry people. Validation is also a very important tool to save money, time, labourer, waste material etc. There are different types of Validation used all over the world by which we can achieve our goal very easily. In this review it is briefly described scope, importance, objectives and types of Validation as per international norms. Now days it became so important that without validation any process, method or instrument are not accepted globally.
References
1. R. A. Nash, A. H. Watcher: A Pharmaceutical process Validation, Marcel Dekker Inc., New York, 2003.
2. M. Potdar Current Good Manufacturing Practices, Pharma book Syndicate, Hydrabad, 2006.
3. S. I. Haider , Pharmaceutical Master Validation Plan: the ultimate guide to FDA, GMP and GLP compliance: C R C press, Florida, 2001.
4. http://www.validation-online.net/process-qualification.html
5. Sravya K., Jena S. B., Goje A., Prasad D. N.; Equipment Qualification for RMG, FBD, Blender & Compression Machines-An Overview; Int. J. of Pharmacy & Biotechnology Technology; 2011; 1(3); 190-200.
6. Vogel’s: The text book of quantitative chemical analysis, Pearson Education, 1145-52.
7. G. R. Chatwal: Pharmaceutical chemistry-inorganic, Himalaya Publishing House, New delhi 18-26.
8. http://www.chromatographyonline.com.
9. L. Nandhakumar, G. Dharmamoorthy, S. Rameshkumar and S. Chandrasekaran; An overview of pharmaceutical validation: quality assurance view point; Int. J. of research in pharmacy and chemistry; 2011; 1(4); 1004-1014.
10. http://www.apic.cefic.org/pub/4CleaningVal9909.pdf
11. http:// www.personnel validation\detailmini.jsp.htm
2. M. Potdar Current Good Manufacturing Practices, Pharma book Syndicate, Hydrabad, 2006.
3. S. I. Haider , Pharmaceutical Master Validation Plan: the ultimate guide to FDA, GMP and GLP compliance: C R C press, Florida, 2001.
4. http://www.validation-online.net/process-qualification.html
5. Sravya K., Jena S. B., Goje A., Prasad D. N.; Equipment Qualification for RMG, FBD, Blender & Compression Machines-An Overview; Int. J. of Pharmacy & Biotechnology Technology; 2011; 1(3); 190-200.
6. Vogel’s: The text book of quantitative chemical analysis, Pearson Education, 1145-52.
7. G. R. Chatwal: Pharmaceutical chemistry-inorganic, Himalaya Publishing House, New delhi 18-26.
8. http://www.chromatographyonline.com.
9. L. Nandhakumar, G. Dharmamoorthy, S. Rameshkumar and S. Chandrasekaran; An overview of pharmaceutical validation: quality assurance view point; Int. J. of research in pharmacy and chemistry; 2011; 1(4); 1004-1014.
10. http://www.apic.cefic.org/pub/4CleaningVal9909.pdf
11. http:// www.personnel validation\detailmini.jsp.htm
Published
2015-06-01
How to Cite
[1]
Ghosh, S., Ravikumar, B. and Mahant, B. 2015. An Updated and Modern Concept of Validation. PharmaTutor. 3, 6 (Jun. 2015), 16-20.
Section
Articles
