December 2016 ARTICLE LIST >>
PharmaTutor (December - 2016)
ISSN: 2347 - 7881
(Volume 4, Issue 12)
Received On: 06/07/2016; Accepted On: 09/08/2016; Published On: 01/12/2016
AUTHORS:
Surya Pratap Singh *, Kailash Dhaker, Abhisek Namdev, Mahaveer Prasad Khinchi, Surbhi Bhatnagar
Department of pharmaceutics, Kota College of Pharmacy, Kota, Rajasthan, India
sp.kota91@gmail.com
ABSTRACT: Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Basically, Process validation emphasize the role of objective measure and statistical tools and analyses knowledge, detection, and control of variability and give assurance on consistent of quality / productive throughout life cycle of product. Result from Process validation method can be used to judge the quality and consistency of analytical result. The purpose of this review to cover need of process validation, principle of process validation, type of process validation, phase of process validation, strategy for process validation. In this review article we discussed about the importance and strategy of validation of analytical procedure.
How to cite this article: Singh SP, Dhaker K, Namdev A, Khinchi MP, Bhatnagar S;A Review on Process Validation; PharmaTutor; 2016; 4(12); 9-19
[ABSTRACT WITH CITATION] [VIEW AS HTML]
REFERENCES:
1. Sharma Ajay , Sharma Rohit “Validation of analytical procedure :a comparison of ICH Vs pharmacopeia” irjp.2012,3(6);39-42.
2. Nash Robert A., Wachter Alfred H “pharmaceuticals processes Validation”. Drugs and the pharmaceutical sciences.1993, 29; 438.
3. World Health Organization. Guidelines on the Validation of Manufacturing Processes.1993.
4. M.J. Green, Anal. Chem’ Analytical Methods Validation’., 1996,68;305
5. G.A. Shabir, J. Chromatogra. ;Analytical Methods Validation”.2003,987;57.
6. Himanshu ,pahuja Sonia “A review on pharmaceutical process validation “’international research journal of pharmacy” irjp 2012.
7. Keyurb.ahir ,khushbood.sing ,hetals.patel “Overview of validation and basic concept of process validation”scholar academic journal of pharmacy 2014,3(2);178-190.
8. Nandhakumar L., DharmamoorthyG.,Rameshkumar S and Chandrasekaran S. “An Overview of Pharmaceutical Validation: Quality Assurance View Point” International journal of research in pharmacy and chemistry .2011,1(4);12.
9. Ravichandranv ,shalini s, harishrajak “Validation analytical method strategies &importance”International journal of pharmacy and pharmaceutical science. 2010,2;120-139.
10. Lower Stephen K. “Introduction pharmaceutical solution’ journal of pharmaceutical;2013;43;558-565.
11. FrantsitsWerner“Pharmaceutical solutions for oral administrationjournalof pharmaceutica.1999;39(12).
12. Nandhakumar L., DharmamoorthyG.,Rameshkumar S and Chandrasekaran S. “An Overview of Pharmaceutical Validation: Quality Assurance View Point” International journal of research in pharmacy and chemistry .2011,1(4);12.
13. Md. ShoaibAlam Pharmaceutical Process Validation: An Overview. Journal of Advanced Pharmacy Education & Research. 2012,2(4);185-200.
14. Nash R. A and Wachter A. H, “Pharmaceutical Process Validation an International” Drugs and the pharmaceutical sciences. 2003,3; 17 – 40.
15. 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; ISSN: 0975-8585; October – December 2010; RJPBCS 1(4);1026.
16. Md. ShoaibAlam Pharmaceutical Process Validation: An Overview. Journal of Advanced Pharmacy Education & Research. 2012, 2(4); 185-200.
17. U.S. Food and Drug Administration. Guidelines on General Principles of Process Validation. 1987.
18. Sanjay Bajaj, Dinesh Singla and NehaSakhuja’ Stability Testing of Pharmaceutical Products’ Journal of Applied Pharmaceutical Science 02 (03); 2012: 129-138.
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