Role of Quality Assurance Department in Pharmaceutical Industries: A Review
Abstract
The overview of the Quality Assurance Department in Pharmaceutical Industry is well discussed. It explains the vital role and the objectives of Quality Assurance Department. It also explains on how Quality Assurance can increase the revenue of the industry and how it is related to the other department as an important factor. This review gives the information about the role of Higher management and Importance of Quality Assurance in Pharmaceutical industry. It gives clear idea on how Quality Assurance Department works. The role of the Quality Assurance in Validation, Regulatory Affairs, and also in Business Development is explained.
Keywords: Quality Assurance, Regulatory Affairs, Objective, Importance, GMP.
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References
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https://www.academia.edu/8865972/An_Overview_of_Quality_Assurance_Department_in_the_Pharmaceutical_Industry
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11. Medicines and Healthcare Products Regulatory Agency (MHRA): Rules and Guidance for Pharmaceutical manufacturers and Distributors. Pharmaceutical press, London; 2007.
12. Cruz L, Cruz F, Ashwinder Singh: Vital role of Quality Assurance as a Backbone in Pharmaceutical Industry. International Journal of Advances in Pharmaceutics 2015; 4:104-110.
13. Smith, M. C. Principles of pharmaceutical marketing. Routledge 2014.
14. Huber, L. Validation of analytical methods. Validation and Qualification in the Analytical Laboratories. Interpharm Press; 1998; 107.
15. Agalloco, J. P., Carleton, F. J. (Eds.). Validation of pharmaceutical processes. CRC Press; 2007.
16. Cockburn, I. M. The changing structure of the pharmaceutical industry. Health Affairs 2004; 23(1):10-22.
17. Carpenter, D. P. The political economy of FDA drug review: processing, politics, and lessons for policy. Health Affairs 2004; 23(1):52-63.
https://www.academia.edu/8865972/An_Overview_of_Quality_Assurance_Department_in_the_Pharmaceutical_Industry
2. Dr. Shabir GA, Higher Management Role and Importance of Quality Assurance in the Pharmaceutical Industry. September 30, 2013.
3. Banker G. S., Siepmann J., & Rhodes, C. (Eds.). Modern pharmaceutics. CRC Press; 2002.
4. Guideline, I. H. T. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Q7A, Current Step, 2000: 4.
5. Cardinal, L. B. Technological innovation in the pharmaceutical industry: The use of organizational control in managing research and development. Organization science, 2001; 12(1):19-36.
6. What is the Role of Quality Assurance in the Pharmaceutical Industry. Oct 4, 2016. Available from www.cafepharm.com/cpwire/Article .
7. Sower, Victor E. Essential of Quality with cases and experiential exercises. New York; John Wiley and Sons; 2011.
8. Quality Assurance of Pharmaceutics: a compendium of guide lines and related materials. Volume 2. GMP and Inspection. 2nd ed. WHO Press; 2007.
9. The Role of Quality Assurance in the Pharmaceutical Industry. Available from http://www.rscal.com/role-quality-assurance-pharmaceutical-industry/
10. International Conference on Harmonization (ICH), Food and Drug Administration (FDA), Guidance for Industry, Q10: Pharmaceutical Quality Systems, April 2009.
11. Medicines and Healthcare Products Regulatory Agency (MHRA): Rules and Guidance for Pharmaceutical manufacturers and Distributors. Pharmaceutical press, London; 2007.
12. Cruz L, Cruz F, Ashwinder Singh: Vital role of Quality Assurance as a Backbone in Pharmaceutical Industry. International Journal of Advances in Pharmaceutics 2015; 4:104-110.
13. Smith, M. C. Principles of pharmaceutical marketing. Routledge 2014.
14. Huber, L. Validation of analytical methods. Validation and Qualification in the Analytical Laboratories. Interpharm Press; 1998; 107.
15. Agalloco, J. P., Carleton, F. J. (Eds.). Validation of pharmaceutical processes. CRC Press; 2007.
16. Cockburn, I. M. The changing structure of the pharmaceutical industry. Health Affairs 2004; 23(1):10-22.
17. Carpenter, D. P. The political economy of FDA drug review: processing, politics, and lessons for policy. Health Affairs 2004; 23(1):52-63.
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How to Cite
1.
Saudagar R, Doltade M. Role of Quality Assurance Department in Pharmaceutical Industries: A Review. JDDT [Internet]. 15May2019 [cited 14Apr.2021];9(3):678-83. Available from: http://jddtonline.info/index.php/jddt/article/view/2904
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Review
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