Rajiv Gandhi University of Health Sciences, Karnataka
First Year M. Pharm Degree Examination - Oct/Nov 2014
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Time: Three Hours Max. Marks: 100 Marks
PRODUCTION MANAGEMENT AND REGULATORY AFFAIRS
(Revised Scheme 4)
Q.P. CODE: 9383
Your answers should be specific to the questions asked.
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Draw neat labeled diagrams wherever necessary
LONG ESSAYS (Answer any Two) 2 x 20 = 40 Marks
- Elaborate the role of GMP in quality control and rational use of drug.
- Discuss the objectives, composition and functions of CDSCO.
- Discuss the elements of practice of production planning and inventory control management in pharmaceutical industry.
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SHORT ESSAYS (Answer any FIVE) 5 x 10 = 50 Marks
- What is patent infringement? Describe with a case study.
- Explain the drug regulatory affairs system in Australia.
- Discuss the procedure for filling an Abbreviated New Drug Application.
- What are ICH guidelines with respect to formulations pertaining to quality, safety and efficacy?
- Discuss the issue and challenges in pharmaceutical packing.
- Explain the importance and concept of lean manufacturing in Pharmaceutical Industry.
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SHORT NOTES 2 x 5 = 10 Marks
- Investigational New drug application.
- MHRA
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This download link is referred from the post: RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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