Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2014 November (Master of Pharmacy) 1st Year 9383 Production Management And Regulatory Affairs Revised Scheme 4 Previous Question Paper

Rajiv Gandhi University of Health Sciences, Karnataka
First Year M. Pharm Degree Examination ? Oct/Nov 2014
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.
Draw neat labeled diagrams wherever necessary
LONG ESSAYS (Answer any Two)
2 x 20 = 40 Marks
1.
Elaborate the role of GMP in quality control and rational use of drug.
2.
Discuss the objectives, composition and functions of CDSCO.
3
Discuss the elements of practice of production planning and inventory control management
in pharmaceutical industry.
SHORT ESSAYS (Answer any FIVE)
5 x 10 = 50 Marks
4.
What is patent infringement? Describe with a case study.
5.
Explain the drug regulatory affairs system in Australia.
6.
Discuss the procedure for filling a Abbreviated New Drug Application.
7.
What are ICH guidelines with respect to formulations pertaining to quality, safety and
efficacy?
8.
Discuss the issue and challenges in pharmaceutical packing.
9.
Explain the importance and concept of lean manufacturing in Pharmaceutical Industry.
SHORT NOTES
2 x 5 = 10 Marks
10.
Investigational New drug application.
11.
MHRA
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