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Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination – October 2010
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[Time: 3 Hours]
[Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(Revised Scheme 2)
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Q.P. CODE : 9293
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Explain in detail about the concept and Philosophy of GMP. Add a note on cGMP and Patent Regime.
- Write a detailed note about the layout and good warehousing practices in pharmaceutical industries.
- Write a note on salient features of Consumer protection Act, Environmental Protection Act and Factory Act.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write a note on present status and scope of pharmaceutical industry in India.
- Write a note on EXIM policy
- Write a note on GLP protocols on clinical testing.
- Write a note on concepts of loan licensing and contract manufacture.
- Explain in detail the procedures followed for the disposal of waste and scrap.
- Write a note on recovered materials and reprocessing.
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SHORT NOTES 2 X 5 = 10 Marks
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- Philosophy of GLP.
- Write a note on Controls on Animal House.
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