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Rajiv Gandhi University of Health Sciences, Karnataka
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First Year M. Pharm Degree Examination – MAY 2016
Time: Three Hours
Max. Marks: 100 Marks
CHEMICAL & BIOLOGICAL EVALUATION
(Revised Scheme 4)
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Q.P. CODE: 9360
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
- Explain in detail about GLP and WHO certification for export of pharmaceuticals.
- a) Explain calibration of UV-Visible Spectrophotometer and HPLC.
b) Discuss Solid phase micro extraction and biological method validation as per ICH guidelines. (10+10) - Explain microbiological validation with examples and sterility testing methods.
b) Discuss the concept of enzyme immuno assays with example. (10+10)
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SHORT ESSAYS (Answer any FIVE) 5 x 10 = 50 Marks
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- Discuss drug rules of Schedule M and reprocessing and salvaging of returned goods.
- Write in detail principle and procedure involved the biological assay of streptokinase and tuberculin purified protein derivative.
- Give source, chemistry and properties of endotoxins and explain official pyrogen testing methods.
- Discuss Q3B and Q3C ICH guideline.
- Explain cleaning and personnel validation.
- Write on development of drug information profile and microbial assays of antibiotics.
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SHORT NOTES 2 x 5 = 10 Marks
- Write a note on Laboratory Information Management System (LIMS).
- Write a note on test of antimicrobial preservatives.
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This download link is referred from the post: RGUHS M.Pharm Last 10 Years 2011-2021 Previous Question Papers || Rajiv Gandhi University of Health Sciences
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