Download RGUHS M.Pharm 2014 Nov 1st Year 9360 Chemical And Biological Evaluation Revised Scheme 4 Question Paper

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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

CHEMICAL & BIOLOGICAL EVALUATION

(Revised Scheme 4)

Q.P. CODE: 9360

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

1. a) Method of preparation of SOPs with an example.
   b) WHO certification regulations for export of Pharmaceuticals. (10+10)
2. a) Discuss the concepts, methodology and interpretation of official methods of Pyrogen testing.
   

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   b) Describe the principle involved in zone of inhibition and zone of exhibition with appropriate example. (10+10)
3. a) Principle and procedure involved in biological assay of (i) streptokinase (ii) oxytocin.
   b) State ICH Q3C guidelines. (12+8)

SHORT ESSAYS (Answer any FIVE) 5 x 10 = 50 Marks

4. Describe the methods for biological sample preparation.

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5. Write briefly about the sterility testing methods.
6. Mention the chemical analysis of potable water.
7. Write short notes on:
   i) Development of drug information profiles.
   ii) Quality audit.

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8. Describe the process of Cleaning validation.
9. Describe the procedure involved in calibration of UV-Visible spectrophotometer.

SHORT NOTES 2 x 5 = 10 Marks

10. Application of computers in quality control laboratory.
11. Salvaging of returned goods.

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