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
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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
- a) Method of preparation of SOPs with an example. (10+10)
b) WHO certification regulations for export of Pharmaceuticals. - a) Discuss the concepts, methodology and interpretation of official methods of Pyrogen testing. (10+10)
b) Describe the principle involved in zone of inhibition and zone of exhibition with appropriate example. - a) Principle and procedure involved in biological assay of (i) streptokinase (ii) oxytocin. (12+8)
b) State ICH Q3C guidelines.
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SHORT ESSAYS (Answer any FIVE) 5 x 10 = 50 Marks
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- Describe the methods for biological sample preparation.
- Write briefly about the sterility testing methods.
- Mention the chemical analysis of potable water.
- Write short notes on
i) Development of drug information profiles.--- Content provided by FirstRanker.com ---
ii) Quality audit. - Describe the process of Cleaning validation.
- Describe the procedure in calibration of UV-Visible spectrophotometer.
SHORT NOTES 2 x 5 = 10 Marks
- Application of computers in quality control laboratory.
- Salvaging of returned goods.
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