RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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Note: Draw labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Define validation. What are the advantages of qualification? Discuss about validation master plan.
- Explain about calibration of HPLC.
- Discuss in detail about compressed air and Nitrogen in validation of utility system.
- Describe the various phases in drug development and drug approval.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain about calibration of pH meter.
- Explain the qualification of volumetric flask.
- Write a note on loan license.
- Write a note on cleaning in place.
- Discuss about analytical method validation by ICH guidelines.
- Explain about validation of pharmaceutical water system.
- Write a note on NDA review process.
- Illustrate the qualification of dissolution apparatus.
- What are IQ, OQ and PQ? Explain by taking suitable example.
- Describe about site acceptance test.
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