Rajiv Gandhi University of Health Sciences
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First Year M. Pharm Degree Examination - Oct 2014
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[Time: 3 Hours] [Max. Marks: 100]CHEMICAL AND BIOLOGICAL EVALUATION
PAPER IV
(Revised Scheme 2)
Q.P. CODE : 9224
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Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Write a note on:
a) Vendor validation--- Content provided by FirstRanker.com ---
b) Handling of returned pharmaceutical products - Explain the principle and procedure in the bioassay of Heparin sodium and Typhus vaccine as per IP 1996.
- a) Explain the principle and procedure in the bioassay of Tuberculin PPD as per IP 1996.
b) Explain the calibration of dissolution and disintegration apparatus.
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
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- Explain the applications, advantages and disadvantages of computers in QC lab.
- Why personnel validation is important? Explain the steps in personnel validation.
- Why calibration of volumetric apparatus is necessary? Write the important steps in calibration of volumetric apparatus by taking suitable examples.
- Write a note on SOP for monograph analysis.
- What are the responsibilities and duties of quality control personnel?
- How do you check the effectiveness of the antimicrobial preservatives Thiomersal and Benzoic acid?
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SHORT NOTES 2 X 5 = 10 Marks
- Explain in brief the sterility testing procedure in various pharmaceutical preparations as per IP 1996.
- Explain the various analytical standards of water for injection as per IP 1996 in brief.
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