First Year M.Pharm Degree Examination – May 2012
[Time: 3 Hours] [Max. Marks: 100]
CHEMICAL AND BIOLOGICAL EVALUATION
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PAPER IV
(RS 2 & RS 3)
Q.P. CODE: 9224
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
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LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Explain 21 CFR- Application of computer in quality control laboratory.
- Elaborate the SOPs for operating pharmaceutical machinery.
- Discuss the planning, design and plant layout of a pharmaceutical industry.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Compare and contrast the pyrogen testing as per I.P., B.P. and U.S.P. methods.
- What are the criteria to constitute salvaging of returned goods and reprocessing?
- Explain the principles and procedure involved in the Biological assay of Rabbies and Plague vaccines.
- How do you calibrate the analytical equipment?
- Write notes on development of drug information profile.
- Write about the sampling techniques.
- Give an account of Sterility testing methodology and how do you interpret?
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SHORT NOTES 2 X 5 = 10 Marks
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- Write notes on biological assay of Chorionic Gonadotrophin.
- Write the properties of bacterial pyrogen and endotoxin.
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