First Year M.Pharm Degree Examination – Nov 2011
[Time: 3 Hours] [Max. Marks: 100]
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FORMULATION PRODUCTION MANAGEMENT
PAPER IV
(Revised Scheme 2)
Q.P. CODE: 9254
Your answers should be specific to the questions asked.
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Draw neat labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Discuss the role of pilot plant scale up techniques for various pharmaceutical products.
- Explain the ICH guidelines, with respect to stability testing of API and finished products.
- Discuss various safety aspects including preventive system during pharmaceutical production.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Explain optimization technique for pharmaceutical formulation and processing.
- Explain the importance of forecasting for pharmaceutical products.
- State the procedure to manufacture any Biological product as per D and C act.
- Give the details of materials handling for various pharmaceutical products.
- Give the steps of Effluent treatment procedure used in a pharmaceutical manufacturing unit.
- Give the outline of production, plan and scheduling for pharmaceutical products.
- Different layouts with respect to a pharmaceutical industry.
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SHORT NOTES 2 X 5 = 10 Marks
- Define validation, explain different types of validation. Add a note on its importance.
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