Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination – MAY 2016
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[Time: 3 Hours] [Max. Marks: 100]
PREFORMULATION AND PRODUCTION MANAGEMENT
(RS2 & RS3)
Q.P. CODE: 9282
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
- List-out and explain preliminary evaluation tests required before preformulation studies. Explain preformulation studies.
- Discuss in detail Q1A (R2) stability testing for drug substances.
- Write the primary functions and significance of the pharmaceutical pilot plant and explain in detail about the general considerations of pilot plant design.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Define safety stock. What are its advantages? Give the method of calculation. What is meant by stock out position? Explain the reasons and implications.
- Give the differences between ICH and WHO guideline for stability.
- Write the objectives of material management. Discuss the factors to be considered while selecting material handling equipments.
- What are the various protective measures for keeping machine intact? Give examples. What are the benefits of preventive maintenance?
- What are the two optimization parameters? Explain. What are the various applications of optimization?
- Write the formulation aspects of medicated lozenges
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SHORT NOTES 2 X 5 = 10 Marks
- Write a note on GATT and TRIPS.
- Explain process validation.
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