Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination — May 2013
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[Time: 3 Hours] [Max. Marks: 100]
FORMULATION PRODUCTION MANAGEMENT
PAPER IV
(Revised Scheme 2)
Q.P. CODE : 9254
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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
- What are the salient features and amendments of drugs and cosmetic act pertaining to manufacture and sale of drugs?
- Describe the influence of process patent era and product patent era on IPR environment in Indian pharmaceutical industry.
- Describe in detail regulatory issues involving effluent treatments and waste management.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Discuss salient features of safety measures employed in pharmaceutical industry.
- Explain importance of production planning and forecasting in a pharmaceutical unit.
- Describe techniques of optimization applied in pharmaceutical formulation with examples.
- Discuss application of total quality management and its influence on productivity.
- Discuss the salient features of WHO GMP standards.
- Discuss the scale up techniques for tablets and liquid orals.
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SHORT NOTES 2 X5 = 10 Marks
- Methods of costing of products and cost control.
- Discuss the ICH guidelines with respect to API.
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