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
- With the help of a neat sketch explain the layout of the plant for large volume parenteral prepared by terminal sterilization. What different GMP regulations are to be followed in the design of the layout?
- Explain the different techniques for the study of crystal properties and polymorphism with suitable examples
- What different industrial hazards are possible in pharmaceutical industry? Explain the preventive measures
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
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- Explain the significance of pilot plant scale up studies. What are the parameters that influence these studies?
- Explain the significance of human resource development in the pharmaceutical industry
- Explain the forces involved in the tablet compression
- What is your understanding of validation? Briefly describe the different techniques employed in the pharmaceutical industry
- What different statistical methods are employed in the optimization techniques and briefly describe them
- Explain the physico-chemical characteristics of a new drug molecule relevant to different dosage forms
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SHORT NOTES 2 X5 = 10 Marks
- What are the salient features of Trade Related Investment Measures (TRIMS)
- Explain the significance of ISO 9000/Series
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