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Rajiv Gandhi University of Health Sciences

First Year M. Pharm Degree Examination - NOVEMBER 2015

[Time: 3 Hours]                                                                      [Max. Marks: 100]

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Pharmaceutical Technology and Validation

(Revised Scheme 4)                                                                     Q.P. CODE: 9362

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

1. Write about various techniques involved in enhancing the solubility of an API. Write in detail about enhancement of solubilization by different methods.
2. Explain in vivo- in vitro correlation in detail.

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3. Define Validation. Classify validation. Explain validation of HVAC system.

SHORT ESSAY (Answer any FIVE)                                                                    5 X 10 = 50 Marks

4. Write a note on force degradation.
5. Discuss similarity and dissimilarity factors.
6. Discuss primary and secondary packaging.
7. Explain about validation of tablet punching machine.

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8. Write about validation of fluid bed drier and mixer.
9. Discuss on different types of containers and closures used in pharmaceuticals.

SHORT NOTES                                                                                                                                                                       2 X 5 = 10 Marks

10. Explain validation of electronic record.
11. What is BCS Classification? Explain.

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