Download RGUHS M.Pharm 2nd Year 2020 5142 Scale Up And Technology Transfer Question Paper

LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks

1. Explain the pilot plant design in detail. FirstRanker.com
2. Explain equipment qualifications of autoclave.

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3. Define validation. Explain the process validation of liquid filling sealing.
4. Define industrial hazards. Explain different types of fire extinguishers.

SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks

5. Define technology transfer. Enlist the problems encountered during technology transfer.
6. Describe Validation Master Plan.

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7. Explain the importance of installation and operational qualification.
8. Describe the process of validation of mixing.
9. Explain the importance of vendor qualification.
10. Write a note on chemical hazards in pharmaceutical industry.
11. Describe equipment qualification of rotary tablet compression machine.

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12. Describe the protocol of cleaning validation.
13. Explain with a neat diagram of a pilot plant layout of parenteral dosage form.
14. Describe prospective validation and concurrent validation.