E!E{laaj?a? Eignejmv Isity of Health Sciences
First Year M. Pharm Degree Examination - Nov 2
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[Time: 3 Hours] [Max. Marks: 100]
Pharmaceutical Technology and Validation
(Revised Scheme 4)
Q.P. CODE: 9362
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
- Explain the effects of Physicochemical and Biopharmaceutical characteristics of a Drug Substance on Preformulation with suitable examples.
- Classify IVIVC (In-Vivo In-Vitro Correlation). Explain in detail.
- Write a note on Water System Validation in a Sterile Manufacturing Unit.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write a note on Stress Testing of Drug Substances.
- Write a note on Post Approval changes of a Bulk Active Chemical.
- Explain the testing of Plastic Containers used for Sterile Dosage Forms.
- Write a note on Role of Validation in GMP.
- Prepare a Master Validation Plan for the Manufacturing of Paracetamol IP 500mg Tablets.
- Explain the Qualification of a Moist Heat Sterilizer.
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SHORT NOTES 2 X 5 = 10 Marks
- Write a note on Accelerated Stability Testing of Drug Substances.
- What is a Commercial Off the Shelf Software? List the Validation Parameters for the same.
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