Download RGUHS M.Pharmacy First Year 2014 November 9362 Pharmaceutical Technology And Validation RS 4 Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M Pharma (Master of Pharmacy) First Year (1st Year) 2014 November 9362 Pharmaceutical Technology And Validation RS 4 Question Paper.

Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - Oct/Nov 2014
[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.
Draw neat, labeled diagrams wherever necessary.

LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
1. Explain the effects of Physicochemical and Biopharmaceutical characteristics of a Drug
Substance on Preformulation with suitable examples.
2. Classify IVIVC (In-Vivo In-Vitro Correlation). Explain in detail.
3. Write a note on Water System Validation in a Sterile Manufacturing Unit.

SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
4. Write a note on Stress Testing of Drug Substances.
5. Write a note on Post Approval changes of a Bulk Active Chemical.
6. Explain the testing of Plastic Containers used for Sterile Dosage Forms.
7. Write a note on Role of Validation in GMP.
8. Prepare a Master Validation Plan for the Manufacturing of Paracetamol IP 500mg Tablets.
9. Explain the Qualification of a Moist Heat Sterilizer.

SHORT NOTES 2 X 5 = 10 Marks
10. Write a note on Accelerated Stability Testing of Drug Substances.
11. What is a Commercial Off the Shelf Software? List the Validation Parameters for the same.

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