Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2014 November (Master of Pharmacy) 1st Year 9362 Pharmaceutical Technology And Validation Revised Scheme 4 Previous 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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