Rajahdaandhi University of Health Sciences
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First Year M. Pharm Degree Examination - NOVEMBER 2015
[Time: 3 Hours]
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Quality Assurance
(Revised Scheme 4)
Q.P. CODE: 9361
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Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
[Max. Marks: 100]
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LONG ESSAY (Answer any TWO)
2 X 20 = 40 Marks
- Classify recalls as per UFDA guidelines and explain each class in detail.
- Explain the importance of Q1, Q2 and Q9 guidelines of ICH.
- Write a note on essential documents to be maintained for the conduct of clinical trials as per ICH E6 guidelines.
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SHORT ESSAY (Answer any FIVE)
5 X 10 = 50 Marks
- Explain the control and reconciliation of packaging materials.
- List the batch release documents. Briefly explain the process of batch release.
- Write a note on principles of scrap management.
- What is annual product quality review and how is it done?
- A batch of tablets failed to meet dissolution specifications. Explain the investigation process and CAPA (Corrective and Preventive Actions) for the same.
- What is the importance of IPR (Intellectual Property Rights) in pharmaceutical sector? Explain the steps involved in filing IPR.
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SHORT NOTES
2 X 5 = 10 Marks
- List the modules of ANDA (Abbreviated New Drug Application) and write one sentence on each.
- What is the focus of ISO 14000 and why is it important in the pharmaceutical sector?
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This download link is referred from the post: RGUHS Pharma-D Last 10 Years 2011-2021 Previous Question Papers || Rajiv Gandhi University of Health Sciences
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