Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - VIJAY 2015
[Time: 3 Hours] [Max. Marks: 100]
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Quality Assurance
(Revised Scheme 4)
Q.P. CODE: 9361
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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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.
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
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- 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 X5 = 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 for pharmaceutical sector?
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