Rajiv Gandhi University of Health Sciences
First Semester Master Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
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Quality Management System
Q.P. CODE: 5102
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
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- Explain in detail the significance of mission and vision statements in an industry.
- Explain the concept of pharmaceutical quality management as per ICH Q10.
- Explain the management of risk as per ICH Q9 guidelines.
- With the help of a flow chart, explain the benchmarking of a quality process.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- Write a note on cost optimizing strategies.
- Explain the features of NABL accreditation.
- Explain the scope of ISO 9001:2015
- What is annual product reviews? Why is it compiled?
- Explain returns and recalls.
- What are OOS and OOT? Explain.
- What are control charts? Give their applications.
- Explain how SPC helps in measuring quality.
- Explain the stability testing condition for a new drug as per ICH guidelines.
- Explain briefly the role of HACCP in risk management.
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This download link is referred from the post: RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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