Rajiv Gandhi University of Health Sciences
First Semester M.Pharm Degree Examination
Good Regulatory Practices
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[Time: 3 Hours] [Max. Marks: 75]
Q.P. CODE: 5121
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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- Write in detail about types of validation and validation master plan.
- Write essay on US cGMP part 210 and part 211.
- Write in detail about principles and requirement of GALP.
- Enumerate in detail about GLP inspection process.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- Write a note on out of specification.
- Write briefly about GLP regulations.
- Write a note on validation of water systems.
- Write about documentation process in GDP.
- Write briefly about concept of quality.
- Write a note on six sigma concept.
- Write briefly about cGMP guidelines with respect to medical devices.
- What are audit tool of GLP.
- Write a note on validation master plan.
- Stability testing principles of GDP.
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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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