First Semester M. Health Sciences Degree Examination
Time: Three Hours Max. Marks: 75 Marks
Quality Control and Quality Assurance
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Q.P. CODE: 5103
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
- Explain the contents of a Batch Manufacturing Record? How is it developed?
- How are ICH guidelines organized by scope? List the Q series guidelines of ICH?
- Enlist quality control tests for parenterals. Explain any three.
- Compare and control the roles and responsibilities of QA & QC departments.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- List the responsibilities of QAU in a GLP study?
- Explain the concept of FIFO, and its significance.
- Explain the protocol for conduct of non-clinical testing.
- Discuss about drug industry location, design and construction.
- Explain the QC tests prescribed for ophthalmic products?
- Describe quality audit plan and reporting.
- Explain in detail about aseptic process control.
- Explain the CTD Triangle and its modules.
- Explain IPQC, tests mandated for tablet production.
- Describe personal training as per WHO.
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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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