Rajiv Gandhi University of Health Sciences
First Semester M. Pharmacy Degree Examination
Time: Three Hours Max. Marks: 75 Marks
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Quality Control and Quality Assurance
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
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- Discuss the cGMP guidelines as per schedule M, of the Drugs and Cosmetics Act.
- Explain functions of quality control and quality assurance, in a pharmaceutical manufacturing setup.
- Enlist quality control tests for Hard Gelatin Capsules. Explain any four.
- What is Master batch record? Explain its contents and its regulatory significance.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- List the contents of the protocol intended for a non clinical study?
- How will you ensure change control in pharmaceutical production?
- Explain the principles of Good Warehousing Practice.
- With a diagram explain the layout of tablet manufacturing unit.
- What are purchase specifications? How it is related to maintenance of stores?
- Describe quality control tests for suppositories, as mandated by IP.
- Summarize contents of Common Technical documentation?
- Describe checklist of quality audit report.
- How will you handle materials recovered from the market after a product recall?
- List the elements of IPR applicable to pharmaceuticals.
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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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