University of Health Sciences
First Semester Degree Examination
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[Time: 3 Hours] [Max. Marks: 75]
Quality Control and Quality Assurance
Q.P. CODE: 5103
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Write a note on CPCSEA guidelines.
- Discuss in detail cGMP guidelines according to CDER USFDA.
- List out the Quality control tests for parenterals according to Indian pharmacopoeia. Explain sterility testing methods.
- Write a note on Electronic Common Technical Documentation (eCTD).
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- What are the objectives of GMP?
- Distinguish between Quality control and quality assurance department.
- Write a note on Good Warehousing Practice.
- Explain the quality control test for Ophthalmic products.
- Discuss the significance of In process quality control Tests.
- Explain the procedure to maintain, retention and retrieval of Master Formula Record.
- Distinguish between contamination, cross contamination and Mix ups.
- How expiry date calculation is done as per ICH guidelines?
- Discuss reprocessing and recovery procedures in formulation of dosage forms.
- Write a note on concepts of trade marks.
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