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Health Sciences
First Semester M. Pharmacy Degree Examination
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[Time: 3 Hours] [Max. Marks: 75]
Pharmaceutical Validation
Q.P. CODE: 5113
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
- Define validation? Discuss about validation process and validation master plan.
- Discuss briefly about Design qualification? Describe the qualification of FTIR.
- Explain validation of HVAC system, pharmaceutical water system.
- Describe the various phases of drug development and drug approval.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain about qualification of manufacturing equipments.
- Discuss about the qualification of beakers and burette.
- Discuss about requirements of new IND.
- Write a brief note on validation of utility system.
- Discuss about ICH guidelines regarding validation of analytical method.
- Explain about cleaning validation.
- Discuss about regulatory aspects Loan License auditing.
- Explain the qualification of U.V-Visible Spectrophotometer apparatus.
- Write calibration procedure for HPTLC.
- Discuss about site acceptance test.
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