RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
First Semester Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
Pharmaceutical Validation
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Q.P. CODE: 5113
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
- Discuss the history and various phases of Drug development and Drug approvals such as IND, NDA and ANDA.
- Elaborate on URS, FAT, SAT and Requalification of a manufacturing equipment.
- Explain the significance of Qualification for analytical instruments? Describe the qualification of FTIR Spectrometer.
- Write in detail the validation of utility systems in Pharmaceutical Industry with emphasis on HVAC system.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Define Validation and write about Validation Master Plan.
- How is qualification of Disintegration apparatus done?
- Explain the qualification of volumetric flask.
- Write types of sampling methods in Cleaning Validation.
- Write the qualification of Pharmaceutical water system utility.
- How is accuracy and precision determined in Analytical Method Validation?
- Discuss the regulatory aspects of Pharmaceutical drug manufacture.
- Write the salient features of Consumer Protection Act.
- Explain types of Validation in Pharmaceutical Industry.
- Write a note on maintaining status for Calibration, preventive maintenance and change management of manufacturing equipments.
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