RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Rajiv Gandhi University of Health Sciences
Second Semester M. Pharmacy Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
Pharmaceutical Validation - II
Q.P. CODE: 5162
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- What is Validation? Explain in detail. Write a detailed note on Validation and Calibration of Analytical equipment.
- Explain the Qualification of dissolution apparatus.
- Explain methods to validate Air Handling system for air supply for sterile area.
- Explain the validation procedures for aseptic filling.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write about Validation of Tablet Compression.
- Explain in detail Cleaning Validation.
- Explain the Qualification Process and documentation of Fluid Bed Drier.
- Write in brief Re-Validation Process.
- Differentiate between calibration and validation.
- Write note on calibration preventive maintenance.
- Write note on qualification of dry heat sterilization.
- Write note on scope of validation.
- Explain the qualification of LC-MS.
- Write note on process validation of aerosols.
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