RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Examination
[Time: 3 Hours] [Max. Marks: 75]
Pharmaceutical Validation -II
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Q.P. CODE: 5162
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
- What is Validation? Why is it essential? Explain in detail.
- Explain the validation of a Fluidized Bed Dryer.
- Explain in detail the qualification of a HVAC system intended for a sterile manufacturing area.
- With a representative flow chart explain the process validation of a film coated tablet.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- List the factors checked during Design Qualification.
- Differentiate Qualification and Validation.
- Write a note on FAT.
- How will you test the bio-burden of a pharmaceutical sterilization cycle?
- Briefly explain the validation of a product manufacture.
- List different analytical methods used in analytical procedures in cleaning validation.
- Write a note on 21 CFR part 11.
- Write a note on different types of sampling techniques employed in cleaning validation?
- Write a note on validation of air handling systems.
- Explain the process of performing the Qualification of Pharmaceutical water systems.
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