Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 January (Master of Pharmacy) 1st Year (First Year) 2nd Year 5162 Pharmaceutical Validation II Previous Question Paper

Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination ? JAN-2019
[Time: 3 Hours]
[Max. Marks: 75]
Pharmaceutical Validation -II
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
1.
What is Validation? Why is it essential? Explain in detail.
2.
Explain the validation of a Fluidized Bed Dryer.
3.
Explain in detail the qualification of a HVAC system intended for a sterile
manufacturing area.
4.
With a representative flow chart explain the process validation of a film coated tablet.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
List the factors checked during Design Qualification.
6.
Differentiate Qualification and Validation.
7.
Write a note on FAT.
8.
How will you test the bio-burden of a pharmaceutical sterilization cycle?
9.
Briefly explain the validation of a product manufacture.
10.
List different analytical methods used in analytical procedures in cleaning validation.
11.
Write a note on 21 CFR part 11.
12.
Write a note on different types of sampling techniques employed in cleaning
validation?
13.
Write a note on validation of air handling systems.
14.
Explain the process of performing the Qualification of Pharmaceutical water systems.
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