FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutical Analysis) I-Semester (Main Backlog)
Examination, February 2019
Subject: Pharmaceutical Validation
Time: 3 Hours Max.Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Explain the following:
Define and explain various Intellectual Property Rights. 5
Write about procedure of obtaining an International Patent. 10
2 Explain the procedure for following:
Calibration of FTIR 5
Sampling methods for cleaning validation. 10
3 List out and explain the analytical method validation parameters. 15
4 Explain the various types of trademarks and don'ts in trademarks with suitable
examples. 10+5
5 Write note on the following:
Define and explain the types of process validation 8
Different steps involved in the calibration of analytical balance. 7
6 What are the different phases of water system validation? 10
Explain the procedure to calibrate wavelength of UV instrument. 5
7 What are the different parameters in HVAC to be examined? 12
What is meant by revalidation and when to revalidate? 3
8 Write note on the following:
Electronic records 5
Validation master plan. 10