Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2019 13161 PCI Pharmaceutical Validation Previous Question Paper
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Code No. 13161 / PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutical Analysis) I-Semester (PCI) (Main & Backlog)
Examination, February 2019
Subject: Pharmaceutical Validation
Time: 3 Hrs Max.Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Explain the following:
a) Define and explain varis Intellectual Property Rights. 5
b) Write abt procedure of obtaining an International Patent. 10
2 Explain the procedure for following:
a) Calibration of FTIR 5
b) Sampling methods for cleaning validation. 10
3 List t and explain the analytical method validation parameters. 15
4 Explain the varis types of trademarks and don?ts in trademarks with suitable
examples. 10+5
5 Write note on the following:
a) Define and explain the types of process validation 8
b) Different steps involved in the calibration of analytical balance. 7
6 a) What are the different phases of water system validation? 10
b) Explain the procedure to calibrate wavelength of UV instrument. 5
7 a) What are the different parameters in HVAC to be examined? 12
b) What is meant by revalidation and when to revalidate? 3
8 Write note on the following:
a) Electronic records 5
b) Validation master plan. 10
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This post was last modified on 19 July 2020