Download OU M.Pharma Ph.Analysis 1st Sem 2019 13317 PCI Pharmaceutical Validation Question Paper

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2019 13317 PCI Pharmaceutical Validation Previous Question Paper

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Code No. 13317 / PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutical Analysis) I ? Semester (PCI) (Suppl.) Examination,
August 2019
Subject: Pharmaceutical Validation
Time: 3 Hrs Max.Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Explain the following terms:
a) User requirement specification 5
b) Factory acceptance test 5
c) Site acceptance test. 5
2 Write note on the following:
a) Calibration of volumetric glassware 7
b) Cleaning in place 8
3 Define IPR. Explain the criteria of patentability of an invention and describe the steps
involved in patent application. 1+7+7
4 Explain the difference between qualification, calibration, validation and explain abt
instrument qualification. 5+10
5 Write note on the following:
a) Different types of waters used in pharmaceutical industry. 7
b) Different steps involved in the calibration of HPLC instrument. 8
6 a) Discuss abt pharmaceutical water system validation. 10
b) Explain the procedure to calibrate wavelength of UV instrument. 5
7 a) Describe the method validation parameters for new analytical method. 12
b) What is meant by revalidation and when to revalidate? 3
8 Write note on the following:
a) Types of process validation 8
b) Validation master plan. 7
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