Download OU M.Pharma Ph.Analysis 1st Sem 2020 6132PCI Pharmaceutical Validation Question Paper

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2020 6132PCI Pharmaceutical Validation Previous Question Paper

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Code No.6132/PCI
FACULTY OF PHARMACY

M. Pharmacy (Pharmaceutical Analysis) I-Semester (PCI) (Main & Backlog) Examination,
January 2020

Subject: Pharmaceutical Validation
Time: 3 Hrs Max. Marks : 75

Note: Answer any five questions. All questions carry equal marks.

1 Explain the following terms. 5+5+5
(a) User requirement specification
(b) Factory acceptance test
(c) Site acceptance test

2 Write note on the following
(a) Calibration of FTIR. (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) What are the different types of water used in pharmaceutical industry?
(b) Different steps involved in the calibration of HPLC instrument. (7+8)

6 (a) Discuss abt pharmaceutical water system validation.
(b) Explain the procedure to calibrate wavelength of UV instrument. (10+5)

7 (a) Describe the Method Validation parameters for new Analytical method.
(b) What is meant by revalidation and when to revalidate? (12+3)

8 Write note on the following
(a) Types of process validation.
(b) Validation master plan. (8+7)

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