Download OU M.Pharma Ph.Analysis 1st Sem 2018 1152PCI Pharmaceutical Validation Question Paper

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2018 1152PCI Pharmaceutical Validation Previous Question Paper

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Code No. 1152/PCI
M. Pharmacy (Pharma. Analysis) I-Semester (PCI) (Main) Examination, February 2018
Subject: Pharmaceutical Validation
Time: 3 Hrs Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 (a) Define qualification and validation. Write abt design qualification and performance
qualification phases of analytical equipment. 10
(b) Explain the calibration procedure of glassware used in analytical work. 5
2 (a) How do y qualify UV spectrophotometers ? Explain. 10
(b) Write short note on re-validation process. 5
3 Write short notes on
(a) Cleaning validation 8
(b) Pharmaceutical water system validation 7
4 Explain the ICH guidelines for validation of new analytical procedures. 15
5 (a) What is an intellectual property right? Explain abt different types of IPR. 8
(b) Discuss abt violation of IPR and penalties. 7
6 (a) Write abt international patenting requirement procedure. 8
(b) Write abt the role of Intellectual Property in Pharmaceutical Industry. Give few
recent examples. 7
7 (a) Explain the procedure involved in qualification and calibration of FTIR. 10
(b) Write abt factory acceptance test and site acceptance test. 5
8 (a) Explain the steps involved in preparation of validation Master Plan (VMP). 10
(b) Write short note on Digital significance of 21 CFR part II. 5
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This post was last modified on 19 July 2020