Download OU M.Pharma Ph.Analysis 1st Sem 2018 1303PCI Pharmaceutical Validation Question Paper

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 1st Sem 2018 1303PCI Pharmaceutical Validation Previous Question Paper

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Code No. 1303/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharma. Analysis) I-Semester (PCI) (Supp.) Examination,
August 2018
Subject: Pharmaceutical Validation
Time: 3 Hrs Max. M arks: 75
Note: Answer any five questions. All questions carry equal marks.
1 (a) Define qualification and explain the different phases of qualification process of
analytical equipments. 10
(b) Write short notes on re-validation process. 5
2 Write abt the following 3x5=15
(a) Validation master plan.
(b) Factory acceptance test and site acceptance test.
(c) Calibration of analytical balance.
3 (a) Describe validation procedure for HVAC system. 10
(b) Write abt cleaning -in-place (CIP). 5
4 Describe the method validation parameters for a new analytical method as per ICH
guidelines. 15
5 (a) What is an intellectual property right? Explain abt different types of IPR. 8
(b) Discuss the rights and responsibilities of patentee. 7
6 (a) What is a Patent? Explain the procedure for filing an application for patent in
India. 9
(b) What is patent infringement and its scope. 6
7 (a) Explain the procedure involved in qualification and calibration of HPLC 10
(b) Write short note on Digital significance of 21 CFR part II. 5
8 (a) Describe in detail abt cleaning v alidation process. 10
(b) Write abt preventive maintenance. 5
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