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

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Code No. 1152/PClI

FACULTY OF PHARMACY

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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. 1. Define qualification and validation. Write about design qualification and performance qualification phases of analytical equipment. 10

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   2. Explain the calibration procedure of glassware used in analytical work. 5
2. 1. How do you qualify UV spectrophotometers? Explain. 10
   2. Write short note on re-validation process. 5

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3. Write short notes on
   1. Cleaning validation 8
   2. Pharmaceutical water system validation 7
4. Explain the ICH guidelines for validation of new analytical procedures. 15
5. 1. What is an intellectual property right? Explain about different types of IPR. 8

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   2. Discuss about violation of IPR and penalties. 7
6. 1. Write about international patenting requirement procedure. 8
   2. Write about the role of Intellectual Property in Pharmaceutical Industry. Give few recent examples. 7

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7. 1. Explain the procedure involved in qualification and calibration of FTIR. 10
   2. Write about factory-acceptance test and site acceptance test. 5
8. 1. Explain the steps involved in preparation of validation Master Plan (VMP). 10
   2. Write short note on Digital significance of 21 CFR part Il

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