FACULTY OF PHARMACY
M. Pharmacy (Pharma. Analysis) I-Semester (Main) Examination, February 2018
Subject: Pharmaceutical Validation
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Define qualification and validation. Write about design qualification and performance
qualification phases of analytical equipment. 10
Explain the calibration procedure of glassware used in analytical work. 5
2 How do you qualify UV spectrophotometers? Explain. 10
Write short note on re-validation process. 5
3 Write short notes on
Cleaning validation 8
Pharmaceutical water system validation 7
4 Explain the ICH guidelines for validation of new analytical procedures. 15
5 What is an intellectual property right? Explain about different types of IPR. 8
Discuss about violation of IPR and penalties. 7
6 Write about international patenting requirement procedure. 8
Write about the role of Intellectual Property in Pharmaceutical Industry. Give few
recent examples. 7
7 Explain the procedure involved in qualification and calibration of FTIR. 10
Write about factory acceptance test and site acceptance test. 5
8 Explain the steps involved in preparation of validation Master Plan (VMP). 10
Write short note on Digital significance of 21 CFR part II. 5