FACULTY OF PHARMACY
M. Pharmacy (Pharma. Analysis) I-Semester (Supp.) Examination,
August 2018
Subject: Pharmaceutical Validation
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Define qualification and explain the different phases of qualification process of
analytical equipments. 10
Write short notes on re-validation process. 5
2 Write about the following 3x5=15
Validation master plan.
Factory acceptance test and site acceptance test.
Calibration of analytical balance.
3 Describe validation procedure for HVAC system. 10
Write about cleaning-in-place (CIP). 5
4 Describe the method validation parameters for a new analytical method as per ICH
guidelines. 15
5 What is an intellectual property right? Explain about different types of IPR. 8
Discuss the rights and responsibilities of patentee. 7
6 What is a Patent? Explain the procedure for filing an application for patent in
India. 9
What is patent infringement and its scope. 6
7 Explain the procedure involved in qualification and calibration of HPLC 10
Write short note on Digital significance of 21 CFR part II. 5
8 Describe in detail about cleaning validation process. 10
Write about preventive maintenance. 5