Download GTU B.Pharma 2020 Winter 7th Sem 2270014 Instrumental And Process Validation Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2020 Winter 7th Sem 2270014 Instrumental And Process Validation Previous Question Paper

Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER? VII ? EXAMINATION ? WINTER -2020
Subject Code: 2270014
Date: 16/01/2021
Subject Name: Instrumental and Process Validation
Time: 10:30AM To 12:30PM
Total Marks: 54
Instructions:


1. Attempt any THREE questions from Q-1 to Q-6.
2. Q.7 is compulsory to attempt.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 (a) Discuss methods of precipitation of protein from biological fluid
06

(b) Describe Operational qualification and Performance qualification for Autoclave 05

(c) What are the types of automated analytical systems
05



Q.2 (a) Discuss steps for mobile phase optimization in HPLC
06

(b) What is hyphenated technique? write note on LC-MS.
05

(c) Explain different types of columns use in GC
05



Q.3 (a) Discuss scope, types and advantages of validation
06

(b) Give steps for validation of Fluidized Bed Drier.
05

(c) Explain briefly validation master plan
05



Q.4 (a) Discuss Column resolution, Selectivity factor and Capacity factor in Liquid
06
chromatography.

(b) Describe validation of HPLC system.
05

(c) Explain injector and guard column in HPLC.
05



Q.5 (a) Discuss Design qualification and Installation qualification of equipment.
06

(b) Explain validation of Tablet manufacturing process.
05

(c) What are objectives and stages of cleaning validation?
05



Q. 6 (a) Enlist detectors used in GC. Discuss any two.
06

(b) Discuss derivatization in GC
05

(c) Discuss steps involved in qualification of Dry powder Mixer
05



Q.7 (a) Write a note on HPTLC.
06
OR

(a) Discuss troubleshooting in LC/MS
06
OR

(a) Describe selection of detector in HPLC
06
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