Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: 2270014 Date: 28/11/2018
Subject Name: Instrumental and Process Validation
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Explain validation of manufacturing process for sterile products.
06

Discuss performance qualification for validation of Autoclave.
05

Explain cleansing validation methods used in pharmaceutical formulation industry.
05
Q.2

Describe Validation Master Plan and its content.
06

Describe validation of wet granulation process and powder mixing for tablet manufacturing.
05

Discuss scope, types and advantages of validation.
05
Q.3

What is Process validation? Describe different types of Process validation with their advantages.
06

Write a note on HPTLC.
05

Define the following terms.
Column resolution, ii) Plate number, iii) Plate height, iv) Selectivity factor,
Capacity factor.
05
Q.4

Differentiate HPLC and HPTLC ii) HPLC and GC.
06

What is hyphenated technique? Write note on LC-MS.
05

Enlist the detectors used in GC. Explain FID in detail.
05
Q.5

How many types of biological fluid samples extraction method? Explain in brief about all method.
06

Describe instrumentation for Gas chromatography.
05

Describe flow injection analysis.
05
Q. 6

Describe validation of HPLC system.
06

Enlist detectors used in HPLC. Explain solute property detector.
05

Write note on laboratory automation.
05
Q.7

Describe system suitability parameter and explain its significance in HPLC method development.
06

How we can validate the bio analytical HPLC method?
05

Discuss column and column packing material used in GC.
05