Download GTU B.Pharma 2018 Winter 7th Sem 2270014 Instrumental And Process Validation Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2018 Winter 7th Sem 2270014 Instrumental And Process Validation Previous Question Paper

Seat No.: ________ Enrolment No.______________

GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM ? SEMESTER ? 7- 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 (a) Explain validation of manufacturing process for sterile products.
06

(b) Discuss performance qualification for validation of Autoclave.
05

(c) Explain cleansing validation methods used in pharmaceutical formulation
05
industry.



Q.2 (a) Describe Validation Master Plan and its content.
06

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

(c) Discuss scope, types and advantages of validation.
05



Q.3 (a) What is Process validation? Describe different types of Process validation with
06
their advantages.

(b) Write a note on HPTLC.
05

(c) Define the following terms.
05
i) Column resolution, ii) Plate number, iii) Plate height, iv) Selectivity factor,
v) Capacity factor.



Q.4 (a) Differentiate i) HPLC and HPTLC ii) HPLC and GC.
06

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

(c) Enlist the detectors used in GC. Explain FID in detail.
05



Q.5 (a) How many types of biological fluid samples extraction method? Explain in
06
brief about all method.

(b) Describe instrumentation for Gas chromatography.
05

(c) Describe flow injection analysis.
05



Q. 6 (a) Describe validation of HPLC system.
06

(b) Enlist detectors used in HPLC. Explain solute property detector.
05

(c) Write note on laboratory automation.
05



Q.7 (a) Describe system suitability parameter and explain its significance in HPLC
06
method development.

(b) How we can validate the bio analytical HPLC method?
05

(c) Discuss column and column packing material used in GC.
05
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