Download GTU B.Pharma 2019 Summer 7th Sem 2270014 Instrumental And Process Validation Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2019 Summer 7th Sem 2270014 Instrumental And Process Validation Previous Question Paper

Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER? 7 EXAMINATION ? SUMMER -2019
Subject Code: 2270014 Date: 20-05-2019
Subject Name: Instrumental and Process Validation
Time: 02:30 PM TO 05:30 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) Describe different types of Process Validation with their advantages.
06

(b) Discuss Validation Master Plan
05

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



Q.2 (a) Describe validation of HPLC system
06

(b) Give objective and principle of equipment qualification. Discuss Design
05
qualification and Installation qualification of equipment.

(c) Discuss steps for Mobile phase selection and optimization in RP- HPLC.
05



Q.3 (a) Explain extraction of Biological Fluid samples.
06

(b) Enlist desirable qualities of critical components of HPLC system. How UPLC
05
is better than HPLC.

(c) Write a note on Laboratory Automation.
05



Q.4 (a) Describe instrumentation of HPTLC.
06

(b) Explain Resolution and Plate Number. What are minimum requirements of
05
these parameters as per ICH guidelines?

(c) Discuss detectors used in GC.
05



Q.5 (a) Write a note on validation of manufacturing process for Sterile Products.
06

(b) Explain LC-MS.
05

(c) How can we validate the Bio-Analytical HPLC method?
05



Q. 6 (a) What are objectives of Cleaning Validation? Explain Cleansing Validation
06
methods used in Pharmaceutical Industry.

(b) Discuss Performance qualification for the validation of Autoclave.
05

(c) Explain Instrumentation of HPLC.
05



Q.7 (a) Explain various steps involved in qualification of Dry Powder Mixer.
06

(b) Discuss scope, types and advantages of Validation.
05

(c) Explain Flow Injection Analysis.
05
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