GTU B.Pharm 2019 Summer Question Papers || Gujarat Technological University
Seat No.:
Subject Code: 2270014
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Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER- 7 EXAMINATION - SUMMER -2019
Subject Name: Instrumental and Process Validation
Time: 02:30 PM TO 05:30 PM
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Instructions:
- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- 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 |
| Q.2 (a) | Discuss column and column packing material used in GC | 05 |
| (b) | Describe validation of HPLC system | 06 |
| Q.3 (a) | Give objective and principle of equipment qualification. Discuss Design qualification and Installation qualification of equipment. | 05 |
| (b) | Discuss steps for Mobile phase selection and optimization in RP- HPLC. | 05 |
| Q.4 (a) | Explain extraction of Biological Fluid samples. | 06 |
| (b) | Enlist desirable qualities of critical components of HPLC system. How UPLC is better than HPLC. | 05 |
| Q.5 (a) | Write a note on Laboratory Automation. | 05 |
| (b) | Describe instrumentation of HPTLC. | 06 |
| Q.6 (a) | Explain Resolution and Plate Number. What are minimum requirements of these parameters as per ICH guidelines? | 05 |
| (b) | Discuss detectors used in GC. | 05 |
| Q.7 (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 |
| (a) | What are objectives of Cleaning Validation? Explain Cleansing Validation methods used in Pharmaceutical Industry. | 06 |
| (b) | Discuss Performance qualification for the validation of Autoclave. | 05 |
| (c) | Explain Instrumentation of HPLC. | 05 |
| (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 |
Total Marks: 80
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Date: 20-05-2019
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