GTU B.Pharm 2019 Winter Question Papers || Gujarat Technological University
Seat No.:
Subject Code: 2270015
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Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER- 7 EXAMINATION - WINTER -2019
Subject Name: Quality by Design (QbD) and Process Analytical Technology (PAT)
Time: 10:30AM TO 01:30PM
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Instructions:
- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
| Q. No. | Question | Marks |
|---|---|---|
| Q.1 (a) | Enlist PAT tools and Explain process control tool. | 06 |
| Q.1 (b) | Give brief review on ICH Q9. | 05 |
| Q.1 (c) | Give importance of DoE and risk assessment in formulation development. | 05 |
| Q.2 (a) | Explain requirement of QbD. Discuss the various elements of QbD. | 06 |
| Q.2 (b) | Give your inputs to develop zero defect formulation based on quality point of view. | 05 |
| Q.2 (c) | Give the difference between Classical optimization and statistical design | 05 |
| Q.3 (a) | Write about Current approaches to QbD. | 06 |
| Q.3 (b) | Write a short note on question based review (QbR). | 05 |
| Q.3 (c) | Explain briefly Continual Improvement of Process Performance And Product Quality. | 05 |
| Q.4 (a) | Explain what is quality? Write about relevance of quality with respect to pharmaceuticals. | 06 |
| Q.4 (b) | Explain about the Real time release approach. | 05 |
| Q.4 (c) | How one can improve the quality of product in manufacturing area. | 05 |
| Q.5 (a) | What is design of experiment? Give method and application of optimization of parameters in formulation with example. | 06 |
| Q.5 (b) | Explain in brief CTD. | 05 |
| Q.5 (c) | Discuss in details strategy for implementation of PAT. | 05 |
| Q.6 (a) | Write in detail case study of QbD for one Modified release dosage forms. | 06 |
| Q.6 (b) | Write a note on risk based approach and integrated system approach. | 05 |
| Q.6 (c) | Explain the Failure Mode Effects Analysis (FMEA) | 05 |
| Q.7 (a) | Explain the Hazard Analysis and Critical Control Points (HACCP) | 06 |
| Q.7 (b) | Give the full name of the following terminology: 1.QTPP 2. CMA 3. CQA 4.CPP 5. RLD. | 05 |
| Q.7 (c) | Explain Yate’s method for optimization with example. | 05 |
Date: 28-11-2019
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Total Marks: 80
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