Download GTU B.Pharma 2020 Winter 7th Sem 2270015 Quality By Design (Qbd) And Process Analytical Technology (Pat) Question Paper

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Seat No.: Enrolment No.

GUJARAT TECHNOLOGICAL UNIVERSITY

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B.Pharm- SEMESTER-VII + EXAMINATION — WINTER -2020
Subject Code: 2270015 Date: 16/01/2021
Subject Name: Quality by Design (QbD) and Process Analytical Technology (PAT)
Time: 10:30AM To 12:30PM Total Marks: 54

Instructions:

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1. Attempt any THREE questions from Q-1 to Q-6.
2. Q.7 is compulsory to attempt.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 (a) What do you mean by QbD. Discuss its advantages and limitations. 06

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(b) Explain in detail various elements of QbD. 05
(c) Write a note on “QTPP” 05

Q.2 (a) Classify the optimization techniques and explain any one. 06
(b) List out the different parts of CTD. Explain any one in detail. 05
(c) Discuss in detail about Question Based Review (QbR). 05

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Q.3 (a) Discuss in detail about concept of optimization and optimization parameters with suitable example. 06
(b) Give the full name of FMEA and explain it in detail. 05
(c) Discuss in brief about “Statistical Designs” 05

Q.4 (a) What is Quality? Write about scope and principles of Quality Risk Management 06
(b) Write a short note on Hazard Analysis and Critical Control Points (HACCP) 05

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(c) Give brief note on Yate’s method for optimization with an example. 05

Q.5 (a) Write the detailed case study of QbD for any one Immediate release dosage forms 06
(b) Explain in detail Total Quality Management. 05
(c) Discuss in brief about continual Improvement of the Pharmaceutical Quality System. 05

Q.6 (a) Explain the QbD for oral unit dosage form dosage forms considering manufacturing process variables, raw materials and desired attributes. 06

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(b) Discuss in detail case study of QbD for any one Modified release dosage forms. 05
(c) Explain in brief with respect to PAT (1) Risk based approach (2) Integrated system approach. 05

Q.7 (a) Give the full name of PAT. Write about its background and scope in detail. 06
OR
(a) Discuss the process control tool for PAT. 06

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OR
(a) How PAT is implemented. Explain it with suitable example. 06