Download GTU B.Pharma 2019 Winter 7th Sem 2270015 Quality by Design (QbD) and Process Analytical Technology (PAT) Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2019 Winter 7th Sem 2270015 Quality by Design (QbD) and Process Analytical Technology (PAT) Previous Question Paper

Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER? 7 EXAMINATION ? WINTER -2019
Subject Code: 2270015 Date: 28-11-2019
Subject Name: Quality by Design (QbD) and Process Analytical Technology (PAT)
Time: 10:30AM TO 01:30PM
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) Enlist PAT tools and Explain process control tool.
06

(b) Give brief review on ICH Q9.
05

(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

(b) Give your inputs to develop zero defect formulation based on quality point of
05
view.

(c) Give the difference between Classical optimization and statistical design
05



Q.3 (a) Write about Current approaches to QbD.
06

(b) Write a short note on question based review (QbR).
05

(c) Explain briefly Continual Improvement of Process Performance And
05
Product Quality.



Q.4 (a) Explain what is quality? Write about relevance of quality with respect to
06
pharmaceuticals.

(b) Explain about the Real time release approach.
05

(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
06
parameters in formulation with example.

(b) Explain in brief CTD.
05

(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

(b) Write a note on risk based approach and integrated system approach.
05

(c) Explain the Failure Mode Effects Analysis (FMEA)
05



Q.7 (a) Explain the Hazard Analysis and Critical Control Points (HACCP)
06

(b) Give the full name of the following terminology: 1.QTPP 2. CMA 3. CQA
05
4. CPP 5. RLD.

(c) Explain Yate's method for optimization with example.
05
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