Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm SEMESTER VII • EXAMINATION WINTER-2016
Subject Code: 2270015 Date: 29/11/2016
Subject Name: Quality by Design and Process Analytical Technology
Time: 10.30 AM to 01.30 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

Explain in detail CTD.
06

Write history, current approach and limitations of QbD.
05

Why QbD is required? Write advantages and elements of QbD.
05
Q.2

Discuss General Quality Risk Management Process.
06

Write full forms of Terminology: QTPP, CMA, CQA, CPP and RLD.
05

Write in brief about Design space and design of experiments.
05
Q.3

Discuss classical optimization and optimization parameters.
06

Explain in detail Question Based Review (QbR).
05

Explain the concept of optimization and application of optimization techniques.
05
Q.4

Short note on Statistical designs.
06

What is quality? Explain relevance of quality with respect to pharmaceuticals.
05

Write scope and principles of Quality Risk Management.
05
Q.5

Give detailed case study of QbD for any one Immediate release dosage forms.
06

QbD for vaginal dosage forms considering manufacturing process variables, raw materials and desired attributes.
05

Write a note on Total Quality Management (TQM).
05
Q. 6

Give detailed case study of QbD for any one Modified release dosage forms.
06

Write on Continual Improvement of Process Performance And
Product Quality.
05

Introduction, Scope and background of Process Analytical Technology.
05
Q.7

QbD for Topical dosage forms considering manufacturing process variables, raw materials and desired attributes.
06

Write on Process Analytical Technology Framework and Tools.
05

Discuss Process Analytical Technology(PAT) in pharmaceutical development and its application.
05