Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph.- SEMESTER-II • EXAMINATION SUMMER -2018
Subject Code:MPT204T Date: 21/05/2018
Subject Name: Regulatory Requirements for Pharmaceutical Manufacturing
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

Describe principles of QbD as per ICH.
06

Write advantages, limitations and key elements of QbD in detail.
05

Explain QTPP and CQA as per ICH.
05
Q.2

Write objectives of Pharmaceutical development and discuss components of the drug products.
06

Discuss in detail about submission of Pharmaceutical development and related information as per CTD format.
05

Write an overview on "Optimization techniques in Pharmaceutical formulation and processing".
05
Q.3

Discuss in general about Quality Risk Management process.
06

What is Quality with respect to Pharmaceuticals? Write scope and principles of Quality Risk Management.
05

Explain HACCP and FMEA in detail.
05
Q.4

Write scope, objectives and Continual Improvements of the Pharmaceutical Quality Management System as per ICH Q10.
06

Discuss QbD approach as per ICH.
05

Explain in detail about Components and purpose of Experimental Design.
05
Q.5

Discuss QbD control strategy for Immediate Release and Modified Release dosage forms.
06

Explain Risk Assessment of Drug Product manufacturing process for modified release dosage forms.
05

Discuss Management responsibilities in PQM.
05
Q. 6

Write details on PAT Framework PAT Tools
06

Discuss examples of PAT implementation in detail.
05

Explain Risk Assessment of the Tablet compression process variables for Immediate release dosage forms.
05
Q.7

Write a short note on "QbD Implementation An FDA Perspective"
06

Highlight brief review on QRM tools.
05

Explain Implications Benefits of ICH in the Drug Development Cycle.
05