Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MRA101T Date: 01/01/2019
Subject Name: Good Regulatory Practices
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

Discuss the following terms with respect to 21CFR 210- Fiber, Gang printed labelling, potency, acceptance criteria, actual yield and component.
06

Write a note on Drug product containers and closures as per 21CFR 211.
05

Enlist all the subparts of 21CFR 211.
05
Q.2

Write a note on site master file as per EC GMP.
06

Describe Sampling and Testing as per EC GMP.
05

Write a note on GAMP 5.
05
Q.3

Write a note on Manufacture of Pharmaceutical excipients as per WHO GMP.
06

Describe the animal care facilities as per USFDA GLP for non-clinical laboratory studies.
05

Write a note on Goals of Laboratory Quality audit.
05
Q.4

Describe the principles of GALP.
06

Discuss Controls in 21CFR 11.
05

What is GDP? Discuss Vehicles and Equipment as per GDP.
05
Q.5

Discuss GDP- supply chain integrity as per USP.
06

Write a note on Six Sigma Concept.
05

Discuss the term QbD and its applications.
05
Q. 6

Discuss ICH guidelines on Quality.
06

What is OOS and Change control? Discuss with examples.
05

Write a note on types of Validations and types of Qualifications.
05
Q.7

Discuss Stability testing principles as per GDP.
06

Discuss the requirements for Medical device manufacturing as per Sch M III.
05

Write a note on software evaluation as per ISO.
05