Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. SEMESTER-II • EXAMINATION -SUMMER-2018
Subject Code: MPT203T Date: 18/05/2018
Subject Name: Pharmaceutical Regulatory Affairs
Time: 10:30 am to 1:30 p.m. 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

Differentiate between Drug Master File and Master Formula Record. Write a note on Drug Master Formula Record.
06

Write a short note on batch manufacturing records
05

Discuss objectives and scope of Documentation.
05
Q.2

Write a short note on post marketing surveillance.
06

Write a note on Hutch Waxman Act and Amendments for generic drugs.
05

What is mean by bioequivalence and explain drug product assessment related to BE.
05
Q.3

Define CTD eCTD. Explain modules of CTD.
06

What is CMC? What are the critical elements of CMC? Explain how CMC is specific to product.
05

Explain the concept of ANDA and ANDA review process.
05
Q.4

Differentiate INDA and ANDA. Describe various type of INDA
06

Discuss the phases of investigation in context to IND.
05

Write a note on scale up process for post approval changes with respect to composition and content.
05
Q.5

Explain classification of drugs in NDA. Discuss the guidance documents required to prepare NDAs.
06

Explain the scope of TGA regulations. Discuss the TGA guidelines for OTC product.
05

Define IND CMC IND safety reports IND annual report Institutional review board.
05
Q. 6

Describe evaluation of the stability data as per ICH guidelines.
06

What is Data integrity? What are the purpose and guidelines for Data integrity?
05

Write a note on Investigator Brochure.
05
Q.7

Discuss development of clinical trial protocol.
06

Give an account on FDA guidelines on clinical trials, review and approval of clinical study.
05

Write short note on Code of Federal regulation.
05