Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code:2920202 Date: 19/11/2018
Subject Name: Global Regulatory Requirements
Time:02:30 PM TO 05:30 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

Differentiate between NDA and ANDA. Explain the procedure of approval by flow chart for both.
06

Explain the Para I to IV filing procedure.
05

What is DMF. Explain the types I and II of DMF.
05
Q.2

What is orange book, blue book and green book. What are their importance.
06

What is FOI and IIG.
05

Explain the analytical method validation.
05
Q.3

Explain the prospective, concurrent and retrospective validation in detail.
06

Explain the validation of wet granulation and compression process in tablet manufacturing.
05

Write a note on ERP with its advantage and disadvantages.
05
Q.4

Explain in brief about SUPAC guidelines for immediate release dosage forms.
06

Explain INDA with its objectives.
05

Write a note on Hatch-Waxman Amendments and its impact on pharmaceutical industry
05
Q.5

Discuss role of CDRH, CDER CFSAN in USFDA guidelines
06

Write a note on MHRA.
05

Explain about TGA and its objectives.
05
Q. 6

Define CTD and e-CTD, which are the technical requirements for CTD.
06

Write a note on Post Marketing Surveillance
05

Write a note on ANVISA.
05
Q.7

Explain various phases of drug development and approval
06

Describe evaluation of the stability data as per ICH guidelines.
05

Explain the validation of autoclave.
05