Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER II • EXAMINATION SUMMER 2017
Subject Code: 2920202 Date: 31/05/2017
Subject Name: Global Regulatory Requirements
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

Define validation. Describe key principles of equipment validation.
06

Enumerate working area and regulatory guidelines of ANVISA.
05

Enlist contents of IND. Describe process of withdrawal of IND.
05
Q.2

Differentiate calibration and verification. Describe stepwise validation
programme for tablet manufacturing process.
06

Explain the scope of USFDA. Discuss the preparations required for facing USFDA audit.
05

What are clinical trials? How are they organized as a part of drug discovery and development process?
05
Q.3

Describe the basic criteria for new analytical method development. Discuss ruggedness and robustness in context to analytical method validation.
06

What is "Orange Book"? Give brief discussion on therapeutic codes in orange book.
05

Classify NDA. Discuss regulatory requirements for NDA.
05
Q.4

Which are the objectives of computer system validation? Discuss in brief about SAP.
06

Enumerate types of guidelines provided by ICH.
05

What is CTD? What are technical requirements of e-CTD?
05
Q.5

Define FOIA. Which types of information can be obtained as per FOIA?
06

Discuss role and activities carried out by MHRA.
05

Discuss in brief about Enterprise Resource Planning.
05
Q. 6

Discuss TGA's risk management approach.
06

Write a note on IIG.
05

Describe general guidelines of ANDA.
05
Q.7

What are the main functions of WHO? Enlist various WHO guidelines available for pharmaceutical products.
06

Define Drug Master File, Holder, Agent and Application. Give difference between Application and DMFs.
05

Write a note on step wise validation of autoclave.
05