Jaypee Institute of Information Technology (JIIT) 2008 B.E Test 1 : GLP and Instrumentation - Question Paper

JAYPEE UNIVERSITY OF INFORMATION TECHNOLOGY

WAKNAGHAT, SOLAN

TEST * 1 FEB. 2008 SEMESTER IV

Course Name: GLP & Instrumentation    Max Marks : 20

Course Code 07B41BT301    Max Time. Ihr

Course credits: 4

Ail Questions are compulsory

Ql) If a study does not involve animals it is not GLP, at the same time the fact is, GLP does not apply to animal field studies Comment on this paradoxical statement Also, discuss the roleoflACUC and USFDA to justify the above statement. (5)

Q2) Is there any difference between EPA proposed regulations and FDA regulations for GLP? Discuss.    (2)

Q3) List the studies that are conducted in compliance with GLP regulations.    (2)

Q4) Explain the following terms:

i)    QA programming

ii)    SOPS

iii)    Test system    (6)