Gujarat Technological University 2010 M.Pharm Regulatory Affairs and New Drug Applications - Question Paper
Seat No. Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharmacy Sem-II Examination July 2010 Subject code: 920204
Subject Name: Regulatory Affairs and New Drug Applications
Date: 07 /07 /2010 Time: 11.00 am - 02.00 pm
Instructions: Total Marks: 80
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 Discuss regulatory requirements for biotechnology derived products. 16
Q.2 What is Drug Master File? Describe types of DMFs in detail. 16
Q.3 What is MSDS? Describe purpose and scope of each section of 16
MSDS.
Q.4 (a) Describe the investigators brochure for IND. 08
(b) Describe specific requirements and contents of an NDA. 08
Q.5 What is the purpose of The pharmacy Act 1948 ? Describe a 16
functions of pharmacy council of India. B. registration of pharmacist.
(a)
(b) (c)
(a)
(b) (c)
Q. 6
08
08
16
Q7
Describe the functions of Central Drug Laboratory. Sale of drugs according to drugs and cosmetic Act.
Write note on any two:
Indian standard Institute.
ASTM
US-FDA
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| Earning: Approval pending. |
