Tamil Nadu Dr MGR Medical University 2009 M.Pharm QUALITY CONTROL AND QUALITY ASSURANCE - - Question Paper

MARCH -2009
[KU 330] Sub. Code: 2866
M.PHARM. DEGREE exam
(Regulations 2006)
(Candidates admitted from 2006-2007 onwards)
FIRST YEAR
Branch V – PHARMACEUTICAL ANALYSIS
Paper IV – QUALITY CONTROL AND QUALITY ASSURANCE
Q.P. Code : 262866
Time : 3 hours Maximum : 100 marks
ans All ques.
I. Essay ques. : (3 X 20 = 60)
1. elaborate the various kinds of packaging material used in a pharmaceutical industry? Add a note on quality control of secondary packaging materials.
2. provide an account on concept and philosophy of TQM.
3. Write notes on the following:
a) Quality audit of manufacturing process and facility.
b) SOP for membrane filtration.
c) Batch Release Document.
II. Write Short Notes : (8 X five = 40)
1. Write application of computers in quality control laboratory.
2. What is master formula record and write its importance in pharmaceutical industry.
3. When and how pharmaceutical products are recalled from the market?
4. Write a note on regulatory drug analysis.
5. Write the process and importance of patenting.
6. What criterias are considered while locating a pharmaceutical manufacturing facility?
7. What protocols are followed while selecting vendors?
8. Write the salient features of consumer protection act.
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Earning:   Approval pending.