Download RGUHS M.Pharm 2010 May 1st Year 9293 Quality Assurance Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2010 May (Master of Pharmacy) 1st Year 9293 Quality Assurance Previous Question Paper

9293_2008_1_S151
Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination ? May - 2010

[Time: 3 Hours]
[Max. Marks: 100]
QUALITY ASSURANCE
PAPER III








(Revised Scheme 2)

Q.P. CODE : 9293
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions

LONG ESSAY (Answer any TWO)
2 X 20 = 40 Marks
1.
Explain the concept of GLP. Outline the procedure for dealing with recovered materials and
reprocessing.
2.
Write in detail about the layout and good warehousing practices in pharmaceutical industries.
3.
What is patent? What are the procedures to be followed while obtaining a patent? What is
meant by infringement? What are the laws governing the patent?
SHORT ESSAY (Answer any FIVE)
5 X 10 = 50 Marks
4.
Explain in detail about the procedures involved in GMP certification.
5.
Write briefly on:
(a) Recent amendments in Drugs and Cosmetic Act.
(b) Selection of vendors.
6.
Explain the following with reference to a pharmaceutical formulation units:
(a) Master formula record.
(b) Quality audits.
7.
Discuss the role of quality policy and management approach in "Total Quality Management".
8.
Discuss in brief about ISO 9000 series of quality assurance standard.
9.
Write short notes on:
(a) Material management.
(b) Line Clearance.
SHORT NOTES
2 X 5 = 10 Marks
10. Briefly enumerate the recall procedures.
11. Write notes on scrap disposal procedures.
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