Download RGUHS (Rajiv Gandhi University of Health Sciences) M Pharma (Master of Pharmacy) First Year (1st Year) 2011 May 9293 Quality Assurance Paper III Question Paper.
Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination ? May 2011
[Time: 3 Hours] [Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(RS 2 & RS 3)
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 20 quality parameters of ISO 9000.
2. Write a note on location, design and layout of a non ? sterile pharmaceutical manufacturing
unit as per schedule M
3. Explain in process quality control (IPQC) tests for solid oral dosage form under the following
a) Significance
b) Sampling method
c) Sample analysis
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
4. Explain label control
5. Classify audit. Explain internal audit
6. Write the importance of good warehousing practices
7. Discuss the implications of environmental protection act on quality of pharmaceuticals
8. What are returned goods? Explain the reasons for return of the goods and handling of the same
9. Explain the salient features of GLP systems
SHORT NOTES 2 X 5 = 10 Marks
10. What is a patent? Discuss the merits and demerits of patenting
11. How ?Hatch ? Waxman Act? has affected Indian pharmaceutical sector
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This post was last modified on 20 December 2019