Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination – May 2011
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[Time: 3 Hours] [Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(RS 2 & RS 3)
Q.P. CODE: 9293
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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
- Explain 20 quality parameters of ISO 9000.
- Write a note on location, design and layout of a non-sterile pharmaceutical manufacturing unit as per schedule M
- Explain in process quality control (IPQC) tests for solid oral dosage form under the following
- Significance
- Sampling method
- Sample analysis
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
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- Explain label control
- Classify audit. Explain internal audit
- Write the importance of good warehousing practices
- Discuss the implications of environmental protection act on quality of pharmaceuticals
- What are returned goods? Explain the reasons for return of the goods and handling of the same
- Explain the salient features of GLP systems
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SHORT NOTES 2 X 5 = 10 Marks
- What is a patent? Discuss the merits and demerits of patenting
- How "Hatch - Waxman Act" has affected Indian pharmaceutical sector
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