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9293_2011_2_S252.doc
Rajiv Gandhi University of Health Sciences, Karnataka
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First Year M. Pharm Degree Examination – Nov 2011
[Time: 3 Hours] [Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(RS 2 & RS 3)
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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
- Explain the location, plan and layout requirement for a sterile dosage form manufacturing unit
- Write a note on planning, execution and closing of regulatory audit of a pharmaceutical manufacturing unit
- Differentiate loan license manufacturing and contract manufacturing. Explain the implementation of GMP for these activities
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write a note on personnel hygiene
- Explain the methods and precautions for control of contamination in non sterile dosage forms
- Write a typical purchase specifications and maintenance SOP for HPLC with UV detector
- Explain the salient features of factory Act
- What are batch release documents? Explain each document in detail
- Write a note on cleaning validation
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SHORT NOTES 2 X 5 = 10 Marks
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- Explain reprocessing of non sterile dosage forms with special emphasis on stability
- Write a note on retention
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This download link is referred from the post: RGUHS M.Pharm Last 10 Years 2011-2021 Previous Question Papers || Rajiv Gandhi University of Health Sciences
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