Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination — May 2013
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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
- Give a brief account on complaints and recall procedures of pharmaceutical products
- Discuss about the development of standard operating procedure for the compression and coating of tablets
- Describe in detail about the procedure for the disposal of waste for pharmaceutical industry and outline the methods of record maintenances for this purpose
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write briefly on:
- ISO 9000
- USFDA guidelines for the establishment of non clinical testing laboratories
- Explain in detail about the procedures involved in the GMP certification
- Write short notes on
- Line Clearance
- Master formula
- Discuss the following:
- Material management
- GLP protocols on clinical testing
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- What are the materials to be sampled in pharmaceutical industry? Discuss in detail
- What is patent? What are procedures to be followed to obtain a patent?
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SHORT NOTES 2 X5 =10 Marks
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- Briefly enumerate the evaluation of complaints
- Write notes on handling of return goods
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