Rajiv Gandhi University of Health Sciences
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First Year M. Pharm Degree Examination - October 2015
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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.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Discuss in detail the various aspects of quality control laboratory responsibilities and briefly deal on controls on animal house.
- Elucidate in detail the concepts of TQM, philosophy of GLP and ISO 9000.
- What is SOPs? Write SOPs for any operating pharmaceutical machinery used in manufacturing of sterile dosage form. Add a note on Quality audits of manufacturing facilities.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Discuss the Drugs and Cosmetics Act and other relevant rules.
- Write the importance and various aspects of Environmental Protection Act and Consumer Protection Act.
- Write the practice for selection, purchase and maintenance of raw materials and add a note on selection of vendors.
- Discuss the various aspects of In-process quality controls for non-sterile solid dosage form.
- Describe the procedures for waste and scrap disposal. Comment on the records to be maintained.
- Write the methodology employed for finished product release.
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SHORT NOTES 2 X5 = 10 Marks
- Loan license and contract manufacture
- Regulatory drug analysis
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