Download RGUHS M.Pharm 2014 Nov 1st Year 9293 Quality Assurance Paper IIi Rs 2 And Rs 3 Question Paper

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Rajiv Gandhi University of Health Sciences

First Year M. Pharm Degree Examination — Oct/Nov 2014

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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

1. What is Industrial hygiene? How do organize your formulation unit with special reference to location, maintenance and sanitation.
2. Explain the good warehousing practices with special emphasis on:
   1. Design of material of construction.

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   2. Store management.
3. 1. Explain the techniques adopted in air control and particulate control.
   2. Write in detail about the UAFDA guidelines on GMP.

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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks

4. Discuss the following in detail:
   1. Globalization of drug industries.
   2. Evaluation of complaints.
5. Write the objectives of the following:
   1. Quality audit.

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   2. Industrial hygiene.
6. Write notes on:
   1. Recent amendments in Drugs and Cosmetics Act.
   2. Quality review.

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7. Write the ISO structure and composition of policy development committees in detail.
8. Describe about the In Process Quality Control with respect to non-sterile products.
9. What is patent? What are the procedures to obtain a patent?

SHORT NOTES 2 X5 =10 Marks

10. Briefly enumerate the selection of vendors.

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11. Write notes on scrap disposal procedure.

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