Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2014 November (Master of Pharmacy) 1st Year 9293 Quality Assurance Paper IIi Rs 2 And Rs 3 Previous Question Paper

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Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination ? Oct/Nov 2014
[Time: 3 Hours]
[Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(RS 2 & RS 3)
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
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:
(a) Design of material of construction.
(b) Store management.
3.
(a) Explain the techniques adopted in air control and particulate control.
(b) Write in detail about the UAFDA guidelines on GMP.
SHORT ESSAY (Answer any FIVE)
5 X 10 = 50 Marks
4.
Discuss the following in detail:
(a) Globalization of drug industries.
(b) Evaluation of complaints.
5.
Write the objectives of the following:
(a) Quality audit.
(b) Industrial hygiene.
6.
Write notes on:
(a) Recent amendments in Drugs and Cosmetics Act.
(b) Quality review.
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 X 5 = 10 Marks
10.
Briefly enumerate the selection of vendors.
11.
Write notes on scrap disposal procedure.
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