Download RGUHS M.Pharm 1st Year 2020 5102 5102 Quality Management System Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 1st Year (First Semester) 2020 5102 5102 Quality Management System Previous Question Paper

Rajiv Gandhi University of Health Sciences, Karnataka
First Semester M. Pharm Degree Examination - 20-Jan-2020
[Time: 3 Hours]
[Max. Marks: 75]
QUALITY MANAGEMENT SYSTEM
Q.P. CODE: 5102
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
Discuss the scope and applications of ICH Q8 in pharmaceutical development.
2.
What are deviations? Explain how CAPA helps prevent deviation in pharmaceutical process.
3.
Discuss the process of NABL accreditation.
4.
What are the categories cost of poor quality and discuss methods of optimizing cost of poor
quality?
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Differentiate various types of benchmarking.
6.
What are the benefits of Statistical Process Control and what `'causes'' do they address?
7.
What are the principles of TQM?
8.
Discuss briefly about electronic records and electronic signatures, and its advantages?
9.
How do you handle customer complaints?
10. Explain the concept of FMECA for risk assessment.
11. What are OSHAS guidelines?
12. How does process variability impact manufacturing? How is it minimized?
13. Discuss the significance of benchmarking process.
14. Explain change control process in pharmaceutical industry.
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