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Health Sciences
First Semester M. Pharmacy Degree Examination
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[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.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- What are the GMP requirements as per schedule M. Explain its scope.
- Discuss about six system inspection model of USFDA.
- How root cause determination and analysis is done? Explain.
- How will you assign and prioritize risk in pharmaceutical development as per ICH Q9.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- How strategic planning and implementation contributes to quality in pharmaceutical industry.
- Describe principles of six sigma.
- Discuss about handling and evaluation of complaints in pharmaceutical industry.
- Enlist and explain attribute control charts.
- Describe process of batch review and batch release.
- Explain the scope of 21 CFR Part 11.
- Elaborate the application of McKinsey’s 7S model.
- How do you think risk review process contributes to improve quality?
- Explain the scope and salient features of NABL accreditation.
- What is OOS? Distinguish OOS from OOT.
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