RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
I » Include diagrams wherever necessary.
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LONG ESSAY (Answer any Three)
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- Discuss the scope and applications of ICH Q8 in pharmaceutical development.
- What are deviations? Explain how CAPA helps prevent deviation in pharmaceutical process.
- Discuss the process of NABL accreditation.
- What are the categories cost of poor quality and discuss methods of optimizing cost of poor quality?
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Differentiate various types of benchmarking.
- What are the benefits of Statistical Process Control and what “causes” do they address?
- What are the principles of TQM?
- Discuss briefly about electronic records and electronic signatures, and its advantages?
- How do you handle customer complaints?
- Explain the concept of FMECA for risk assessment.
- What are OSHAS guidelines?
- How does process variability impact manufacturing? How is it minimized?
- Discuss the significance of benchmarking process.
- Explain change control process in pharmaceutical industry.
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