[Max. Marks: 50 Marks]
Faculty : Pharmacy
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Subject : Quality Assurance
PAPER ? II
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Q.P. CODE: P007Your answers should be specific to the Questions asked.
Answer All The Questions
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10 X 05 = 50 Marks
1.
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Write a note on total quality management with pharmaceutical manufacturing perspective.2.
What are statistical control charts? What are the various types of the same? Explain any one
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statistical control chart.3.
Write a note on Pharmaceutical Inspection Convention.
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4.
How Indian Pharmacopoeia 2014 is organized? Explain in detail.
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5.Explain the latest developments in drug registration as per CDSCO.
6.
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Write a note on water pollution by pharmaceutical industry.
7.
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What are the types of fire extinguishers? Explain the principle of working of any two.8.
Write the installation and performance qualification of a HPLC to be installed in a research
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laboratory.9.
What is an external audit? How is it different from internal and regulatory audits?
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10.
Write a note on form fill seal technology for large volume parenteral.
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* * * * *Document Outline
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