Download OU M.Pharma Ph.Analysis 1st Sem 2020 6132PCI Pharmaceutical Validation Question Paper

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Code No: 6132/PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmaceutical Analysis) I-Semester (PCI) (Main & Backlog) Examination, January 2020

Subject: Pharmaceutical Validation

Time: 3 Hrs Max. Marks : 75

Note: Answer any five questions. All questions carry equal marks.

1. Explain the following terms. 5+5+5
   1. User requirement specification

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   2. Factory acceptance test
   3. Site acceptance test
2. Write note on the following
   1. Calibration of FTIR. (7)
   2. Cleaning in place (8)

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3. Define IPR. Explain the criteria of patentability of an invention and describe the steps involved in patent application. (1+7+7)
4. Explain the difference between qualification, calibration, validation and explain about instrument qualification. (5+10)
5. Write note on the following.
   1. What are the different types of water used in pharmaceutical industry?
   2. Different steps involved in the calibration of HPLC instrument. (7+8)

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6. 1. Discuss about pharmaceutical water system validation.
   2. Explain the procedure to calibrate wavelength of UV instrument. (10+5)
7. 1. Describe the Method Validation parameters for new Analytical method.

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   2. What is meant by revalidation and when to revalidate? (12+3)
8. Write note on the following
   1. Types of process validation.
   2. Validation master plan. (8+7)

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