Download OU M.Pharma Ph.Analysis 1st Sem 2019 13317 PCI Pharmaceutical Validation Question Paper

Time: 3 Hrs                                                                                                                                                                                                                                                        Max.Marks: 75

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Code No. 13317 / PCI

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FACULTY OF PHARMACY

M. Pharmacy (Pharmaceutical Analysis) | — Semester (PCI) (Suppl.) Examination, August 2019

Subject: Pharmaceutical Validation

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

1. Explain the following terms:

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   1. User requirement specification
   2. Factory acceptance test
   3. Site acceptance test.

2. Write note on the following:

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   1. Calibration of volumetric glassware
   2. Cleaning in place

3. Define IPR. Explain the criteria of patentability of an invention and describe the steps involved in patent application.

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4. Explain the difference between qualification, calibration, validation and explain about instrument qualification.

5. Write note on the following:

   1. Different types of waters used in pharmaceutical industry.
   2. Different steps involved in the calibration of HPLC instrument.

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6. 1. Discuss about pharmaceutical water system-validation.
   2. Explain the procedure to calibrate wavelength of UV instrument.
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?

8. Write note on the following:

   1. Types of process validation
   2. Validation master plan

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