Download OU M.Pharma Ph.Analysis 1st Sem 2019 13161 PCI Pharmaceutical Validation Question Paper

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Code No. 13161 / PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmaceutical Analysis) I-Semester (PCI) (Main & Backlog)

Examination, February 2019

Subject: Pharmaceutical Validation

Time: 3 Hrs Max.Marks: 75

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

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1. Explain the following:

   1. Define and explain various Intellectual Property Rights.
   2. Write about the procedure of obtaining an International Patent.

2. Explain the procedure for following:

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   1. Calibration of FTIR
   2. Sampling methods for cleaning validation.

3. List and explain the analytical method validation parameters.

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4. Explain the various types of trademarks and donts in trademarks with suitable examples.

5. Write note on the following:

   1. Define and explain the types of process validation
   2. Different steps involved in the calibration of analytical balance.

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6. 1. What are the different phases of water system validation? (10)
   2. Explain the procedure to calibrate wavelength of UV instrument. (5)
7. 1. What are the different parameters in HVAC to be examined?

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   2. What is meant by revalidation and when to revalidate?

8. Write note on the following:

   1. Electronic records
   2. Validation master plan.

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