Download OU M.Pharma Ph.Analysis 1st Sem 2018 1303PCI Pharmaceutical Validation Question Paper

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Code No. 1303/PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharma. Analysis) I-Semester (PCI) (Supp.) Examination, August 2018

Subject: Pharmaceutical Validation

Time: 3 Hrs Max. Marks: 75

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

1. (a) Define qualification and explain the different phases of qualification process of analytical equipments. 10
   

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   (b) Write short notes on re-validation process. 5
2. Write about the following 3x5=15
   (a) Validation master plan.
   (b) Factory acceptance test and site acceptance test.
   (c) Calibration of analytical balance.

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3. (a) Describe validation procedure for HVAC system. 10
   (b) Write about cleaning -in-place (CIP). 5
4. Describe the method validation parameters for a new analytical method as per ICH guidelines. 15
5. (a) What is an intellectual property right? Explain about different types of IPR. 8
   (b) Discuss the rights and responsibilities of patentee. 7

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6. (a) What is a Patent? Explain the procedure for filing an application for patent in India. 9
   (b) What is patent infringement and its scope. 6
7. (a) Explain the procedure involved in qualification and calibration of HPLC 10
   (b) Write short note on Digital significance of 21 CFR part II. 5
8. (a) Describe in detail about cleaning validation process. 10
   

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   (b) Write about preventive maintenance. 5