Download OU M.Pharma Ph.Analysis 2nd Sem 2019 13337PCI Quality Control And Quality Assurance Question Paper

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Code No: 13337/PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharma Analysis) II- Semester (PCI) (Main) Examination, Aug. 2019

Subject: Quality Control and Quality Assurance

Time: 3 Hrs Max Marks: 75

Note: Answer Any Five Questions. ALL Questions carry Equal Marks.

1. Write a detailed note on requirements and guidelines of GMP (Schedule M) in Pharma industries?

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   (15 Marks)

2. Write brief notes on:

   1. Good warehousing practice (7 Marks)
   2. Pharmaceutical inspection convention (8 Marks)

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3. Describe the quality control test for containers, closures and secondary packing materials?

   (15 Marks)

4. 1. Write a short note on good documentation practice guidelines. (6 Marks)

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   2. What are the different types of audits? Explain in detail audit methods and techniques involved in it. (9 Marks)

5. Describe the guidelines of CPCSEA

   (15 Marks)

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6. 1. Explain the quality control test for ointments according to IP (8 Marks)
   2. Release of finished product. (7 Marks)

7. Write brief notes on following:

   1. Change control (7 Marks)

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   2. SOP (8 Marks)

8. Describe sources of contamination and methods of contamination control?

   (15 Marks)

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