Download OU M.Pharma Ph.Analysis 2nd Sem 2020 6136PCI Quality Control And Quality Assurance Question Paper

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Code No: 6136/PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharma Analysis) II-Semester (PCI) (Suppl.) Examination, January 2020

Subject: Quality Control and Quality Assurance

Time: 3 Hrs Max Marks: 75

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

1. 1. Explain about Quality Control and Quality Assurance. 8

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   2. Write in detail about Total Quality Management. 7
2. 1. Explain the control on environmental pollution. 8
   2. Explain the maintenance of sterile areas. 7

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3. Write in detail about in-process Quality Control (IPQC) testing of Tablets and parenterals. 15
4. 1. Explain the various documents to be maintained by the quality control department. 7
   2. Explain Master formula and Batch formula records. 8
5. Discuss about
   1. Mix-ups and cross contamination. 8

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   2. Aseptic process control 7
6. Discuss the Good laboratory practices for a quality control laboratory in detail. 15
7. Explain the following
   1. Non-clinical testing. 5
   2. Controls on animal house 5

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   3. Report Preparation. 5
8. Explain various quality control tests for Glass as a packaging material. 15

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