Download OU M.Pharma Ph.Analysis 2nd Sem 2019 13181PCI Quality Controls And Quality Assurance Question Paper

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Code No. 13181/PClI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmaceutical Analysis) ll-Semester (PCI) (Suppl.) Examination, February 2019

Subject: Quality Controls and Quality Assurance

Time: 3 Hrs Max. Marks: 75

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

1. Write a short note on the following
   1. Quality control. (5)

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   2. Quality assurance. (5)
   3. Non clinical testing. (5)
2. Explain the various CPSCEA guidelines for laboratory animal facility. (15)
3. Define IPQC. Explain in detail about various IPQC tests for
   1. Capsules. (8)

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   2. Parenterals. (7)
4. Give a brief note on
   1. Quality audit plan. (5)
   2. Protocols and reports. (5)
   3. Distribution records. (5)

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5. Discuss the Good laboratory practices for a quality control laboratory in detail. (15)
6. 1. Explain the various documents to be maintained by the quality control department. (7)
   2. Explain Master formula and Batch formula records. (8)

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7. Explain various cGMP guidelines according to schedule M.
8. Write a note on
   1. Sanitation of manufacturing premises (5)
   2. Drug product inspection: (5)
   3. Production record review. (5)

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