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

Download OU (Osmania University) M.Pharma-Ph.Analysis (Master of Pharmacy) 2nd Semester 2019 13181PCI Quality Controls And Quality Assurance Previous Question Paper

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Code No. 13181/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutical Analysis) II-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
a) Quality control. (5)
b) Quality assurance. (5)
c) Non clinical testing. (5)
2 Explain the varis CPSCEA guidelines for laboratory animal facility. (15)
3 Define IPQC. Explain in detail abt varis IPQC tests for
a) Capsules. (8)
b) Parenterals. (7)
4 Give a brief note on
a) Quality audit plan. (5)
b) Protocols and reports. (5)
c) Distribution records. (5)
5 Discuss the Good laboratory practices for a quality control laboratory in detail. (15)
6 a) Explain the varis documents to be maintained by the quality control
department. (7)
b) Explain Master formula and Batch formula records. (8)
7 Explain varis cGMP guidelines according to schedule M.
8 Write a note on
a) Sanitation of manufacturing premises (5)
b) Drug product inspection. (5)
c) Production record review. (5)
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