Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 June (Master of Pharmacy) 1st Year (First Year) 2nd Year 5151 Quality Control And Quality Assurance II Previous Question Paper

Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination - JUNE 2019
[Time: 3 Hours]
[Max. Marks: 75]
Quality Control and Quality Assurance -II
Q.P. CODE: 5151
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
Discuss in detail about the concept and evolution of quality control and quality
assurance.
2.
Write a note on USFDA guidelines for drug industry location, design, construction and
plant layout.
3.
Explain briefly about the three tier documentation, policy procedures and work
instruction in pharmaceutical industry.
4.
Describe the measurements of patent rights and patent enforcement according to
patent regime and IPR.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Explain the quality control tests for ophthalmic products.
6.
Discuss about the processing of intermediates and bulk products.
7.
Write about the sanitation of manufacturing premises.
8.
Write the procedure involved in the control on animal house.
9.
Explain the report preparation and documentation for non clinical laboratory study.
10.
Write in detail about the quality control test for Containers.
11.
Explain in brief quality audit plan in Pharmaceutical Industry.
12.
Write a note on aseptic process control.
13.
Write the procedure involved in the preparation of master formula record.
14.
Discuss in brief process deviation and expiry date calculation.
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