Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
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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
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- Discuss in detail about the concept and evolution of quality control and quality assurance.
- Write a note on USFDA guidelines for drug industry location, design, construction and plant layout.
- Explain briefly about the three tier documentation, policy procedures and work instruction in pharmaceutical industry.
- 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
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- Explain the quality control tests for ophthalmic products.
- Discuss about the processing of intermediates and bulk products.
- Write about the sanitation of manufacturing premises.
- Write the procedure involved in the control on animal house.
- Explain the report preparation and documentation for non clinical laboratory study.
- Write in detail about the quality control test for Containers.
- Explain in brief quality audit plan in Pharmaceutical Industry.
- Write a note on aseptic process control.
- Write the procedure involved in the preparation of master formula record.
- Discuss in brief process deviation and expiry date calculation.
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