Rajiv Gandhi University of Health Sciences, Karnataka
First Year M. Pharm Degree Examination — NOV 2016
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Time: Three Hours Max. Marks: 100 Marks
QUALITY ASSURANCE
(Revised Scheme 4)
Q.P. CODE: 9361
Your answers should be specific to the questions asked.
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Draw neat labeled diagrams wherever necessary
LONG ESSAYS (Answer any Two) 2 x 20 = 40 Marks
- Write Standard Operating Procedures (SOP) for cleaning, filling, drying and compression.
- Write a note on location, design and lay-out of a non-sterile pharmaceutical unit as per schedule M.
- What is QSEM? Write in detail with special emphasis on Q series guidelines.
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SHORT ESSAYS (Answer any FIVE) 5 x 10 = 50 Marks
- Write in details the quality control of packaging materials used in pharmaceutical unit.
- Write a note on distribution of records used in pharmaceutical industry.
- A batch of tablets failed for dissolution specifications. Explain investigation process and CAPA.
- Describe preventive maintenance protocol for equipments used in pharmaceutical industry.
- Write about quality review of finished product.
- Explain BA BE studies (bioavailability, and bioequivalence).
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SHORT NOTES 2 x5 = 10 Marks
- Describe the basic concepts of IND and NDA.
- Explain briefly preventive maintenance protocol for equipments.
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This download link is referred from the post: RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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