Rajiv Gandhi University of Health Sciences
First Year M. Pharmacy Degree Examination
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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. Answer any ten questions.
LONG ESSAY (Answer any TEN) 10 X 10 = 100 Marks
- Discuss the concept of TQM. Add a note on ICH-E6 guidelines.
- Discuss the concept of QSEM series of ICH guidelines.
- Discuss the responsibilities, training requirements for personnel working in sterile manufacturing area.
- Discuss cGMP guidelines for construction, maintenance and sanitation of Pharmaceutical unit.
- Write a master formula for sodium chloride 0.9% injection.
- Write standard operating procedure (SOP) for cleaning and disinfection of sterile manufacturing area.
- Discuss in detail Good warehousing practices and cold chain management.
- Describe the procedure for handling of returned goods reprocessing.
- Write an explanatory note on European guidelines for contract manufacturing.
- Write introductory note on scope, importance and concept of IPR.
- Explain the in-process quality controls for non sterile dosage forms.
- Explain the scope and importance of intellectual property rights.
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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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