RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
First Semester M. Pharmacy Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
Product Development and Technology Transfer
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Q.P. CODE: 5104
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
- Define Solubility. Discuss different methods to improve the solubility.
- What are the contents of Investigational New Drugs Application (IND)?
- Discuss the various optimization parameters to be considered during technology transfer.
- Explain various parameters to be considered during selection of container closure system for parenteral formulation.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write a note on Bulk Active Chemical Post Approval Changes (BACPAC).
- Discuss the product registration guidelines as per CDSCO.
- How is a polymorphic form of drug deduced? Why it is essential in formulation development.
- What is Pilot Plant? Explain the factors to be considered in the organization of pharmaceutical Pilot Plant.
- Explain how the development of Master Formula Records and Batch Manufacturing records play an important role in Pilot Plant Scale Up Studies.
- Discuss the various issues faced during modern drug packaging system.
- List and explain QC tests for Blister packaged products.
- Define and explain Primary and Secondary packing materials
- Write a note Development Report.
- Explain metal as the container for the Pharmaceutical Packaging.
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