Rajiv Gandhi University of Health Sciences
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M.Pharm Degree Examination - May/June
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First Semester[Time: 3 Hours] [Max. Marks: 75]
Product Development and Technology Transfer
Q.P. CODE: 5104
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- What are the contents of Investigational New Drugs Application (IND).
- Write in detail about Pre-formulation protocol for Tablet dosage forms.
- Explain various parameters to be considered during selection of container closure system for Parenteral formulation.
- What controls need to be ensured when a technical process is transferred from development site to client site?
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Discuss the requirement of Supplemental New Drug Application (SNDA).
- Discuss the Product registration guidelines as per CDSCO.
- Write a note on Stability testing during product development.
- How pre-formulation study for purity, impurity profiling is carried out?
- What is a 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.
- Explain the protocol for pilot plant scale up for tablets production.
- List and explain QC tests for blister packaged products.
- Explain metal as the container for the pharmaceutical packaging.
- Explain various Qualitative and quantitative models of technology Transfer.
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