Note: Answer all questions. Draw labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) FirstRanker.com 3 x 15 = 45 Marks
- What are the contents of Investigational New Drugs Application (IND)?
- Write in detail about Pre-formulation protocol for tablet dosage form.
- Explain various parameters to be considered during selection of containers closure systems for parenteral formulation.
- What controls need to be ensured when 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 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 Pilot Plant? Explain the factors to be considered in the organization of Pharmaceutical pilot plant.
- Explain how development of Master Formula and Batch Formula manufacturing records play an important role in pilot plant scale up for tablets production.
- Define and explain QC tests for blister packaged products.
- List and explain QC tests for parenteral products.
- Explain metal as the container for the Pharmaceutical Packaging.
- Explain various Qualitative and Quantitative models of technology transfer.
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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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