Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2017 December (Master of Pharmacy) 1st Year 5104 Product Development And Technology Transfer Previous Question Paper

Rajiv Gandhi University of Health Sciences
First Semester M. Pharm Degree Examination - Dec-2017
[Time: 3 Hours]
[Max. Marks: 75]
Product Development and Technology Transfer
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
1.
What are the contents of Investigational New Drugs Application (IND).
2.
Write in detail about Pre-formulation protocol for Tablet dosage forms.
3.
Explain various parameters to be considered during selection of container closure system for
Parenteral formulation.
4.
What controls need to be ensured when a technical process is transferred from development
site to client site?
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Discus the requirement of Supplemental New Drug Application (SNDA).
6.
Discuss the Product registration guidelines as per CDSCO.
7.
Write a note on Stability testing during product development.
8.
How pre-formulation study for purity, impurity profiling is carried out?
9.
What is a pilot plant? Explain the factors to be considered in the organization of pharmaceutical
pilot plant.
10.
Explain how the development of master formula records and batch manufacturing records play
an important role in pilot plant scale up studies.
11.
Explain the protocol for pilot plant scale up for tablets production.
12.
List and explain QC tests for blister packaged products.
13.
Explain metal as the container for the pharmaceutical packaging.
14.
Explain various Qualitative and quantitative models of technology Transfer.
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