MODEL PAPER

End Semester Examination, December- 2023

Program: B. Pharm
Semester: VII
Subject: Industrial Pharmacy – II
Subject Code: BP702T

Course Learning Objective (CLO)

CLO 1: Know the process of pilot plant and scale up of pharmaceutical dosage forms
CLO 2: Understand the process of technology transfer from lab scale to commercial batch.
CLO 3: Know different Laws and Acts that regulate pharmaceutical industry
CLO 4: Understand the approval process and regulatory requirements for drug products
CLO 5: Understand about all the regulatory requirements.

Unit I
S Questions CO Bloom’s Taxonomy
No. Level
Section II Questions for 5 marks
1 What do you mean by emulsion? While formulation of CO1 Understand
emulsions what are the purposes and agents we should keep in
mind? What are the parameters to be considered for scale up of
emulsions?
2 What do you mean by Platform Technology? What are its CO1 Remember
objectives and types?
3 Write in details about the space requirements needed while CO1 Understand
scale up.
4 What do you mean by SUPAC? Write about the levels of CO1 Understand
changes mentioned in SUPAC Guidelines.

5 Write the definition of pilot plant and scale up. Write about the CO1 Remember
major technical aspects we should keep in mind while scale up.

6 What do you mean by suspension? While formulation of CO1 Remember

suspensions what are the purposes and agents we should keep
in mind? What are the parameters to be considered for scale up
of suspensions?

7 Write about the significance and objective of pilot plant. CO1 Understand
Section III Questions for 10 marks
1 Write in details about the pilot plant scale up processes for CO1 Analyze
 solids.

2 Explain in details any ten points of GMP consideration while CO1 Understand
scale up.

3 Write in details about the general considerations we should CO1 Analyze

keep in mind while pilot plant scale up.

Unit II
S Questions CO Bloom’s Taxonomy
No. Level
Section II Questions for 5 marks
1 What do you mean by technology transfer? Write about its CO2 Understand
facts.
2 What do you mean by Acceptance Criteria, Bracketing and CO2 Understand
Change Control?
3 What do you mean by Quality Risk Management and Risk CO2 Evaluate
Assessment?
4 What do you mean by Risk Reduction and Risk CO2 Evaluate
Communication?
5 Write about packaging while technology transfer. CO2 Understand
6 Write about points to be considered in mind in equipment while CO2 Understand
technology transfer.
7 What points should analytical method transfer protocol cover? CO2 Evaluate
Section III Questions for 10 marks
1 What points to be considered in Qualification and Validation CO2 Evaluate
while Technology Transfer?
2 Write in a flowchart format overview of typical Quality Risk CO2 Understand
Management Process.
3 Briefly mention about the points to be considered in CO2 Evaluate
Technology Transfer Protocol.
Unit III
S Questions CO Bloom’s Taxonomy
No. Level
Section II Questions for 5 marks
1 Write about the areas which involves regulation of drugs. CO3 Understand
2 Write about the roles of regulatory authorities in approval CO3 Evaluate
phase and post approval phase.
3 Write a brief note on Clinical Research Team and Non Clinical CO3 Understand
Research Team.
4 Write about Carcinogenicity Study and Immunotoxicity Study CO3 Understand
5 Discuss about statistics mentioned in contents of trial protocol. CO3 Evaluate
6 Write in a flowchart form various roles of Drug Regulatory CO3 Understand
Affairs team.
7 What are the responsibilities of Drug Regulatory Affairs team? CO3 Understand
Section III Questions for 10 marks
1 Write about the responsibilities of Regulatory Affairs CO3 Understand
Professionals.
2 Write in details about Metabolism Study. CO3 Evaluate
 3 Write in brief about contents of a trial protocol. CO3 Evaluate
Unit IV
S Questions CO Bloom’s Taxonomy
No. Level
Section II Questions for 5 marks
1 Write about the characteristics of TQM. CO4 Understand
2 Write in details about the benefits of TQM. CO4 Understand
3 What do you mean by QbD? Write its advantages. CO4 Evaluate
4 Write about the objectives and key aspects of QbD. CO4 Understand
5 Write in details about CPP and CQA. CO4 Evaluate
6 Write about the characteristics of Six Sigma. CO4 Evaluate
7 Define OOS. Write in a schematic form the investigation of CO4 Understand
OOS.
Section III Questions for 10 marks
1 Write in details about ISO 9000 Series. Write its advantages CO4 Understand
also.
2 Write about the benefits of accreditation. CO4 Evaluate
3 Write in details about the principles and benefits of GLP. CO4 Evaluate
Unit V
S Questions CO Bloom’s Taxonomy
No. Level
Section II Questions for 5 marks
1 Write in a flowchart form the Organization of CDSCO. CO5 Evaluate

2 Write in details about any five functions of Central Drug CO5 Understand
Testing Laboratories.

3 Write in details about the responsibilities of Central Authority. CO5 Understand

4 Write in details about the functions and responsibilities of State CO5 Understand
Licensing Authority.

5 Write in details about the functions of Port Offices of CDSCO. CO5 Evaluate

6 Write about the functions of CDSCO in center. CO5 Evaluate

7 Write about the DTAB. CO5 Understand

Section III Questions for 10 marks
1 Write a detailed note on process of drug regulation. CO5 Understand

2 Write about how to obtain COPP. Who can apply for COPP? CO5 Evaluate
Process to apply COPP in brief.

3 What do you mean by COPP? Write in details about the CO5 Evaluate
purpose, aim and scope of COPP.

Course Outcome (CO)

On the successful completion of the Course, students will be able to:-

 CO1: Know the process of pilot plant and scale up of pharmaceutical dosage forms.
 CO2: Know various considerations in development of pharmaceutical dosage forms.
 CO3: Know different Laws and Acts that regulate pharmaceutical industry.
 CO4: Knowledge on regulatory affairs and regulatory requirements for drug approval.
 CO5: Know the Indian regulatory requirements and all the mentioned approval process of new
drugs.

Prepared By: Ms. Priyadarshini Banerjee Reviewed By: Mr. Soham Koley

Disclaimer:-This is a model Question Paper. The Question in End term examination will differ
from the model Question paper. This model paper is meant for practice only.