Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA204T Date: 22/11/2018
Subject Name: Pharmaceutical Manufacturing Technology
Time 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Write a note on Evaluation of stability of packaging material.
06

How are glass materials evaluated before being used in packaging?
05

What factors affect drug product CQA.
05
Q.2

Define production planning. Explain various procedures used for production planning.
06

Describe briefly the procedure for obtaining license for manufacturing of drug substance.
05

What are the factors influences the choice package?
05
Q.3

Explain in detail design, layout and operational facility with service for sterile product powder ready for reconstitution.
06

Explain in brief about in process quality control test for capsules and tablets.
05

Write short note on Packing material for closures for LVP Sterility testing for parental.
05
Q.4

How can PAT improving quality and reducing cost, explain it in brief.
06

Explain Lyophilization technology process with principles.
05

Notes on FFS CIP
05
Q.5

Enlist and discuss selection criterion for pharmaceutical industry location.
06

Discuss different type of problem and remedies of tablet coating.
05

Define spheronizers. Explain briefly about spheronizers process.
05
Q. 6

What is meant by Process Analytical Technology Write down current approach and limitation of QbD and PAT.
06

Explain wet coating in detail with example.
05

Notes on Particle coating Fluidized bed coating
05
Q.7

What are the advantages of good lay out. Draw a simple layout of pharmaceutical production plant along with F D section?
06

Notes on drug plastic consideration.
05

Explain quality control test for packaging material and filling equipment.
05