Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm. SEMESTER I • EXAMINATION SUMMER 2017
Subject Code: 910202 Date: 01/05/2017
Subject Name: Industrial Pharmacy Practice
Time: 10:30 AM to 01:30 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

Enlist the type of utility services required for pharmaceutical factory. Explain any two in detail.
06

Describe the factors affecting selection of site for a pharmaceutical industry.
05

Discuss importance of HVAC facilities for pharmaceutical industry.
05
Q.2

Prepare departmental layout with equipment required for liquid orals.
06

Give a layout of cosmetic manufacturing area.
05

Explain fluid bed processor with its application.
05
Q.3

Discuss the equipments required in manufacturing of oral solid dosage forms as per schedule- M.
06

Enlist the equipments required for semisolid dosage forms. Describe planetary mixer in detail.
05

Write in brief about equipments used in sterile manufacturing.
05
Q.4

Design a BMR and BPR for tablet manufacturing.
06

Define validation. Discuss various types of validation.
05

Write in detail on Batch Manufacturing Record with suitable examples.
05
Q.5

Enlist the objectives of SOP. Explain format, writing style and content of SOP.
06

Give SOP for rotary tablet machine.
05

Describe the cGMP requirements for laboratory records and reports.
05
Q. 6

Write a note on inventory control.
06

Discuss in details on Material Control.
05

Discuss Routing and Scheduling in context to production planning.
05
Q.7

Define the term pilot plant. Describe pilot plant operation.
06

Explain scale-up consideration for sterile dosage forms.
05

What is dimensional analysis? How is it applied in scale up for pilot plant?
05