Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm. SEMESTER I • EXAMINATION SUMMER -2018
Subject Code: 910202 Date: 07/05/2018
Subject Name: Industrial Pharmacy Practice
Time: 02:30PM TO 05:30PM 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

Prepare departmental layout with equipment required for liquid orals.
06

Give a layout of cosmetic manufacturing area.
05

Describe sanitation facility services in pharmaceutical premise.
05
Q.2

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.3

Describe objectives of scale-up techniques. Write a note on pilot plant operation.
06

Enlist equipments used for granulation process. Explain RMG.
05

What is cross contamination? Describe methods to control cross contamination.
05
Q.4

Enlist and discuss selection criterion for pharmaceutical industry location.
06

Discuss inventory control giving suitable examples.
05

Give full form of BMR and BPR. Discuss its significance in manufacturing of
parenteral dosage forms.
05
Q.5

Enlists merits and demerits of cGMP guideline of India.
06

Write note on HVAC in pharmaceutical factory.
05

Describe the parameters to be considered during the scale up of tablet Coating.
05
Q. 6

Discuss personnel facilities required in pharmaceutical industry.
06

Discuss the important factors for material selection in pharmaceutical plant construction.
05

Describe the documentation required for batch release.
05
Q.7

Explain qualitative and quantitative departmental layout for Sterile dosage forms.
06

Write a note on Master Formula record
05

Explain validation protocol and its contents.
05