Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code:930104 Date: 17/11/2018
Subject Name: Validation And Product Development
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

Explain the importance of instrument validation and describe the procedure for validation of UV-Spectrophotometer.
06

Define process validation. Suggest its options and explain its importance in pharmaceutical industry.
05

What is SOP? Describe the SOP for dissolution test apparatus.
05
Q.2

Explain IQ, OQ and PQ for Hot Air Oven.
06

Describe the cleaning validation in Pharmaceutical industry.
05

Write in short about HVAC system validation.
05
Q.3

Describe the manufacturing process, design, development and in process control for liquid orals.
06

Explain pilot scale up operation.
05

Write a note on aseptic area validation.
05
Q.4

Explain the validation master plan.
06

Write a note on validation of autoclave.
05

Describe the process validation of ointment.
05
Q.5

Explain the term: Prospective validation Concurrent validation Retrospective validation.
06

What do you understand about revalidation? Explain the merits and demerits of revalidation.
05

Describe the validation protocol of capsule filling machine.
05
Q. 6

What are the limitations of sterility test? Explain techniques of rapid or real time sterility test.
06

Describe validation of water system for pharmaceuticals.
05

Write a note on packaging material for parenteral products.
05
Q.7

Explain the cause and effect diagram for process of tablet manufacturing.
06

Write a note on vendor certification.
05

Describe the process for qualification of tablet compression machine.
05