Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MPT104T Date: 07/01/2019
Subject Name: Good manufacturing practice and process validation
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

Write a note on process analytical technology.
06

Explain significance of GMP and GLP in drug development process.
05

Describe statistical procedures used in assay development.
05
Q.2

Discuss basic concepts of quality assurance.
06

Enlist inferential statistical procedures for hypothesis testing and describe any one.
05

Describe analytical method validation as per ICH guidelines.
05
Q.3

Describe in-process quality control tests for parenteral formulations.
06

Explain role of raw material testing in quality assurance of formulations.
05

Write a note on calibration master plan.
05
Q.4

What is pharmaceutical validation? Describe its scope and merits.
06

Discuss ICH and WHO guidelines for calibration of pharmaceutical weighing balance.
05

List out types of validation. Discuss validation of specific dosage form
05
Q.5

Write a note on ICH Q8 guideline for pharmaceutical development.
06

Role of in-process quality control in assuring quality of finished product.
05

Write a note on URS.
05
Q. 6

Discuss Pharmaceutical Quality System as per ICH guideline.
06

Write a note on ICH Q9 guideline.
05

Discuss good manufacturing practices for active pharmaceutical ingredients.
05
Q.7

Describe in detail quality audits.
06

Discuss ICH and WHO guidelines for validation of rotary tablet press.
05

Describe in-process quality control tests for solid oral dosage forms.
05