Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA103T Date: 05/01/2019
Subject Name: Quality Control and Quality Assurance
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

Discuss the importance of eCTD.
06

Write a note on handling of waste and scrap disposal.
05

How to prevent mix-ups and cross contamination in manufacturing operation?
05
Q.2

Discuss different methods for the determination of shelf life of a product.
06

Explain the guidelines for sanitation of manufacturing premises.
05

Write a note on scope and importance of intellectual property rights.
05
Q.3

Write note on submission documents for regulators DMFs.
06

How to write Standard operating procedures with one example.
05

Write good practices followed sampling of raw materials.
05
Q.4

Discuss about purchase specifications and maintenance of stores for raw materials.
06

What are the current GMP guidelines for manufacturing of parenteral products?
05

Describe the objectives and constitutions of ICH.
05
Q.5

What are the different records maintained in pharmaceutical company? Describe the content of master batch record.
06

Write a note on protocol for conduct of non clinical testing.
05

Describe about CPCSEA guidelines in detail.
05
Q. 6

Write about the responsibilities of personnel working in a pharmaceutical manufacturing unit.
06

Describe the process and benefits of WHO certification.
05

Write a note on scope of GLP.
05
Q.7

Write a note on cGMP guidelines according to schedule M.
06

Explain the difference between Quality Control and Quality Assurance activities.
05

Give details about batch manufacturing record.
05