Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: 910204 Date: 05/01/2019
Subject Name: Good manufacturing and Good Laboratory 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

Describe concepts of QA& GMP.
06

Describe in detailed general consideration for factory premises.
05

Write general guidelines given for personnel selection and training.
05
Q.2

Write short note on cleaning, maintenance and sterilization of
Equipment.
06

Write brief note on Selection of vendor
05

Write note on master batch documents for tablet dosage form.
05
Q.3

Write an account of Good Warehouse Practices
06

Write a short note on in process quality controls of sterile dosage forms.
05

Write short note on Quality Audit.
05
Q.4

Discuss line clearance regarding packaging and labeling control.
06

What are reserve samples? Discuss briefly their significance.
05

Write a note on Testing and release of finished product.
05
Q.5

Describe waste and scrap disposal procedures.
06

Write note on complaint product recall.
05

Write a short note on GLP.
05
Q. 6

Describe the elements with significance of WHO certification scheme.
06

Describe the raw material specifications with suitable examples.
05

Testing of packaging materials.
05
Q.7

What are SOPs? Give objectives of SOP. Enumerate the topics of SOP.
Describe the general format for SOP.
06

Write a note on Good Distribution Practices
05

Write a note on Self Inspection
05