Seat No.: _____ Enrolment No.

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GUJARAT TECHNOLOGICAL UNIVERSITY

M.Pharm - SEMESTER– II • EXAMINATION – SUMMER -2018

Subject Code: MQA204T Date: 21/05/2018

Subject Name: PHARMACEUTICAL MANUFACTURING TECHNOLOGY
Time:10:30AM TO 02:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessarys.
3. Figures to the right indicate full marks.

Q.1 (a) What are the advantage of good lay out. Draw a simple layout of 06
pharmaceutical production plant along with F & D section?
(b) Write down notes on limitation and step involved in planning. 05
(c) Briefly explain factor responsible for the plant location choice. 05

Q.2 (a) Explain briefly about classification of glass according to USP. 06

(b) Define in process quality control. Explain quality controls test for sterile dosage 05
form.
(c) Notes on Needle free injection and FFS. 05
Q.3 (a) Write a note on Evaluation of stability of packaging material. 06
(b) Discuss the objectives of production planning and scheduling. 05
(c) Explain Lyophilization technology process with principles. 05
Q.4 (a) Describe in process quality control evaluation of capsules and tablet dosage 06
forms.
(b) Write note on testing of packaging material. 05
(c) What factors affect drug product CQA. 05
Q.5 (a) Why QbD is required? Explain risk assessment in brief. 06
(b) How can PAT improving quality and reducing cost, explain it in brief. 05
(c) What are the factor influence the choice package. 05
Q. 6 (a) Explain in brief type of containers. 06
(b) Notes on type of plastics. 05
(c) Discuss type of film wrappers. 05
Q.7 (a) Explain quality control test for glasses. 06
(b) Discuss assurance quality aspects of packaging. 05
(c) Notes on drug plastic consideration. 05

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