Wednesday, February 8, 2023

Dr. A.P.J. Abdul Kalam University M.Pharm (Quality Assurance) II SEM Pharmaceutical Manufacturing Technology [MQA204T] June 2021 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Quality Assurance)

Second Semester Examination, June-2021

Pharmaceutical Manufacturing Technology [MQA204T]

Time: 3:00 Hrs Max Marks 75

Note : (i) Attempt any five questions.

(ii) All questions carry equal marks.

Q.1 (a) Write the manufacturing flowchart of small volume parentral

(SVP) and the in process quality control test for the same?

(b) What are the in process quality control test for suspension and

manufacturing flowchart of suspension?

Q.2 (a) Write the principle, process and equipment used in Lyophilisation

technology?

(b) Write a detail note on advanced sterile manufacturing technology?

Q.3 (a) Write a note on process atomization in pharmaceutical industry

with specific reference to manufacturing of sterile semisolids?

(b) Write a note on process atomization in pharmaceutical industry

with specific reference to manufacturing of small volume parenterals

and large volume parenterals?

Q.4 (a) Write a short note on any two: A. Cleaning in place B. Sterilization

in place C. Form Fill Seal Technology.

(b) Write in detail about in process quality control tests for compressed

tablets and the manufacturing flowcharts of the same?

Q.5 (a) Write in detail about in process quality control tests for coated

tablets and the manufacturing flowcharts of the same?

(b) Write in detail about in process quality control tests for hard

gelatine capsule and the manufacturing flowcharts of the same?

Q.6 (a) Write in detail about in process quality control tests for soft

gelatine capsule and the manufacturing flowcharts of the same?

(b) What are the legal requirements for the development of

Pharmaceutical industry?

Q.7 (a) What are the factors influencing the Plant layout and the legal

requirements for the sterile and aseptic area layout?

(b) Write a short note on general principles of Production planning and

the production system?

Q.8 (a) Define Quality by design. Why QbD is required, its advantages and

elements of QbD?

(b) Explain the terms: A. QTPP B. CMA C. CQA D. CPP E. RLD

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