Wednesday, January 25, 2023

Dr. A.P.J. Abdul Kalam University M PHARMACY I SEM (ALL BRANCH) Product Development and Technology Transfer (MQA104T) Dec 2020 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Quality Assurance)

First Semester Examination, Dec-2020

Product Development and Technology Transfer (MQA104T)

Time: 3:00 Hrs Max Marks 75

Note: Attempt any five questions. All questions carry equal marks.

Q.1 (a) Describe quality control test of containers and closure.

(b)Write Detail note on selection and evaluation of pharmaceutical packaging


Q.2 (a) Elaborate concept, design and layout of pilot plant scale up study.

(b) Describe in detail manufacturing techniques at large scale.

Q.3 (a) Explain development report and technology transfer plan.

(b) Explain new era of drug products opportunities and its challenges.

Q.4 (a) Describe in detail product development guideline.

(b) Discuss development and information content for IND.

Q.5 (a) Explain techniques used for the study of crystal properties and


(b) Describe concept of organoleptic properties, purity and impurity in

preformulation study.

Q.6 (a) Discuss qualitative and quantitative technology models. (Technology


(b) Describe in detail bulk active chemical post approval changes.

Q.7 Write short note in (Any two)-

(a) Co-Solvent

(b) Surfactants

(c) Preformulation protocols

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