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
material.
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
polymorphism.
(b) Describe concept of organoleptic properties, purity and impurity in
preformulation study.
Q.6 (a) Discuss qualitative and quantitative technology models. (Technology
transfer).
(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
Scanned Copies:
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