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PDTT Blueprint March 2025

The document outlines the syllabus for the M.Pharm QA, Semester I course at VES College of Pharmacy, focusing on Product Development and Technology Transfer. It details various topics including drug discovery principles, preformulation studies, pilot plant scale-up, pharmaceutical packaging, technology transfer, and the use of Quality by Design (QbD) in product development. Additionally, it specifies excluded topics from the reduced syllabus exam.

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Mayuresh Katkar
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83 views2 pages

PDTT Blueprint March 2025

The document outlines the syllabus for the M.Pharm QA, Semester I course at VES College of Pharmacy, focusing on Product Development and Technology Transfer. It details various topics including drug discovery principles, preformulation studies, pilot plant scale-up, pharmaceutical packaging, technology transfer, and the use of Quality by Design (QbD) in product development. Additionally, it specifies excluded topics from the reduced syllabus exam.

Uploaded by

Mayuresh Katkar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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VES COLLEGE OF PHARMACY (Autonomous)

Hashu Advani Memorial Complex, Behind Collector Colony, Chembur (E), Mumbai - 400 074
------------------------------------------------------------------------------------------------------------
M.PHARM. QA, SEM I (R 2024)
SUBJECT CODE: MQA104T
SUBJECT: Product Development and Technology Transfer Blueprint

Unit Name of Topic Hrs. No. of Long Answer Short


No. MCQ questions Answer
(All (Attempt any 2 questions
compulso from 3) (Attempt
ry) 20*1 2*10 any 7
Each question from 9)
can be divided 7*5
into
subquestions
1 Principle of drug discovery and 10 4 1 2
development: Introduction, Clinical
research process. Development and
informational content for
Investigational New Drugs
Application (IND), New Drug
Application (NDA), Abbreviated New
Drug Application (ANDA),
Supplemental New Drug Application
(SNDA), Scale Up Post Approval
Changes (SUPAC) and Bulk active
chemical Post approval changes
(BACPAC), Post marketing
surveillance, Product registration
guidelines – CDSCO, USFDA.
2 8 3 - 2
Preformulation studies:
Introduction/concept, organoleptic
properties, purity, impurity profiles,
particle size, shape and surface area.
Solubility, Methods to improve
solubility of Drugs: Surfactants & its
importance, co-solvency. Techniques
for the study of Crystal properties and
polymorphism. Pre-formulation
protocol, Stability testing during
product development.
3 7 3 1 1
Pilot Plant Scale up: Concept,
Significance, design, layout of pilot
plant scale up study, operations, large
scale manufacturing techniques
(formula, equipment, process,
stability and quality control) of
solids, liquids, semisolid and
parenteral dosage forms. New era of
drug products: opportunities and
challenges.
4 Pharmaceutical packaging: 8 4 - 2
Pharmaceutical dosage form and their
VES COLLEGE OF PHARMACY (Autonomous)
Hashu Advani Memorial Complex, Behind Collector Colony, Chembur (E), Mumbai - 400 074
------------------------------------------------------------------------------------------------------------
packaging requirements.
Pharmaceutical packaging materials,
Medical device packaging, Enteral
Packaging, Aseptic packaging
systems, Container closure systems,
Issues facing modern drug packaging,
Selection and evaluation of
pharmaceutical packaging materials.
Quality control test: Containers,
closures and secondary packing
materials.
5 Technology Transfer: Development 10 4 1
of technology by R & D, Technology 1
transfer from R & D to production,
Optimization and Production,
Qualitative and quantitative
technology models. Documentation
in technology transfer: Development
report, technology transfer plan and
Exhibit
6 Use of QbD in product development: 5 2 - 1
QbD tools and methodologies: risk
assessment, design of experiments
(DoE), control strategy with case
studies
20M 20M 35M

The following topics are not included in the reduced syllabus exam

Unit 1: Product registration guidelines – CDSCO, USFDA.

Unit 2: Particle size, shape and surface area. Solubility, Methods to improve solubility of Drugs:
Surfactants & its importance, co-solvency. Stability testing during product development.

Unit 3: Quality control of solids, liquids, semisolid and parenteral dosage forms

Unit 4: Quality control test: Containers, closures and secondary packing materials.

Prepared by

Dr. Harsha Kathpalia


Chairperson

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