The seminar presentation introduced the concepts of quality and Quality by Design (QbD) in pharmaceutical development. It explained that QbD is a systematic approach that emphasizes product and process understanding through predefined objectives, process control, and quality risk management. The presentation covered key QbD elements like the target product quality profile, critical quality attributes, material attributes, process parameters, design space, control strategy, and risk assessment. It discussed how applying a QbD approach improves manufacturing quality performance and ensures safe, effective drug supply. The importance of QbD for formulation and development was highlighted through elements like quality target product profile, initial risk assessment, design development strategies, and scale-up from lab to commercial scale.

1. A Seminar on...
Quality-by-Design in Pharmaceutical Development
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Presented by-
Vijay verma
M.Pharm 2nd Semester
Roll No. 8561013
University Institute Of Pharmacy

2. • Introduction to Quality
• Quality by Design (QbD)
• Significance of Quality by Design
• QbD frame (in ICH docs)
• Use of QbD approach
• Target product quality profile
• Critical quality attributes
• Material attributes
• Process parameter
• Design space & determination
• Control strategy
• Risk assessment
• Importance of QbD for Formulation and Development
• Conclusion
• References
Content
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3. The suitability of either a drug substance or a
drug product for its intended use.
The term include such attributes as the
identity, strength & purity
It also refer to product free of contamination
and reproducibly delivers the therapeutic
benefit promised in the label to consumer
Quality
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4. A systematic approach to development that begins
with predefined objectives and emphasizes
product and process understanding and process
control, based on science and quality risk
management
Quality by Design is emerging to enhance the
assurance of safe, effective drug supply to
consumer and also offer promise to significantly
improve manufacturing quality performance.
Quality by Design
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17. • Quality target product profile
• Critical quality attributes
• Initial risk assessment for drug formulation
1. Selection of Excipients
2. Excipients compatibility studies
3. Development of formula for initial formulation development
• Design development strategies
• Scale up from lab to pilot scale and then
commercial scale
Importance of QbD for Formulation and
Development
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