Quality must be built into the product, it cannot be inspected into it. The Pharmaceutical industries are experiencing a “knowledge and experience deficit” regarding the use of QbD concepts.

1. TRAINER: MD. ZAKARIA FARUKI
Orion Pharma Limited
Dhaka, Bangladesh Slide 1 of 36
TRAINING ON
Pharmaceutical Quality
by Design (QbD)
ORION

2. Introduction to QbD Approach
Quality by Design (QbD) is a Quality System for
managing a product’s lifecycle which is emerging
to enhance the assurance of safe & effective drug
supply to the consumer, and also offers promise
to significantly improve manufacturing quality
performance.
The Quality of the pharmaceutical product can be
evaluated by in vivo or in vitro performance tests.
Quality by design assures in vitro product
performance and In vitro product performance
provides assurance of in vivo product
performance. “Hence Quality by design relate to
Product Performance”
ORION
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3. QbD History & Recommendation
 Quality by design (QbD) is a concept first developed by the
quality pioneer Dr. Joseph M. Juran
 Dr. Juran believed that quality should be designed into a
product, and that most quality crises and problems relate to
the way in which a product was designed in the first place.
 Woodcock defined a high-quality drug product as a product
free of contamination and reliably delivering the therapeutic
benefit promised in the label to the consumer.
 The US Food and Drug Administration (FDA) encourages
risk-based approaches and the adoption of QbD principles in
drug product development, manufacturing, and regulation.
 FDA’s emphasis on QbD began with the recognition that
increased testing does not necessarily improve product
quality. Quality must be built into the product.
Training on QbD Conducted by Md. Zakaria Faruki
ORION
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4. Definitions
 Quality:
The suitability of either a drug substance or a
drug product for its intended use. This term
includes such attributes as the identity, strength,
and purity (ICH Q6A). Pharmaceutical quality
refers to product free of contamination and
reproducibly delivers the therapeutic benefit
promised in the label to the consumer.
 Quality by Design (QbD):
A systematic approach to development that
begins with predefined objectives and
emphasizes product and process understanding
and process control, based on sound science
and quality risk management.
ORION
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5. Principle QbD Concepts ORION
Training on QbD Conducted by Md. Zakaria Faruki
 Risk and knowledge
based decisions
 Systematic
approaches for
process development
 Continuous
Improvement
 This leads to
capable processes
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6. ORION
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7. ORION
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8. ORION
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9. ORION
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10. Training on QbD Conducted by Md. Zakaria Faruki
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11. ORION
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12. ORION
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13. ORION
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14. ORION
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15. QTPP & CQAs
 Quality Target Product Profile (QTPP): A prospective summary
of the quality characteristics of a drug product that ideally will
be achieved to ensure desired quality, taking into account
safety and efficacy of a drug product. By Beginning with the
end in mind, the result of development is a robust formulation
and manufacturing process with an acceptable control strategy
that ensures the performances of the Drug Product.
 Critical Quality Attributes (CQAs): A CQA is a physical,
chemical, biological, or microbiological property or
characteristic that should be within an appropriate limit, range,
or distribution to ensure the desired product quality. CQAs are
generally associated with the drug substance, excipients,
intermediates (in-process materials), and drug product.
ORION
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16. Training on QbD Conducted by Md. Zakaria Faruki
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23. Training on QbD Conducted by Md. Zakaria Faruki
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26. Training on QbD Conducted by Md. Zakaria Faruki
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27. Traditional & QbD
Approaches
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28. Quality by End Product Testing ORION
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29. Quality by Design QbD ORION
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30. Training on QbD Conducted by Md. Zakaria Faruki
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31. Training on QbD Conducted by Md. Zakaria Faruki
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32. What are the Barriers to QbD?
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33. Industry Perspective &
Implementation of QbD
From the pharmaceutical industry’s perspective, QbD requires
development of a fundamental scientific understanding of critical
processes and product attributes, establishment of design
controls and testing based on product quality and within the limits
of scientific understanding, and use of knowledge gained over a
product’s life cycle to operate in an environment of continuous
improvement. Critical to QbD is sound science rooted in quality
risk management (QRM). As stated previously, QbD concepts are
not new; rather, “such innovations are the application of those
principles in the development, submission, and manufacturing of
drug products and drug substances”
The biopharmaceutical industry is currently experiencing a
“knowledge and experience deficit” regarding the use of QbD
concepts. Typically, manufacturers learn through experience, and
until they have successfully used QbD with positive regulatory
submissions, there will continue to be trepidation about using the
QbD framework in drug product development.
ORION
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34. Conclusion
 Quality by Design is intended to enhance process knowledge
and is based on existing guidance and reference documents
 QbD can be viewed as a process defined by series of document
requirements as per process knowledge and understanding.
 QbD can be applied to legacy and new products, but the
supporting document package may differ.
 The QbD suite of documents are “alive”. They can and should be
revised as the knowledge base changes.
 The goals of implementing pharmaceutical QbD are to reduce
product variability and defects, thereby enhancing product
development and manufacturing efficiencies and post
approval change management.
 Finally, QbD is challenge & the current challenges to QbD
implementation from an industry perspective are numerous
because industry has yet to fully embrace its application to
pharmaceutical product development.
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35. Training on QbD Conducted by Md. Zakaria Faruki
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36. Training on QbD Conducted by Md. Zakaria Faruki
Intelligent peoples
don't make MISTAKES
However, mistakes make
peoples INTELLIGENT…
ORION
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