The key elements of QbD include establishing a quality target product profile, identifying critical quality attributes, performing risk assessments, defining a design space, implementing a control strategy, and enabling continual improvement. QbD helps ensure better designed products and manufacturing processes with fewer problems, satisfying patients' needs more effectively and efficiently. It aims to eliminate waste and reduce costs. While achieving full understanding and implementation of QbD remains an ongoing challenge, its adoption is expected to realize significant benefits for both industry and regulators.

1. QUALITY BY DESIGN
Sahil Kalyan
M.Pharm 1st Year
Quality Assurance

3. Outline
 Quality by Design
 What does it in mean?
 Concepts and background of QbD
 Elements of Quality by Design
 Why Quality by Design?
 A look into the future

4. “Quality by Design”
What does it mean?
 According to ICH Q8 guidelines, QbD is defined as, “A
systematic approach to development that begins with
predefined objectives & emphasizes product and process
understanding and process control, based on sound science
and quality risk management”.

5. ICH Q8, Q9, Q10: The foundation of
QbD
Desired
State
Pharmaceutical
Development
(Q8)
Quality
Risk
Management
(Q9)
Quality
Systems
(Q10)

6. Concepts & background of QbD
 Concept first outlined by Joseph M. Juran
 In 1970, Toyota pioneered many QbD concepts
 In 1990, Medical devices began to incorporate
Quality by Design aspects
 In mid-2002 FDA published a concept paper
on cGMP for 21st century

7. Elements of
Quality by
Design
Quality target product profile
Critical quality attribute
Risk assessment
Design space
Control strategy
Continual
improvement

8. Quality target product profile
 QTPP is defined as, “A prospective summary of
the quality characteristics of a drug product that
ideally will be achieved to ensure the desired
quality, taking into account safety and efficacy
of the drug product
 It includes dosage form, route of administration,
dosage strength, delivery system, stability, etc.

9. Critical quality attributes
 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 and drug
product

10. Risk assessment
 Linking Material Attributes and Process
Parameters to drug product CQAs
 Risk assessment is a valuable science based
process used in quality risk management that
can aid in identifying which material attributes
and process parameters potentially have an
effect on product CQAs

11. Design space
The relationship between the process inputs (material
attributes and process parameters) and the critical
quality attributes can be described in the design
space
 A design space can be described in terms of ranges
of material attributes and process parameters
 A design space is a way to represent the process
understanding that has been established

12. Control strategy
A control strategy can include, but is not limited
to, the following:
• Control of input material attributes
• Product specifications
• Control for unit operations
• In process or real-time release testing

13. Product lifecycle management and
continual improvement
 Throughout the product lifecycle,
companies have opportunities to
evaluate innovative approaches to
improve product quality
 Process performance can be
monitored to ensure that it is
working as anticipated

14. Why Quality by Design?

15.  QbD ensures better design of products with less
problems in manufacturing
 It satisfies patient’s needs:
 Efficacy
 Safety
 Value
 Allows continuous improvement in products &
manufacturing process
 Quality by Design-based applications are processed
63% faster than traditional submissions by FDA
 Eliminates waste and reduce costs

16. Quality by Design – Future Outlook
 Ongoing challenges
 Achieve clear and common understanding of QbD
concept
• Greater clarity on QbD for biological products
 Development of regulatory processes
 Need international harmonization and collaborative
efforts
 Shift “wait and see” attitude to an active participation
for both industry and regulatory agencies

17. Quality by Design – Future Outlook
 Desired future state
 Industry and regulators fully embrace QbD and
integrate the concept into drug product development
and commercialization
 Agency/industry sponsored pilot programs
 Significant benefits realized
 Real time release
 Consistent product quality
 Waste reduction
 Elimination of variations

18. References
1. Lionberger RA, Lee SL, Lee L, Raw A, Yu LX. Quality by Design: Concepts
for ANDAs. AAPSJ 2008;10(2):268-276.
2. Chavan SD, Pimpodkar NV, Kadam AS, Gaikwad PS. Quality by Design.
JPQA 2015;1(2):18-24.
3. ICH Guideline Q8(R2). Pharmaceutical development
4. ICH Guidelines Q9. Quality Risk Management
5. ICH Guidelines Q10. Quality Systems
6. Quality by Design. Available at:
https://en.Wikipedia.org/wiki/Quality_by_Design. Accessed November 19,
2017

19. THANK YOU FOR YOUR
ATTENTION
Questions, suggestions and comments are
welcome