The document provides an overview of Quality by Design (QbD), including its key elements and benefits. QbD is defined as a systematic approach to development that emphasizes product and process understanding based on sound science and quality risk management. The main elements discussed are the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment, design space, control strategy, and continual improvement. The benefits of QbD include higher assurance of quality, cost savings, reduced compliance issues, and opportunities for innovation and process improvement. Barriers to implementing QbD include challenges relating to culture, business priorities, and gaining experience with the new concepts.

1. PRESENTED BY :
Ms . Malunjkar Jyotsna Sampat
F . Y . M . Pharm
QUALITY ASSURANCE
Quality by Design(QbD)
GOVERNMENT COLLEGE OF PHARMACY , AMRAVATI

2. WHAT IS QbD?
WHY QbD?
HOW IT APPLY ON DEVELOPMENT?
RELATION OF ICH GUIDELINES AND QbD
ELEMENTS OF QbD
QTPP
CQA
RISK ASSESMENT
DESIGN SPACE
CONTINUAL IMPROVEMENT
BARRIERS TO QBD
CONCLUSION
REFERENCES
CONTENT

3. “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.”
What is Quality by Design (QbD)?
3

4.  Higher level of assurance of product quality
 Cost saving and efficiency for industry
 Minimize/eliminate potential compliance actions
 Provide opportunities for continual improvement
 Facilitate innovation
 Enhance opportunities for first cycle approval
 Increase process capability and reduce product variability
and defects
WHY QbD?
4

5. COMPARISION BETWEEN QbD STATE AND
CONVENTIONAL STATE
5

6. HOW IT APPLY ON DEVELOPMENT?
6

7. RELATION OF ICH GUIDELINES AND QBD
7

8. ELEMENTS OF QbD
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT8

9. 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 drug product :ICH Q8
(R2)
Quality Target Product Profile (QTPP)
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT 9

10. QTPP
Dissolution?
Dose?
Appearance?
Hardness
Content Uniformity
PATIENT
Identify what is critical
to patient and link to
drug product
10

11. From beginning to end , the result of
development is a robust formulation
and manufacturing process with an
acceptable control strategy that
ensures the performance of the drug
product
“Begin with the end in mind”
QTPP
11

12. Necessary Elements
• Quality characteristics
• Pharmacokinetic characteristics
• Therapeutic effect
• Target patient population
• Shelf life
Desired Elements
• Dosage form.
• Route of administration
• Clinical setting
• Primary/secondary packaging
QTPP
12

13. Critical Quality Attributes (CQAs)
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 : ICH Q 8 (R2).
• CQA are associated with :
 Drug substance
 Excipients
 intermediats
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT 13

14. HOW A QUALITY ATTRIBUTE IS
DEEMED CRITICAL ?
QTPP
Potential impact
to Safety,Efficacy
and Quality ?
Non -
critical
severity critical
Continual improvement
Low risk
High risk
YES
NO
CQAs
14

15. QTPP TO CQA
QTPP
SAFETY
AND
EFFICAC
Y
POTENCY
PURITY
IDENTITY
POTENTIAL
QUALITY
ATTRIBUTES
C
Q
A
s
CRITICAL
ASSESM-
ENTS
CQAs
15

16. Risk assesment
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT
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.
Critical
material
attributes
Critical
quality
attributes
Critical
process
parameters
16

17. RISK ASSESMENT
PRINCIPLES OF QUALITY RISK MANAGEMENT
Two primary principles:
The evaluation of the risk to quality
should be based on scientific
knowledge and ultimately link to the
protection of patient
The level of effort , formality and
documentation of quality risk
management process should be
commensurate with level of risk
17

18. Risk management methodology
ICHQ9 link back to patient risk
RISK ASSESMENT
design
patient
Distribution
process
facilities
manufacturingmaterials
Opportunities to impact risk using quality
risk management
18

19. Q10Q8
Risk management methodology
ICHQ9 link back to patient risk
RISK ASSESMENT
design
patient
Distribution
process
Q9
facilities
manufacturingmaterials
Opportunities to impact risk using quality
risk management
19

20. QUALITY RISK MANAGEMENT
PROCESS – ICH Q9
RISK ASSESMENT
PROCESS DEVELOPMENT
CONTROL STRATEGY
DEVELOPMENT
CONTINUAL
IMPROVEMENT
OF THE PRODUCT20

21. ACCORDING TO ICH GUIDELINES Q8(R2):
The multidimensional combination and interaction of
input variables and process parameters that have been
demonstrated to provide assurance of quality.
• REGULATORY FLEXIBILITY : Working within the design
space is not considered as a change.
• IMPORTANT : Design space is proposed by the applicant
and is subject to regulatory assessment and approval.
Design space
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT 21

22. PROCESS
(OR PROCESS STEP)
Input
Material
Input Process
Parameters
DESIGN
SPACE
PRODUCT
(OR INTERMEDIATES)
DESIGN SPACE
DESIGN SPACE AND QUALITY
CONTROL STRATEGY
22

23. Control strategy
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT
A planned set of controls, derived from current product and
process understanding that ensures process performance
and product quality.
The controls can include:
parameters and attributes related to
 drug substance
 drug product materials
 facility and equipment
 operating conditions
 in-process controls
 Finished product specifications
 the associated methods
 frequency of monitoring and control.
23

24. CONTROL STRATEGY
PROCESS
(OR PROCESS STEP)
Input
Material
Input Process
Parameters
DESIGN
SPACE
PRODUCT
(OR INTERMEDIATES)
Design space and
quality control strategy
Process
variability
Process controls
Monitoring of parameters
or attributes
24

25. Flexibility for movement within design space
 Wider range of material attributes or process
parameters
 No reporting if moving operating range within
design space
 Potential scale or equipment change without
supplement (subject to regional regulatory
requirements)
Continual improvement
QTPP
CQAs
RISK ASSESMENT
DESIGN SPACE
CONTROL STRATEGY
CONTINUAL
IMPROVEMENT 25

26. Continual improvement
of the product
CONTINUAL
IMPROVEMENT
INPUTS
Expanded body
of knowledge
Product lifecycle
management
26

27. Barriers to QbD
Culture challenges
 Move from prescriptive approach
 More sharing of scientific and risk information
Business challenges
 Business justification
 Management support
 Budgeting silos across business units
Implementation challenges
 Collaboration between functions
 Experience with new concepts
 Workload and resource limitations
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28. CONCLUSION
 Quality by Design is intended to enhance process knowledge and is based
on existing guidance and reference documents
 QbD is a quality system that builds on past and sets future
regulatoryExpectations.
 QbD has gain importance in the area of pharmaceutical processes like drug
development, formulations, analytical method and biopharmaceuticals.
 The main reason behind adoption of QbD is the regulatory requirements.
 Pharmaceutical industry needs a regulatory compliance so as to get their
product approved for marketing.
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