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QUALITY BY DESIGN
-Pratik Terse
1
Definition
• According to ICH Q8 guideline,
Quality by Design (QbD) is A
systematic approach to
development that begins with
predefined objectives and
emphasizes product & process
understanding & process
control, based on sound science
& quality risk management.
-Pratik Terse
2
Characteristics of QbD:
• Tool for focusing on efficient drug development
• Dynamic & systematic process
• Relies on the concept that Quality can be build
• Applicable to drug development
• Applicable to analytical methods
• Can implemented partially or totally
• Can be used at any time in drug life cycle
• Always encouraged by regulators
QUALITY BY DESIGN
• Eliminate batch failures
• Minimize Deviations & Costly investigation
• Avoid regulatory compliance problems
• Empowerment of technical staff
• Efficient, quick, flexible system
• Ensure consistent information
• Incorporate risk management
• Reduced end product testing
Advantages of QbD:
-Pratik Terse
3
QUALITY BY DESIGN
Elements of QbD:
• Quality Target Product Profile (QTPP)
• Critical Quality Attributes (CQA)
• Quality Risk Assessment (QRA)
• Critical Process Parameters
• Design Space
• Control Strategy
-Pratik Terse
4
QUALITY BY DESIGN
Quality Target Product Profile (QTPP):
• According to ICH Q8(R2), QTTP is “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”.
• Basically it is a tool for setting the strategy for drug development.
• Recently QTTP is widely used in development planning, clinical
and commercial decision making, regulatory agency interactions,
and risk management.
• It is the quality characteristics that the drug product should
possess in order to reproducibly deliver the therapeutic benefit
promised in the label.
• The QTTP guides formulation scientists to establish formulation
strategies and keep the formulation effort focused and efficient.
• QTPP is related to identity, assay, dosage form, purity, stability in
the label.
-Pratik Terse
5
QUALITY BY DESIGN
Critical Quality Attributes (CQA):
• Once QTPP has been identified, the next step is to
identify the relevant CQAs.
• A CQA is defined as “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 raw materials (drug
substance, excipients), intermediates (inprocess
materials), and drug product.
• Drug product CQAs are the properties that are important
for product performance, that is, the desired quality,
safety, and efficacy
-Pratik Terse
6
QUALITY BY DESIGN
Quality Risk Assessment (QRA)
• The FDA defines a Risk Management as, a strategic safety
program designed to decrease product risk by using one or
more interventions or tools.
• It is systematic process for the assessment, control,
communication and review of risks to the quality of the drug
product across the product lifecycle
• The ICH Q9 guideline: Quality Risk Management provides a
structure to initiate and follow a risk management process. The
relevant tools of QRM are as follows:
• Failure mode effects analysis (FMEA)
• Failure Mode, Effects and Criticality Analysis (FMECA)
• Fault tree analysis (FTA)
• Hazard analysis and critical control points (HACCP)
-Pratik Terse
7
QUALITY BY DESIGN
Critical Process Parameters
• A critical process parameter (CPP) is any measurable input
(input material attribute or operating parameter) or output
(process state variable or output material attribute) of a
process step that must be controlled to achieve the desired
product quality and process consistency.
• A parameter is critical when a realistic change in that
parameter can cause the product to fail to meet the QTPP.
• Thus, whether a parameter is critical or not depends on how
large of a change one is willing to consider.
• Thus the first step in classifying parameters is to define the
range of interest which we call the potential operating space
(POS).
• The POS is the region between the maximum and minimum
value of interest for each process parameter
-Pratik Terse
8
QUALITY BY DESIGN
Design Space:
• ICH Q8(R2) defines design space as the multidimensional
combination and interaction of input variables (e.g.,
material attributes) and process parameters that have
been demonstrated to provide assurance of quality.
• Working within the design space is not considered as a
change.
• Movement out of the design space is considered to be a
change and would normally initiate a regulatory post
approval change process.
• Design space is proposed by the applicant and is subject
to regulatory assessment and approval.
-Pratik Terse
9
QUALITY BY DESIGN
Control Strategy:
• ICH Q10 defines a control strategy as a planned set of
controls derived from current product and process
understanding that assures process performance and
product quality.
• The controls can include parameters and attributes related
to:
• Drug substance
• Drug product materials and components,
• Facility and equipment operating conditions
• In process controls, finished product specifications
• The associated methods and frequency of monitoring and
control.
-Pratik Terse
10
-Pratik Terse
11
Tools of QbD:
Prior Knowledge
Risk Assessment
Design of Experiment
Process Analytical Technology (PAT)
-Pratik Terse
12
Prior Knowledge:
• As per ICH guidelines prior knowledge is the
information or knowledge or skills that have
been acquired through previous experience of
similar processes and published information.
• This tool can be used at the beginning of the
developmental process and may be regularly
updated using data generated during the
process.
-Pratik Terse
13
Risk assessment
• Risk assessment is the process of understanding risk and mitigate it
through appropriate and robust control.
• It consists of the identification of Hazards and the evaluation of risk
associated with exposure to those hazards.
• There are further three components of risk assessment.
• Risk identification : The systematic use of information to identify
potential sources of hazards that are referring to the risk question or
problem description, which can include historical data theoretical
analysis.
• Risk analysis: Estimation of the risk associated with the identified
hazards.
• Risk evaluation: The comparison of the estimated risk of given risk
criteria using a quantitative or qualitative scale to determine the
significance of the risk.
-Pratik Terse
14
Design of experiment
• This tool involves setting up a series of
structured test where changes to the variables
of a process are made in planned manner.
• Then the impact of these changes on chosen
output is assess.
• This tool is very effective in identifying all the
factors that together impact the output
responses.
-Pratik Terse
15
Process analytical technology (PAT)
• The US FDA defines PAT as a system for
Designing analyzing and controlling
manufacturing through timely measurements of
critical quality and performance attributes of
raw and in process materials and processes with
the goal of ensuring final product quality.
• Pat allows real-time monitoring of CMA CPP or
CQA
-Pratik Terse
16

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QbD Approach to Pharmaceutical Quality

  • 1. QUALITY BY DESIGN -Pratik Terse 1 Definition • According to ICH Q8 guideline, Quality by Design (QbD) is A systematic approach to development that begins with predefined objectives and emphasizes product & process understanding & process control, based on sound science & quality risk management.
  • 2. -Pratik Terse 2 Characteristics of QbD: • Tool for focusing on efficient drug development • Dynamic & systematic process • Relies on the concept that Quality can be build • Applicable to drug development • Applicable to analytical methods • Can implemented partially or totally • Can be used at any time in drug life cycle • Always encouraged by regulators
  • 3. QUALITY BY DESIGN • Eliminate batch failures • Minimize Deviations & Costly investigation • Avoid regulatory compliance problems • Empowerment of technical staff • Efficient, quick, flexible system • Ensure consistent information • Incorporate risk management • Reduced end product testing Advantages of QbD: -Pratik Terse 3
  • 4. QUALITY BY DESIGN Elements of QbD: • Quality Target Product Profile (QTPP) • Critical Quality Attributes (CQA) • Quality Risk Assessment (QRA) • Critical Process Parameters • Design Space • Control Strategy -Pratik Terse 4
  • 5. QUALITY BY DESIGN Quality Target Product Profile (QTPP): • According to ICH Q8(R2), QTTP is “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”. • Basically it is a tool for setting the strategy for drug development. • Recently QTTP is widely used in development planning, clinical and commercial decision making, regulatory agency interactions, and risk management. • It is the quality characteristics that the drug product should possess in order to reproducibly deliver the therapeutic benefit promised in the label. • The QTTP guides formulation scientists to establish formulation strategies and keep the formulation effort focused and efficient. • QTPP is related to identity, assay, dosage form, purity, stability in the label. -Pratik Terse 5
  • 6. QUALITY BY DESIGN Critical Quality Attributes (CQA): • Once QTPP has been identified, the next step is to identify the relevant CQAs. • A CQA is defined as “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 raw materials (drug substance, excipients), intermediates (inprocess materials), and drug product. • Drug product CQAs are the properties that are important for product performance, that is, the desired quality, safety, and efficacy -Pratik Terse 6
  • 7. QUALITY BY DESIGN Quality Risk Assessment (QRA) • The FDA defines a Risk Management as, a strategic safety program designed to decrease product risk by using one or more interventions or tools. • It is systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle • The ICH Q9 guideline: Quality Risk Management provides a structure to initiate and follow a risk management process. The relevant tools of QRM are as follows: • Failure mode effects analysis (FMEA) • Failure Mode, Effects and Criticality Analysis (FMECA) • Fault tree analysis (FTA) • Hazard analysis and critical control points (HACCP) -Pratik Terse 7
  • 8. QUALITY BY DESIGN Critical Process Parameters • A critical process parameter (CPP) is any measurable input (input material attribute or operating parameter) or output (process state variable or output material attribute) of a process step that must be controlled to achieve the desired product quality and process consistency. • A parameter is critical when a realistic change in that parameter can cause the product to fail to meet the QTPP. • Thus, whether a parameter is critical or not depends on how large of a change one is willing to consider. • Thus the first step in classifying parameters is to define the range of interest which we call the potential operating space (POS). • The POS is the region between the maximum and minimum value of interest for each process parameter -Pratik Terse 8
  • 9. QUALITY BY DESIGN Design Space: • ICH Q8(R2) defines design space as the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. • Working within the design space is not considered as a change. • Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. • Design space is proposed by the applicant and is subject to regulatory assessment and approval. -Pratik Terse 9
  • 10. QUALITY BY DESIGN Control Strategy: • ICH Q10 defines a control strategy as a planned set of controls derived from current product and process understanding that assures process performance and product quality. • The controls can include parameters and attributes related to: • Drug substance • Drug product materials and components, • Facility and equipment operating conditions • In process controls, finished product specifications • The associated methods and frequency of monitoring and control. -Pratik Terse 10
  • 11. -Pratik Terse 11 Tools of QbD: Prior Knowledge Risk Assessment Design of Experiment Process Analytical Technology (PAT)
  • 12. -Pratik Terse 12 Prior Knowledge: • As per ICH guidelines prior knowledge is the information or knowledge or skills that have been acquired through previous experience of similar processes and published information. • This tool can be used at the beginning of the developmental process and may be regularly updated using data generated during the process.
  • 13. -Pratik Terse 13 Risk assessment • Risk assessment is the process of understanding risk and mitigate it through appropriate and robust control. • It consists of the identification of Hazards and the evaluation of risk associated with exposure to those hazards. • There are further three components of risk assessment. • Risk identification : The systematic use of information to identify potential sources of hazards that are referring to the risk question or problem description, which can include historical data theoretical analysis. • Risk analysis: Estimation of the risk associated with the identified hazards. • Risk evaluation: The comparison of the estimated risk of given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.
  • 14. -Pratik Terse 14 Design of experiment • This tool involves setting up a series of structured test where changes to the variables of a process are made in planned manner. • Then the impact of these changes on chosen output is assess. • This tool is very effective in identifying all the factors that together impact the output responses.
  • 15. -Pratik Terse 15 Process analytical technology (PAT) • The US FDA defines PAT as a system for Designing analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in process materials and processes with the goal of ensuring final product quality. • Pat allows real-time monitoring of CMA CPP or CQA