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Quality by design
Prepared by:
Charmi Shah
(2308212170009)
M. pharm 1stsem
Guided by:
Dr. Zanza Patel
Assistant professor of
Parul Institute of
pharmacy
FACULTY OF PHARMACY
PARUL INSTITUTE OF PHARMACY
LIMDA, VADODARA
Content
Introduction
Aim and Goals of QbD
Elements of Pharmaceutical Development
Regulatory Need
Case Study on QbD
References
2
Introduction[1]
• Pharmaceutical QbD is a systematic approach to development that begins
with predefined objectives and emphasizes product and process
understanding and control, based on sound science and quality risk
management.
• Quality by design is an approach that aims to ensure the quality of
medicines by employing statistical, analytical and risk-management
methodology in the design, development and manufacturing of
medicines.
3
Background[2]
• 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.
4
QbD follows ICH guidelines:
ICH Q8 Pharmaceutical Development
ICH Q9 Quality Risk Management
ICH Q10 Quality System
5
Aim and Goals of QbD [3]
• A more systematic approach to development (also defined as quality by
design) can include, incorporation of prior knowledge, use of quality
risk management, and use of knowledge management throughout the
lifecycle.
1.To increase process capability and reduce product variability and
defects by enhancing product and process design, understanding, and
control.
2.To increase product development and manufacturing efficiencies.
3.To enhance root cause analysis and post approval change management.
6
Comparison between Traditional and Developed approach
7
Elements of Pharmaceutical Development
Quality Target Product Profile (QTPP)
Critical Quality Attribute (CQA)
Risk Assessment
Design Space
Control Strategy
Product Lifecycle Management and Continual Improvement
8
Quality Target Product Profile (QTPP)
• QTPP is a prospective summary of the quality characteristics of a drug product that
ideally will be achieved to ensure the desired quality, taking into account the safety
and efficacy of the drug product. Considerations in the QTPP could include:
• Route of administration, dosage form, and delivery system(s).
• Dosage strength(s) and Container closure system.
• Therapeutic moiety release or delivery and attributes affecting pharmacokinetic
characteristics (dissolution) appropriate to the drug product dosage form being
developed.
• Drug product quality criteria (e.g., sterility, purity, stability, and drug release)
appropriate for the intended marketed product.
9
Critical Quality Attribute
• 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.
10
Risk Assessment
• 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.
• Risk assessment is typically performed early in the pharmaceutical development
process and is repeated as more information becomes available and greater
knowledge is obtained.
• Risk assessment tools can be used to identify and rank parameters (e.g. equipment,
input materials) with potential to have an impact on product quality.
11
Example of using a Risk Assessment tool.
• For example, a team of experts could work together to develop an Ishikawa
(fishbone) diagram that identifies potential variables which can have an impact on
the desired quality attribute.
• The team could then rank the variables based on probability and severity using
failure mode effects analysis (FMEA) or similar tools based on prior knowledge
and experimental data.
• Here’s a representation of Ishikawa diagram for the Tablet.
12
Ishikawa diagram
13
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.
• The multi-dimensional region which encompasses the various combinations of
product design, manufacturing process, manufacturing process operating
parameters and raw material quality which ultimately results in quality product.
14
Design Space
• Working within the design space is not considered as a change, rather moving out
of design space is counted as a change and would initiate regulatory post approval
change process.
• The applicant can choose to establish independent design spaces for one or more
unit operations, or to establish a single design space that spans multiple
operations. While a separate design space for each unit operation is often simpler
to develop, a design space that spans the entire process can provide more
operational flexibility.
• For example, in the case of a drug product that undergoes degradation in solution
before lyophilization, the design space to control the extent of degradation (e.g.,
concentration, time, temperature) could be expressed.
15
Control Strategy
• A control strategy is designed to ensure that a product of required quality will be
produced consistently.
• The controls should be based on product, formulation and process understanding
and should include, at a minimum, control of the critical process parameters and
material attributes.
• Sources of variability that can impact product quality should be identified,
appropriately understood, and subsequently controlled.
• A control strategy can include:
• Control of input material attributes (e.g., drug substance, excipients, primary
packaging materials) based on an understanding of their impact on processability
or product quality; Product specification, a monitoring program (e.g., full product
testing at regular intervals).
16
Continual Improvement[4]
• Product quality can be improved throughout the product lifecycle; companies have
opportunities to opt inventive approaches to improve quality.
• Periodic maintenance can be done within a company’s own internal quality
system; but design space should be unchanged.
• The QbD approach avails the continuous improvement throughout products’ life
cycle this is distinguishing point from the conventional method.
17
QbD Tools[5]
18
Design of Experiment
DOE
• This tool identifies factors that influence a process or product response that pose a high risk. A
systematic approach through carefully planned experiments or studies.
Process Analytical Technology
PAT
• It is a framework for designing, analyzing and controlling pharmaceutical manufacturing process
through the measurement of Process Parameters which affect the Critical Quality Attribute.
Assessment
Risk Assessment
• Identification of the hazards and analysis and evaluation of risk.
DOE in simplified way
19
Regulatory Need: - Regulatory challenges and inspection[6]
During pre-license or preapproval inspections under a QbD concept, the FDA
inspection team will assess the implementation and effectiveness of the process
design as described in the application and whether knowledge and risk management
have been transferred successfully from development to manufacturing.
The inspection will evaluate the quality system and its effectiveness regarding
consistent product quality, change in control procedures, process improvements,
deviation management, and knowledge and risk management during the product
lifecycle.
20
Case Study on QbD [7]
• Development of the arzoxifene hydrochloride drug substance manufacturing
process, first via a traditional approach and subsequently via an enhanced
approach as QbD.
• The primary focus of this paper is to illustrate the impact and advantages of QbD
on the impurity control strategy.
• By operating the process at the extremes during design space studies, a larger
collection of organic impurities and higher levels of typical impurities are
observed in the intermediates.
21
Cont….
The process was, when
each of the synthetic
steps are operated
within the design space
the byproduct impurities
in the intermediates will
not exceed levels found
to be rejected in
subsequent steps
ensuring that the drug
substance will meet its
critical quality
attributes.
22
Cont….
Drug substance critical quality
attribute
Rationale
Identity Ensures drug product performance
Potency Ensures drug product safety
Purity Ensures drug product safety and efficacy
Particle size distribution It controls dissolution kinetics of the
molecule.
23
Cont….
Through the rigorous application of an
enhanced process development approach,
they have designed quality into the
arzoxifene hydrochloride drug substance.
24
Merck and Co’s Januvia (US) in 2006
• The first company who got the FDA approved products by
using QbD
25
QbD Assessment in Japan [7]
2007 2008 2009 2010 2011 2012 2013 2014 2015
0 3 3 2 11 11 12 27 16
26
0
5
10
15
20
25
30
2007 2008 2009 2010 2011 2012 2013 2014 2015
Number of approved products
So why QbD approach is
Important?
27
• Provides a higher level of quality assurance
• Facilitates regulatory assessment
• Systematic development described in regulatory submissions will
improve the regulatory assessment
• Improves the efficiency of the assessment / inspection
• Enables science and risk based regulatory decisions
• Provides more operational flexibility
• Facilitates innovation
• Improves communication between Regulators and Industry
28
To sum up…..
29
References
1. Introduction: Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J.
Pharmaceutical product development: A quality by design approach.
International journal of pharmaceutical investigation. 2016 Jul;6(3):129.
2. Background: Juran JM. Juran on quality by design: the new steps for planning
quality into goods and services. Simon and Schuster; 1992 May 4.
3. Aims and Goals: U. S. Food and Drug Administration. Guidance for Industry:
Q8 (2) Pharmaceutical Development. 2009. (Link:
https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf)
4. Continual improvement: Phil B., Phil N., marion C., Duncan T., Keith T., 2007.
Pharma Technol. Available on http://www.pharmtech.com/pharmtech/ Peer-
Reviewed+Research/The-Application-of-Quality-by-Designto-
Analytical/ArticleStandard/Article/detail/463580
30
References
5. Quality by Design, BySaket Yeotikar
6. Regulatory Need: Anastasia GL, Anurag SR. Regulatory challenges in
the QbD paradigm. Bio. Pharm. Int. 2012;25(9):44-53.
7. Case study and Importance from: - https://www.allfordrugs.com/qbd-
case-studies/
31
32

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Quality by design.. ppt for RA (1ST SEM

  • 1. Quality by design Prepared by: Charmi Shah (2308212170009) M. pharm 1stsem Guided by: Dr. Zanza Patel Assistant professor of Parul Institute of pharmacy FACULTY OF PHARMACY PARUL INSTITUTE OF PHARMACY LIMDA, VADODARA
  • 2. Content Introduction Aim and Goals of QbD Elements of Pharmaceutical Development Regulatory Need Case Study on QbD References 2
  • 3. Introduction[1] • Pharmaceutical QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and control, based on sound science and quality risk management. • Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines. 3
  • 4. Background[2] • 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. 4
  • 5. QbD follows ICH guidelines: ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Quality System 5
  • 6. Aim and Goals of QbD [3] • A more systematic approach to development (also defined as quality by design) can include, incorporation of prior knowledge, use of quality risk management, and use of knowledge management throughout the lifecycle. 1.To increase process capability and reduce product variability and defects by enhancing product and process design, understanding, and control. 2.To increase product development and manufacturing efficiencies. 3.To enhance root cause analysis and post approval change management. 6
  • 7. Comparison between Traditional and Developed approach 7
  • 8. Elements of Pharmaceutical Development Quality Target Product Profile (QTPP) Critical Quality Attribute (CQA) Risk Assessment Design Space Control Strategy Product Lifecycle Management and Continual Improvement 8
  • 9. Quality Target Product Profile (QTPP) • QTPP is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account the safety and efficacy of the drug product. Considerations in the QTPP could include: • Route of administration, dosage form, and delivery system(s). • Dosage strength(s) and Container closure system. • Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics (dissolution) appropriate to the drug product dosage form being developed. • Drug product quality criteria (e.g., sterility, purity, stability, and drug release) appropriate for the intended marketed product. 9
  • 10. Critical Quality Attribute • 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. 10
  • 11. Risk Assessment • 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. • Risk assessment is typically performed early in the pharmaceutical development process and is repeated as more information becomes available and greater knowledge is obtained. • Risk assessment tools can be used to identify and rank parameters (e.g. equipment, input materials) with potential to have an impact on product quality. 11
  • 12. Example of using a Risk Assessment tool. • For example, a team of experts could work together to develop an Ishikawa (fishbone) diagram that identifies potential variables which can have an impact on the desired quality attribute. • The team could then rank the variables based on probability and severity using failure mode effects analysis (FMEA) or similar tools based on prior knowledge and experimental data. • Here’s a representation of Ishikawa diagram for the Tablet. 12
  • 14. 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. • The multi-dimensional region which encompasses the various combinations of product design, manufacturing process, manufacturing process operating parameters and raw material quality which ultimately results in quality product. 14
  • 15. Design Space • Working within the design space is not considered as a change, rather moving out of design space is counted as a change and would initiate regulatory post approval change process. • The applicant can choose to establish independent design spaces for one or more unit operations, or to establish a single design space that spans multiple operations. While a separate design space for each unit operation is often simpler to develop, a design space that spans the entire process can provide more operational flexibility. • For example, in the case of a drug product that undergoes degradation in solution before lyophilization, the design space to control the extent of degradation (e.g., concentration, time, temperature) could be expressed. 15
  • 16. Control Strategy • A control strategy is designed to ensure that a product of required quality will be produced consistently. • The controls should be based on product, formulation and process understanding and should include, at a minimum, control of the critical process parameters and material attributes. • Sources of variability that can impact product quality should be identified, appropriately understood, and subsequently controlled. • A control strategy can include: • Control of input material attributes (e.g., drug substance, excipients, primary packaging materials) based on an understanding of their impact on processability or product quality; Product specification, a monitoring program (e.g., full product testing at regular intervals). 16
  • 17. Continual Improvement[4] • Product quality can be improved throughout the product lifecycle; companies have opportunities to opt inventive approaches to improve quality. • Periodic maintenance can be done within a company’s own internal quality system; but design space should be unchanged. • The QbD approach avails the continuous improvement throughout products’ life cycle this is distinguishing point from the conventional method. 17
  • 18. QbD Tools[5] 18 Design of Experiment DOE • This tool identifies factors that influence a process or product response that pose a high risk. A systematic approach through carefully planned experiments or studies. Process Analytical Technology PAT • It is a framework for designing, analyzing and controlling pharmaceutical manufacturing process through the measurement of Process Parameters which affect the Critical Quality Attribute. Assessment Risk Assessment • Identification of the hazards and analysis and evaluation of risk.
  • 20. Regulatory Need: - Regulatory challenges and inspection[6] During pre-license or preapproval inspections under a QbD concept, the FDA inspection team will assess the implementation and effectiveness of the process design as described in the application and whether knowledge and risk management have been transferred successfully from development to manufacturing. The inspection will evaluate the quality system and its effectiveness regarding consistent product quality, change in control procedures, process improvements, deviation management, and knowledge and risk management during the product lifecycle. 20
  • 21. Case Study on QbD [7] • Development of the arzoxifene hydrochloride drug substance manufacturing process, first via a traditional approach and subsequently via an enhanced approach as QbD. • The primary focus of this paper is to illustrate the impact and advantages of QbD on the impurity control strategy. • By operating the process at the extremes during design space studies, a larger collection of organic impurities and higher levels of typical impurities are observed in the intermediates. 21
  • 22. Cont…. The process was, when each of the synthetic steps are operated within the design space the byproduct impurities in the intermediates will not exceed levels found to be rejected in subsequent steps ensuring that the drug substance will meet its critical quality attributes. 22
  • 23. Cont…. Drug substance critical quality attribute Rationale Identity Ensures drug product performance Potency Ensures drug product safety Purity Ensures drug product safety and efficacy Particle size distribution It controls dissolution kinetics of the molecule. 23
  • 24. Cont…. Through the rigorous application of an enhanced process development approach, they have designed quality into the arzoxifene hydrochloride drug substance. 24
  • 25. Merck and Co’s Januvia (US) in 2006 • The first company who got the FDA approved products by using QbD 25
  • 26. QbD Assessment in Japan [7] 2007 2008 2009 2010 2011 2012 2013 2014 2015 0 3 3 2 11 11 12 27 16 26 0 5 10 15 20 25 30 2007 2008 2009 2010 2011 2012 2013 2014 2015 Number of approved products
  • 27. So why QbD approach is Important? 27
  • 28. • Provides a higher level of quality assurance • Facilitates regulatory assessment • Systematic development described in regulatory submissions will improve the regulatory assessment • Improves the efficiency of the assessment / inspection • Enables science and risk based regulatory decisions • Provides more operational flexibility • Facilitates innovation • Improves communication between Regulators and Industry 28
  • 30. References 1. Introduction: Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J. Pharmaceutical product development: A quality by design approach. International journal of pharmaceutical investigation. 2016 Jul;6(3):129. 2. Background: Juran JM. Juran on quality by design: the new steps for planning quality into goods and services. Simon and Schuster; 1992 May 4. 3. Aims and Goals: U. S. Food and Drug Administration. Guidance for Industry: Q8 (2) Pharmaceutical Development. 2009. (Link: https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf) 4. Continual improvement: Phil B., Phil N., marion C., Duncan T., Keith T., 2007. Pharma Technol. Available on http://www.pharmtech.com/pharmtech/ Peer- Reviewed+Research/The-Application-of-Quality-by-Designto- Analytical/ArticleStandard/Article/detail/463580 30
  • 31. References 5. Quality by Design, BySaket Yeotikar 6. Regulatory Need: Anastasia GL, Anurag SR. Regulatory challenges in the QbD paradigm. Bio. Pharm. Int. 2012;25(9):44-53. 7. Case study and Importance from: - https://www.allfordrugs.com/qbd- case-studies/ 31
  • 32. 32