The document discusses key concepts of Quality by Design (QbD) in pharmaceutical product development:
- QbD is a systematic approach that emphasizes product and process understanding through predefined objectives and quality risk management.
- It involves identifying critical quality attributes, understanding how material attributes and process parameters affect them, and using this knowledge to design a control strategy and establish a design space.
- The control strategy ensures consistent product quality by controlling critical process parameters and material attributes based on formulation and process understanding. It can include alternative approaches like real-time release testing.
This document discusses Quality by Design (QbD) and its role in pharmaceutical product development. QbD aims to ensure product quality through scientific development and risk management tools. Key aspects of QbD include defining quality target product profiles, identifying critical quality attributes and critical process parameters, and using this information to establish a design space for manufacturing. The document provides examples of how QbD has been applied in various pharmaceutical development and manufacturing case studies.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
Quality by design (QbD) is a systematic approach to drug development that emphasizes product and process understanding based on science and risk management. It was introduced by the FDA to modernize chemistry, manufacturing, and control for biologics, pharmaceuticals, and vaccines. QbD has now become mandatory for drug submissions. The key principles of QbD include clear definition of product requirements, use of quality risk management in all development aspects, enhanced product and process understanding, improved specifications and control strategies using modern technologies like process analytical technologies. QbD aims to design high quality products and manufacturing processes to consistently deliver intended performance.
The Pharmaceutical Quality by Design is 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.
Quality cannot be tested into products; it has to be built in by design.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science. The main objectives of QbD are to ensure quality products by combining prior knowledge with new data to identify critical quality attributes and critical process parameters, and establish a control strategy within a design space. This approach helps provide a better understanding of processes and fewer batch failures through improved control and management of changes over the product lifecycle.
The document provides an overview of Quality by Design (QbD) in the pharmaceutical industry. It discusses key concepts like defining objectives, determining critical quality attributes, risk assessment, experimental design, control strategies, and continuous improvement. A case study is presented on developing naproxen enteric-coated pellets using a QbD approach including failure mode and effects analysis, Plackett-Burman design, and Box-Behnken design to establish a design space meeting quality criteria. The document serves to introduce QbD principles and how they were applied in a specific drug development example.
This document discusses Quality by Design (QbD) and its role in pharmaceutical product development. QbD aims to ensure product quality through scientific development and risk management tools. Key aspects of QbD include defining quality target product profiles, identifying critical quality attributes and critical process parameters, and using this information to establish a design space for manufacturing. The document provides examples of how QbD has been applied in various pharmaceutical development and manufacturing case studies.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
Quality by design (QbD) is a systematic approach to drug development that emphasizes product and process understanding based on science and risk management. It was introduced by the FDA to modernize chemistry, manufacturing, and control for biologics, pharmaceuticals, and vaccines. QbD has now become mandatory for drug submissions. The key principles of QbD include clear definition of product requirements, use of quality risk management in all development aspects, enhanced product and process understanding, improved specifications and control strategies using modern technologies like process analytical technologies. QbD aims to design high quality products and manufacturing processes to consistently deliver intended performance.
The Pharmaceutical Quality by Design is 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.
Quality cannot be tested into products; it has to be built in by design.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science. The main objectives of QbD are to ensure quality products by combining prior knowledge with new data to identify critical quality attributes and critical process parameters, and establish a control strategy within a design space. This approach helps provide a better understanding of processes and fewer batch failures through improved control and management of changes over the product lifecycle.
The document provides an overview of Quality by Design (QbD) in the pharmaceutical industry. It discusses key concepts like defining objectives, determining critical quality attributes, risk assessment, experimental design, control strategies, and continuous improvement. A case study is presented on developing naproxen enteric-coated pellets using a QbD approach including failure mode and effects analysis, Plackett-Burman design, and Box-Behnken design to establish a design space meeting quality criteria. The document serves to introduce QbD principles and how they were applied in a specific drug development example.
The document discusses Quality by Design (QbD) in the pharmaceutical industry. It defines QbD and outlines its key benefits, including higher product quality assurance, cost savings, and regulatory flexibility. The main elements of QbD are described as identifying target quality profiles, critical quality attributes, risk assessment, linking attributes and parameters to quality, defining a design space and control strategy. QbD facilitates innovation and continuous improvement across a product's lifecycle.
DEFINITION,PRINCIPLE, OBJECTIVES, ELEMENTS AND TOOLS OF QUALITY BY DESIGN (Qb...Durgadevi Ganesan
Quality by Design is a concept first outlined by Joseph M. Juran in various publications. He supposed that quality could be planned. The concept of QBD was mention in ICH Q8 guidelines, which states that, “To identify quality can not be tested in products, i.e. Quality should be built in to product by design.”
What is Quality by Design (QbD)?
Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Why QbD?
Principle of QbD
Objectives of QbD
ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN:
- Quality Target Product Profile
- Critical Quality Attributes
- Product Design and Understanding
- Process Design and Understanding
- Process Design and Understanding
- Design space
- Control Strategy
- Continual Improvement
DESIGN TOOLS
- Prior Knowledge
- Risk Assessment
- Mechanistic Model, Design of Experiments, and Data Analysis
- Process Analytical Technology
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )DhrutiPatel61
This document provides an overview of pharmaceutical development and quality by design principles. It discusses developing a quality target product profile, identifying critical quality attributes and material/process parameters. The document describes formulation development, manufacturing process development, process controls and continual improvement over a product's lifecycle according to ICH Q8, Q9 and Q10 guidelines. The goal is to build quality into products from the beginning and ensure quality through appropriate controls and risk management approaches.
This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
The document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses key QbD concepts like defining a quality target product profile, identifying critical quality attributes and critical material attributes, designing quality into the product through development strategies like design of experiments, and establishing a design space and control strategy. The document outlines the important steps and aspects of a QbD-based pharmaceutical development process from formulation to manufacturing. It emphasizes gaining process understanding, building quality into the product, and taking a systematic risk-based approach.
The document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding. It discusses the key steps in a QbD approach: 1) defining a target product profile, 2) determining critical quality attributes, 3) linking materials attributes and process parameters to critical quality attributes, 4) defining a design space, 5) establishing a control strategy, and 6) product lifecycle management and continual improvement. The presentation also covers how QbD impacts companies, universities, and health authorities.
This document discusses quality by design (QbD) in pharmaceutical development. It begins with introducing QbD as a systematic approach to development that emphasizes product and process understanding based on science and risk management. The key elements of QbD discussed include establishing a quality target product profile, identifying critical quality attributes, conducting risk assessments, defining a design space and control strategy, and enabling continual improvement. A case study demonstrates how QbD improved impurity control for a drug substance. Overall, the document provides an overview of the principles and tools of QbD and its benefits for ensuring quality and facilitating regulatory assessment and flexibility.
REGULATORY AND INDUSTRY ASPECT OF QUALITY BY DESIGN.pptxSumant Saini
Quality by Design (QbD) involves a thorough understanding of the manufacturing process, defining goals before starting process development, and establishing a design space and risk assessment strategy. Regulatory agencies like the FDA support QbD and have provided guidelines through ICH Q8, Q9, and Q10. Under QbD, the regulatory burden is reduced because wider process ranges and limits not requiring prior approval can be established through product and process understanding. FDA inspections of QbD processes will evaluate implementation and knowledge transfer from development to manufacturing, as well as the quality system's effectiveness in maintaining consistent quality over the product lifecycle.
The document discusses Quality by Design (QbD) in pharmaceutical manufacturing. It defines QbD as a systematic approach to development that emphasizes product and process understanding through design and control based on science and risk management. The key goals of QbD are to develop quality products based on clinical performance, increase process capability, and enhance manufacturing efficiencies. QbD involves defining quality targets, understanding critical materials and processes, and establishing a control strategy to consistently meet quality standards.
This document summarizes a research article about Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. Some key points:
1) QbD aims to develop robust processes to consistently deliver quality products by understanding critical quality attributes and controlling variables throughout the product lifecycle.
2) International guidelines like ICH Q8, Q9, and Q10 provide a framework for QbD implementation and its benefits like reduced regulatory oversight and manufacturing flexibility.
3) The QbD approach involves defining a quality target product profile, identifying critical quality attributes, understanding material and process impacts through risk assessment, and implementing a control strategy within
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...Bachu Sreekanth
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. It aims to enhance drug quality and supply to consumers. The QbD process involves gathering prior knowledge, designing formulations and processes, identifying critical quality attributes, establishing control strategies, and continually monitoring and improving processes. QbD provides benefits like reduced batch failures, more efficient control of changes, and opportunities for more flexible regulatory approaches.
This presentation introduces Quality by Design (QbD) for pharmaceutical formulation and development. QbD requires understanding how formulation and process variables impact product quality to ensure predefined quality. The benefits of QbD include eliminating batch failures, minimizing deviations, and avoiding regulatory issues. For formulation and development, QbD involves establishing a quality target product profile, identifying critical quality attributes, conducting a risk assessment of drug substance and formulation attributes, developing an initial formulation, using design of experiments for optimization, establishing a control strategy, conducting pilot bioequivalence studies, and scale up with supporting stability studies.
This document provides an overview of Quality by Design (QbD), including its background and definition. It discusses the FDA's initiative on QbD and why the QbD approach is used. Key quality guidance documents such as ICH Q8, Q8(R1), Q9, and Q10 are summarized. The document compares the current and QbD approaches to pharmaceutical development and provides an example of a QbD approach. It also describes several tools used in QbD like design space, design of experiments, quality risk management, and process analytical technology.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management. Key aspects of QbD include establishing a Quality Target Product Profile (QTPP) that identifies critical quality attributes (CQAs), understanding critical material attributes (CMAs) and critical process parameters (CPPs), and implementing a control strategy for CQAs and CPPs. The ICH Q8 guideline introduced QbD, and it has been further developed through guidelines like ICH Q9 and Q10. Examples show how QbD has been applied scientifically in different pharmaceutical development and manufacturing processes.
The document describes key concepts from ICH Q8 guidelines on pharmaceutical development, including defining a quality target product profile, identifying critical quality attributes, using risk assessment to link material and process attributes to critical quality attributes, establishing a design space, implementing a control strategy, and continually improving the product over its lifecycle. The guidelines provide a framework for a quality by design approach to pharmaceutical development and manufacturing.
The pharmaceutical Quality by Design is 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. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance
This document introduces the key concepts of Quality by Design (QbD), including:
1) QbD ensures product quality is built in from the beginning through understanding how formulation and manufacturing processes impact quality.
2) Critical Quality Attributes and Critical Process Parameters are identified based on a Target Product Quality Profile to ensure desired product quality.
3) Risk assessment determines which factors most influence quality and a design space is established where quality can be assured.
4) A control strategy is developed to evaluate and ensure quality through all stages of development and manufacturing.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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The document discusses Quality by Design (QbD) in the pharmaceutical industry. It defines QbD and outlines its key benefits, including higher product quality assurance, cost savings, and regulatory flexibility. The main elements of QbD are described as identifying target quality profiles, critical quality attributes, risk assessment, linking attributes and parameters to quality, defining a design space and control strategy. QbD facilitates innovation and continuous improvement across a product's lifecycle.
DEFINITION,PRINCIPLE, OBJECTIVES, ELEMENTS AND TOOLS OF QUALITY BY DESIGN (Qb...Durgadevi Ganesan
Quality by Design is a concept first outlined by Joseph M. Juran in various publications. He supposed that quality could be planned. The concept of QBD was mention in ICH Q8 guidelines, which states that, “To identify quality can not be tested in products, i.e. Quality should be built in to product by design.”
What is Quality by Design (QbD)?
Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Why QbD?
Principle of QbD
Objectives of QbD
ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN:
- Quality Target Product Profile
- Critical Quality Attributes
- Product Design and Understanding
- Process Design and Understanding
- Process Design and Understanding
- Design space
- Control Strategy
- Continual Improvement
DESIGN TOOLS
- Prior Knowledge
- Risk Assessment
- Mechanistic Model, Design of Experiments, and Data Analysis
- Process Analytical Technology
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )DhrutiPatel61
This document provides an overview of pharmaceutical development and quality by design principles. It discusses developing a quality target product profile, identifying critical quality attributes and material/process parameters. The document describes formulation development, manufacturing process development, process controls and continual improvement over a product's lifecycle according to ICH Q8, Q9 and Q10 guidelines. The goal is to build quality into products from the beginning and ensure quality through appropriate controls and risk management approaches.
This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
The document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses key QbD concepts like defining a quality target product profile, identifying critical quality attributes and critical material attributes, designing quality into the product through development strategies like design of experiments, and establishing a design space and control strategy. The document outlines the important steps and aspects of a QbD-based pharmaceutical development process from formulation to manufacturing. It emphasizes gaining process understanding, building quality into the product, and taking a systematic risk-based approach.
The document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding. It discusses the key steps in a QbD approach: 1) defining a target product profile, 2) determining critical quality attributes, 3) linking materials attributes and process parameters to critical quality attributes, 4) defining a design space, 5) establishing a control strategy, and 6) product lifecycle management and continual improvement. The presentation also covers how QbD impacts companies, universities, and health authorities.
This document discusses quality by design (QbD) in pharmaceutical development. It begins with introducing QbD as a systematic approach to development that emphasizes product and process understanding based on science and risk management. The key elements of QbD discussed include establishing a quality target product profile, identifying critical quality attributes, conducting risk assessments, defining a design space and control strategy, and enabling continual improvement. A case study demonstrates how QbD improved impurity control for a drug substance. Overall, the document provides an overview of the principles and tools of QbD and its benefits for ensuring quality and facilitating regulatory assessment and flexibility.
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Quality by Design (QbD) involves a thorough understanding of the manufacturing process, defining goals before starting process development, and establishing a design space and risk assessment strategy. Regulatory agencies like the FDA support QbD and have provided guidelines through ICH Q8, Q9, and Q10. Under QbD, the regulatory burden is reduced because wider process ranges and limits not requiring prior approval can be established through product and process understanding. FDA inspections of QbD processes will evaluate implementation and knowledge transfer from development to manufacturing, as well as the quality system's effectiveness in maintaining consistent quality over the product lifecycle.
The document discusses Quality by Design (QbD) in pharmaceutical manufacturing. It defines QbD as a systematic approach to development that emphasizes product and process understanding through design and control based on science and risk management. The key goals of QbD are to develop quality products based on clinical performance, increase process capability, and enhance manufacturing efficiencies. QbD involves defining quality targets, understanding critical materials and processes, and establishing a control strategy to consistently meet quality standards.
This document summarizes a research article about Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. Some key points:
1) QbD aims to develop robust processes to consistently deliver quality products by understanding critical quality attributes and controlling variables throughout the product lifecycle.
2) International guidelines like ICH Q8, Q9, and Q10 provide a framework for QbD implementation and its benefits like reduced regulatory oversight and manufacturing flexibility.
3) The QbD approach involves defining a quality target product profile, identifying critical quality attributes, understanding material and process impacts through risk assessment, and implementing a control strategy within
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Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. It aims to enhance drug quality and supply to consumers. The QbD process involves gathering prior knowledge, designing formulations and processes, identifying critical quality attributes, establishing control strategies, and continually monitoring and improving processes. QbD provides benefits like reduced batch failures, more efficient control of changes, and opportunities for more flexible regulatory approaches.
This presentation introduces Quality by Design (QbD) for pharmaceutical formulation and development. QbD requires understanding how formulation and process variables impact product quality to ensure predefined quality. The benefits of QbD include eliminating batch failures, minimizing deviations, and avoiding regulatory issues. For formulation and development, QbD involves establishing a quality target product profile, identifying critical quality attributes, conducting a risk assessment of drug substance and formulation attributes, developing an initial formulation, using design of experiments for optimization, establishing a control strategy, conducting pilot bioequivalence studies, and scale up with supporting stability studies.
This document provides an overview of Quality by Design (QbD), including its background and definition. It discusses the FDA's initiative on QbD and why the QbD approach is used. Key quality guidance documents such as ICH Q8, Q8(R1), Q9, and Q10 are summarized. The document compares the current and QbD approaches to pharmaceutical development and provides an example of a QbD approach. It also describes several tools used in QbD like design space, design of experiments, quality risk management, and process analytical technology.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management. Key aspects of QbD include establishing a Quality Target Product Profile (QTPP) that identifies critical quality attributes (CQAs), understanding critical material attributes (CMAs) and critical process parameters (CPPs), and implementing a control strategy for CQAs and CPPs. The ICH Q8 guideline introduced QbD, and it has been further developed through guidelines like ICH Q9 and Q10. Examples show how QbD has been applied scientifically in different pharmaceutical development and manufacturing processes.
The document describes key concepts from ICH Q8 guidelines on pharmaceutical development, including defining a quality target product profile, identifying critical quality attributes, using risk assessment to link material and process attributes to critical quality attributes, establishing a design space, implementing a control strategy, and continually improving the product over its lifecycle. The guidelines provide a framework for a quality by design approach to pharmaceutical development and manufacturing.
The pharmaceutical Quality by Design is 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. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance
This document introduces the key concepts of Quality by Design (QbD), including:
1) QbD ensures product quality is built in from the beginning through understanding how formulation and manufacturing processes impact quality.
2) Critical Quality Attributes and Critical Process Parameters are identified based on a Target Product Quality Profile to ensure desired product quality.
3) Risk assessment determines which factors most influence quality and a design space is established where quality can be assured.
4) A control strategy is developed to evaluate and ensure quality through all stages of development and manufacturing.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
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3. Definition
Pharmaceutical Development
Approaches to Pharmaceutical Development
Elements of Pharmaceutical development
Quality by Design
Outline
3
4. ICH Q8(R2)- Pharmaceutical Development
Pramod K., Tahir M.A., Charoo N.A., Ansari S.H., Ali J. (2016).
Pharmaceutical product development: A quality by design
approach. Int J Pharm Investig; 6(3): 129–138
Reference
4
5. ICH Q9- Quality Risk Management
ICH Q10- Pharmaceutical Quality System
ICH training materials
Reference
5
6. 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
Definition
6
7. Process Analytical Technology (PAT)
A system for designing, analyzing, and controlling manufacturing
through timely measurements (i.e., during processing) of critical
quality and performance attributes of raw and in-process materials
and processes with the goal of ensuring final product quality.
Definition
7
8. Design Space
The multidimensional combination and interaction of input variables
(e.g., material attributes) and process parameters that have been
demonstrated to provide assurance of quality.
Definition
8
9. Product lifecycle
All phases in the life of a product from the initial development
through marketing until the product’s discontinuation.
Process Robustness:
Ability of a process to tolerate variability of materials and changes of
the process and equipment without negative impact on quality.
Definition
9
10. Critical Process Parameter (CPP):
A process parameter whose variability has an impact on a critical
quality attribute and therefore should be monitored or controlled to
ensure the process produces the desired quality.
Definition
10
11. Provides an opportunity to present the knowledge gained through the
application of scientific approaches and quality risk management to the
development of a product and its manufacturing process.
Create a basis of flexible regulatory approaches by reducing uncertainty
Facilitate risk based regulatory decisions
Continuous improvements without the need for regulatory review
”real time” quality assurance
ICH Q8: Pharmaceutical development
11
12. The aim of pharmaceutical development is to design a quality product
and its manufacturing process to consistently deliver the intended
performance of the product.
The information and knowledge gained from pharmaceutical
development studies and manufacturing experience provide scientific
understanding to support the establishment of the design space,
specifications, and manufacturing controls.
ICH Q8: Pharmaceutical development
12
13. Pharmaceutical Development section of a dossier
is intended to provide a comprehensive understanding of the
product and manufacturing process for reviewers and inspectors
The degree of regulatory flexibility is predicated on the level of
relevant scientific knowledge provided
ICH Q8: Pharmaceutical development
13
14. Information from pharmaceutical development studies
can be a basis for quality risk management
important to recognize that quality cannot be tested into
products, i.e., quality should be built in by design
ICH Q8: Pharmaceutical development
14
15. Design space is proposed by the applicant and is subject to
regulatory assessment and approval.
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.
ICH Q8: Pharmaceutical development
15
16. The product should be designed to meet patients’ needs and the
intended product performance.
Strategies for product development vary from company to
company and from product to product.
The approach to, and extent of, development can also vary
Approaches to Pharmaceutical Development
16
17. An applicant might choose either
an empirical approach (Minimal approach)
a more systematic approach to product development (QbD)
a combination of both
(ICH Q8)
Approaches to Pharmaceutical Development
17
19. A more systematic approach to development (QbD) can include,
for example,
incorporation of prior knowledge
Results of studies using design of experiments
use of quality risk management
use of knowledge management (see ICH Q10) throughout the
lifecycle of the product.
Approaches to Pharmaceutical Development
19
20. A more systematic approach to development ( QbD)
can enhance achieving the desired quality of the product
help the regulators to better understand a company’s strategy
Product and process understanding can be updated with the
knowledge gained over the product lifecycle
Approaches to Pharmaceutical Development
20
21. Pharmaceutical development should include, at a minimum, the
following elements
Defining the quality target product profile (QTPP)
as it relates to quality, safety and efficacy, considering e.g., the route of
administration, dosage form, bioavailability, strength, and stability
Identifying potential critical quality attributes (CQAs) of the drug
product
so that those product characteristics having an impact on product quality can
be studied and controlled
Approaches to Pharmaceutical Development
21
22. Pharmaceutical development should include, at a minimum, the
following elements
Determining the critical quality attributes of the drug substance,
excipients etc., and selecting the type and amount of excipients to
deliver drug product of the desired quality
Selecting an appropriate manufacturing process
Defining a control strategy
Approaches to Pharmaceutical Development
22
23. A quality by design approach to product development would
additionally include the following elements:
A systematic evaluation, understanding and refining of the
formulation and manufacturing process, including;
Identifying, through e.g., prior knowledge, experimentation, and risk
assessment, the material attributes and process parameters that can have an
effect on product CQAs;
Determining the functional relationships that link material attributes and
process parameters to product CQAs;
Approaches to Pharmaceutical Development
23
24. Additional elements for QbD approach to product development …..
Using the enhanced product and process understanding in
combination with quality risk management to establish an
appropriate control strategy which can, for example, include a
proposal for a design space(s) and/or real-time release testing.
• This result, more systematic approach could facilitate continual
improvement and innovation throughout the product lifecycle (See
ICH Q10).
Approaches to Pharmaceutical Development
24
25. Forms the basis of design for the development of the product
Considerations for the QTPP could include
Intended use in clinical setting, route of administration, dosage form, delivery
systems;
Dosage strength(s);
Container closure system;
Elements of PD- Quality Target Product Profile (QTPP)
25
26. Considerations for the QTPP …..
Therapeutic moiety release or delivery and attributes affecting PK characteristics
(e.g., dissolution, aerodynamic performance) 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.
Elements of PD- Quality Target Product Profile (QTPP)
26
27. 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
CQAs of SODFs are typically those aspects affecting product purity, strength,
drug release and stability
Elements of PD- Critical Quality Attributes (CQA)
27
28. CQAs for other delivery systems can additionally include more
product specific aspects, such as
aerodynamic properties for inhaled products
sterility for parenterals
adhesion properties for transdermal patches
For drug substances, raw materials and intermediates, the CQAs can
additionally include those properties (e.g., particle size distribution,
bulk density) that affect drug product CQAs.
Elements of PD- Critical Quality Attributes (CQA)
28
29. Linking Material Attributes and Process Parameters to Drug
Product CQAs
Risk assessment
is a valuable science-based process used in quality risk management
(see ICH Q9)
aid in identifying which material attributes and process parameters
potentially have an effect on product CQAs.
Elements of PD-Risk Assessment
29
30. Risk assessment
Performed early in the PD 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., process, equipment, input materials) with
potential to have an impact on product quality
Elements of PD-Risk Assessment
30
31. The relationship b/n process inputs (material attributes and
process parameters) and the CQAs can be described in the
design space
This include an understanding of the linkage and effect of process
parameters and material attributes on product CQAs
Elements of PD-Design Space
31
32. Parameters needs to considered:
Selection of Variables
A description of the process parameters and material attributes
considered for the design space and their effect on product quality
Describing a Design Space in a Submission
A design space can be described in terms of ranges of material attributes
and process parameters, or through more complex mathematical
relationships.
Elements of PD-Design Space
32
33. Describing a Design Space in a Submission…
It is possible to describe a design space as a time dependent function
(e.g., temperature and pressure cycle of a lyophilisation cycle), or as a
combination of variables such as components of a multivariate model.
Analysis of historical data can contribute to the establishment of a design
space.
Elements of PD-Design Space
33
34. Unit Operation Design Space
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
For example, in the case of a drug product that undergoes degradation in
solution before lyophilisation, the design space to control the extent of
degradation (e.g., concentration, time, temperature) could be expressed
for each unit operation or as a sum over all unit operations.
Elements of PD-Design Space
34
35. Unit Operation Design Space
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
For example, in the case of a drug product that undergoes degradation in
solution before lyophilisation, the design space to control the extent of
degradation (e.g., concentration, time, temperature) could be expressed
for each unit operation or as a sum over all unit operations.
Design Space Versus Proven Acceptable Ranges
Elements of PD-Design Space
35
36. It begins with predefined
objectives and requires an
understanding how
formulation and process
variables influence
product quality
Quality by Design (QbD)
36
37. Involves a thorough understanding of the relationship of product
performance with product attribute and process
Involves the use of multivariate statistics and design of
experiments technique
Quality by Design (QbD)
37
38. Application of QbD approach in pharmaceutical product
development
is systematic, involving multivariate experiments utilizing process
analytical technology (PAT) and other tests to identify critical quality
attributes (CQAs) based on risk assessments (RAs)
can lead to robust formulations and high success rate in regulatory
approvals
Quality by Design (QbD)
38
39. Figure 1: depicts an
overall QbD system
where RA and risk
control for the product
and process are involved
Quality by Design (QbD)
39
41. The important components of product development by QbD
are
target product profile (TPP)
target product quality profile (TPQP)
design and development of product
developing the manufacturing process
identifying the CQA
Quality by Design (QbD)
41
42. The components of product development by QbD ….
assessment and management of the risks involved in the process
establishment of design space
defining a control strategy for a product to stay within the design
space.
Quality by Design (QbD)
42
43. Control strategy
A control strategy is designed to ensure that a product of required
quality will be produced consistently
The elements of the control strategy should describe and justify how
in-process controls and the controls of input materials (API &
excipients), intermediates, container closure system, and drug
products contribute to the final product quality
Quality by Design (QbD)
43
44. Control strategy
A control strategy is designed to ensure that a product of required
quality
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
Quality by Design (QbD)
44
45. Control strategy…
Process understanding can enable an alternative manufacturing
paradigm where the variability of input materials could be less tightly
constrained
o it can be possible to design an adaptive process step with appropriate process
control to ensure consistent product quality
Quality by Design (QbD)
45
46. Control strategy…
Enhanced understanding of product performance can justify the use
of alternative approaches to determine that the material is meeting
its quality attributes.
o The use of such alternatives could support real time release testing
o For example,
DT could serve as a surrogate for DS for fast-disintegrating solid forms with highly soluble drug
substances
Quality by Design (QbD)
46
47. Control strategy can include but not limited to
Control of input material attributes (e.g., API, excipients, primary packaging Ms)
Product specification(s)
Controls for unit operations that have an impact on downstream processing or
product quality
In-process or real-time release testing in lieu of end-product testing (e.g.
measurement and control of CQAs during processing)
A monitoring program (e.g., full product testing at regular intervals) for verifying
multivariate prediction models
Quality by Design (QbD)
47
48. Product Lifecycle Management and Continual Improvement
Provide an opportunity to evaluate innovative approaches to improve product
quality (see ICH Q10) through out product life cycle
Process performance can be monitored to ensure that it is working as anticipated to
deliver product quality attributes as predicted by the design space including
Trend analysis of the manufacturing process as additional experience is gained during routine
manufacture
Quality by Design (QbD)
48
49. Q8(R2) - Example QbD Approach
Quality Target Product Profile (QTPP)
Determine “potential” critical quality attributes (CQAs)
Link raw material attributes and process parameters to CQAs and
perform risk assessment
Develop a design space
Design and implement a control strategy
Manage product lifecycle, including continual improvement
Quality by Design (QbD)
49
Product profile
Continuous
improvement
CQA’s
Risk Assessment
Design Space
Control strategy