This document provides a review of Quality by Design (QbD) and its approaches in the pharmaceutical industry. It discusses that QbD is a systematic approach to development that begins with predetermined objectives and emphasizes understanding and controlling manufacturing processes based on science and risk management. The key benefits of QbD include eliminating batch failures, minimizing deviations, and increasing manufacturing efficiency. QbD involves defining a target quality profile, identifying critical quality attributes and process parameters, and establishing controls to ensure consistent quality. Elements of a QbD approach include product design, understanding material and process variables that influence quality, and controlling the manufacturing process.
This document summarizes a seminar presentation on Quality by Design (QbD). The presentation introduces QbD, discusses its key elements like Quality Target Product Profile, Critical Quality Attributes, risk assessment, design space, and control strategy. It provides examples of applying QbD principles to tablet manufacturing and using a QbD approach to study the downstream processing of hot-melt extrusion to tablet formation. The presentation concludes with key advantages of implementing a QbD system for pharmaceutical development and manufacturing.
Pharmaceutical QbD concepts for drug developmentGuru Balaji .S
The document discusses quality by design (QbD) in pharmaceutical development. It defines QbD as a systematic approach that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. Under QbD, the desired product performance profile, target product quality attributes, and critical material attributes are defined to identify and control sources of variability. QbD provides increased flexibility while maintaining quality standards compared to traditional quality testing approaches. Key aspects of implementing QbD include knowledge management, risk management, designing controls based on scientific understanding, and continual improvement using knowledge gained over a product's lifecycle.
1) The document presents an overview of Quality by Design (QbD) in pharmaceutical development. It defines QbD, compares the current and QbD approaches, and outlines the benefits, objectives, and elements of QbD.
2) The key elements of QbD discussed are defining objectives, determining critical quality attributes, risk assessment, experimental design, control strategy, and continuous improvement. Ishikawa and risk assessment methods are also summarized.
3) Implementing QbD provides quality medicines to patients, production improvements for manufacturers, and greater confidence for drug regulators by ensuring predefined product quality objectives.
The key elements of QbD include establishing a quality target product profile, identifying critical quality attributes, performing risk assessments, defining a design space, implementing a control strategy, and enabling continual improvement. QbD helps ensure better designed products and manufacturing processes with fewer problems, satisfying patients' needs more effectively and efficiently. It aims to eliminate waste and reduce costs. While achieving full understanding and implementation of QbD remains an ongoing challenge, its adoption is expected to realize significant benefits for both industry and regulators.
Quality by Design A Present to Future Perspectiveijtsrd
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. The Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. Mr. Rajesh Dumpala | Ms. Jaini Bhavsar | Mr. Chirag Patil "Quality by Design: A Present to Future Perspective" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd32985.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/32985/quality-by-design-a-present-to-future-perspective/mr-rajesh-dumpala
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.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
This document provides an introduction to Quality by Design (QBD) in pharmaceutical development and manufacturing. It discusses the evolution of quality approaches from chance to design. Key aspects of QBD covered include critical quality attributes (CQAs), critical material attributes (CMAs), critical process parameters (CPPs), risk assessment tools, and the role of statistics. The document presents examples of how to apply QBD concepts like quality target product profiles (QTPPs), Kano modeling, quality function deployment (QFD), and design of experiments (DoE) to identify and control elements critical to ensuring product quality.
This document summarizes a seminar presentation on Quality by Design (QbD). The presentation introduces QbD, discusses its key elements like Quality Target Product Profile, Critical Quality Attributes, risk assessment, design space, and control strategy. It provides examples of applying QbD principles to tablet manufacturing and using a QbD approach to study the downstream processing of hot-melt extrusion to tablet formation. The presentation concludes with key advantages of implementing a QbD system for pharmaceutical development and manufacturing.
Pharmaceutical QbD concepts for drug developmentGuru Balaji .S
The document discusses quality by design (QbD) in pharmaceutical development. It defines QbD as a systematic approach that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. Under QbD, the desired product performance profile, target product quality attributes, and critical material attributes are defined to identify and control sources of variability. QbD provides increased flexibility while maintaining quality standards compared to traditional quality testing approaches. Key aspects of implementing QbD include knowledge management, risk management, designing controls based on scientific understanding, and continual improvement using knowledge gained over a product's lifecycle.
1) The document presents an overview of Quality by Design (QbD) in pharmaceutical development. It defines QbD, compares the current and QbD approaches, and outlines the benefits, objectives, and elements of QbD.
2) The key elements of QbD discussed are defining objectives, determining critical quality attributes, risk assessment, experimental design, control strategy, and continuous improvement. Ishikawa and risk assessment methods are also summarized.
3) Implementing QbD provides quality medicines to patients, production improvements for manufacturers, and greater confidence for drug regulators by ensuring predefined product quality objectives.
The key elements of QbD include establishing a quality target product profile, identifying critical quality attributes, performing risk assessments, defining a design space, implementing a control strategy, and enabling continual improvement. QbD helps ensure better designed products and manufacturing processes with fewer problems, satisfying patients' needs more effectively and efficiently. It aims to eliminate waste and reduce costs. While achieving full understanding and implementation of QbD remains an ongoing challenge, its adoption is expected to realize significant benefits for both industry and regulators.
Quality by Design A Present to Future Perspectiveijtsrd
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. The Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. Mr. Rajesh Dumpala | Ms. Jaini Bhavsar | Mr. Chirag Patil "Quality by Design: A Present to Future Perspective" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd32985.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/32985/quality-by-design-a-present-to-future-perspective/mr-rajesh-dumpala
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.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
This document provides an introduction to Quality by Design (QBD) in pharmaceutical development and manufacturing. It discusses the evolution of quality approaches from chance to design. Key aspects of QBD covered include critical quality attributes (CQAs), critical material attributes (CMAs), critical process parameters (CPPs), risk assessment tools, and the role of statistics. The document presents examples of how to apply QBD concepts like quality target product profiles (QTPPs), Kano modeling, quality function deployment (QFD), and design of experiments (DoE) to identify and control elements critical to ensuring product quality.
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
1. Process analytical technology (PAT) aims to improve understanding and control of pharmaceutical manufacturing processes through measurement of critical quality parameters during processing.
2. Conventional batch processing relies on final testing of samples, which risks discarding good batches if samples fail tests. PAT allows for continuous monitoring and adjustment to ensure consistent quality throughout production.
3. Key aspects of PAT include incorporating advanced sensors and instruments for online and inline measurements of critical attributes, linking these measurements to product quality through multivariate models, and using the enhanced process understanding to design control strategies and quality into the process from the start.
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.
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls,
manufacturing failure cost, scale up issues and regulatory burden in recent past suggest otherwise. In traditional quality by testing (QbT) approach, the product quality and performance are predominantly ensured by end product testing, with limited understanding of the process and critical process parameters. Regulatory bodies are therefore focusing on implementing quality by design (QbD), a science based approach that improves
process understanding by reducing process variation and the enabling process-control strategies. In this regards, pharmaceutical industry is currently undergoing a significant transformation to streamline their R&D process, provide greater manufacturing flexibility and control, and to reduce regulatory burden. However, there is limited understanding and major concerns regarding the implementation of QbD principles in the
pharmaceutical arena. The objective of this review article is therefore to provide a comprehensive understanding on various aspects of QbD, along with addressing the concerns related to its implementation.
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.
The document discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and control based on sound science and quality risk management. It defines key QbD elements like Quality Target Product Profile, Critical Quality Attributes, Design Space, and Control Strategy. QbD aims to ensure final drug quality and has benefits like increased understanding, efficiency, and patient safety.
Quality by Design (QbD) is a systematic, holistic, and proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding through sound science and quality risk management. It involves defining a Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQAs), then linking raw material attributes and manufacturing process parameters to the CQAs. This allows designing a control strategy and establishing a design space to ensure the output meets the QTPP. QbD focuses on continuous improvement throughout the product's lifecycle.
This document discusses Quality by Design (QbD) and Design of Experiments (DoE) principles for drug product development. It aims to develop formulations that reliably deliver the desired pharmacological effects without increasing side effects or losing stability or performance over time. QbD uses a risk-based and knowledge-driven approach to understand critical quality attributes and process parameters that affect product quality. DoE is used to characterize processes and identify sources of variability to ensure consistent manufacturing. The document outlines key ICH guidelines for QbD and DoE and stresses that the goal is achieving a predictable therapeutic response through reproducible, large-scale manufacturing.
This document provides an overview of quality by design (QbD) in the pharmaceutical industry. It defines QbD as a systematic approach to development that emphasizes product and process understanding based on sound science and quality risk management. The key elements of QbD include identifying critical quality attributes and critical process parameters. QbD aims to design pharmaceutical products and processes to consistently deliver quality and has benefits like reducing batch failures and costs for industry and ensuring consistent quality for consumers.
The document discusses Process Analytical Technology (PAT), which is defined as a system for designing, analyzing, and controlling manufacturing processes through measurements of critical quality attributes during processing. PAT aims to ensure final product quality by building quality into products through enhanced process understanding and control. The key elements of a PAT framework include process understanding, principles and tools like multivariate analysis, process analyzers, process controls, continuous improvement, and risk-based approaches. PAT offers benefits like increased flexibility, reduced costs and improved yields.
The presentation discusses the current state of quality management in the pharmaceutical industry and a proposed future "desired state" based on a risk-based, science-driven approach. It highlights guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) including ICH Q6A on specifications and ICH Q8 on pharmaceutical development. The desired state focuses on process understanding, continuous monitoring and improvement rather than just documentation and testing to ensure consistent product quality.
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.
The document discusses analytical quality by design (AQbD) and its implementation. It compares traditional analytical methods to AQbD methods. AQbD uses a systematic approach including risk assessment, design of experiments, and establishing a method operable design region. A case study demonstrates developing an HPLC method for assay using an AQbD approach including target measurement, design of experiment, method validation, and establishing a method operable design region. The conclusion states AQbD requires defining the right analytical target profile and using appropriate tools to ensure the right analytics are performed at the right time.
This document discusses Quality by Design (QbD) and Process Analytical Technology (PAT). It provides background on how QbD and PAT work together to ensure consistent product quality and process efficiency. The document outlines challenges to implementing QbD and PAT, including developing an implementation strategy and integrating the systems into quality assurance. It also discusses how Wyeth is applying QbD and PAT principles across its business in a systematic manner.
This document discusses Quality by Design (QbD) in API manufacturing. It begins by quoting Joseph M. Juran that quality must be built in by design, not tested in. It then defines QbD as a systematic approach that emphasizes product and process understanding and control based on science and risk management. The document outlines some of the key aspects of QbD like design space, quality risk management, and using tools like design of experiments. It compares the traditional and QbD approaches and discusses some of the pros and cons of QbD.
Quality by design in pharmaceutical developmentManish Rajput
This document discusses the concept of Quality by Design (QbD) in pharmaceutical development. It provides background on QbD and outlines its key aspects, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life cycle management. The benefits of QbD for industry and regulators are described. Traditional and QbD approaches to pharmaceutical development are compared. Tools used in QbD such as design of experiments, risk assessment methodologies, and process analytical technology are also summarized. Finally, an example application of QbD principles to influenza vaccine development is presented.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
1. Quality by design (QbD) is a systematic approach to pharmaceutical development that begins with predefined quality objectives and emphasizes product and process understanding based on sound science.
2. Pioneer Dr. Joseph Juran first developed the concept of QbD, proposing that quality must be designed into products to avoid quality issues. The FDA further developed these ideas in a risk-based pharmaceutical quality initiative.
3. Key aspects of QbD include identifying critical quality attributes and linking them to critical material attributes and manufacturing process parameters to ensure consistent quality product delivery to patients.
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.
“Current Approach of Quality by Design” An Overviewijtsrd
In this Analysis, well look at how QbD is being practised right now. QbD represents a cutting edge methodology for enhancing the safety and efficacy of pharmaceuticals. Quality by Design QbD is a relatively new idea in the pharmaceutical industry, but it has quickly become an integral aspect of the current approach to quality. Quality by Design relies on the ICH Guidelines as its basis. Guidelines Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality Systems from the International Council for Harmonization ICH served as inspiration for this document. QbD is the most effective method now available for improving the quality of all pharmaceutical goods, but it poses a significant problem for the pharmaceutical business, whose procedures are traditionally static. Eventually, despite inevitable process and material variation, It is crucial to establish the desired product performance profile Target product Profile TPP , Target Product Quality Profile TPQP and to pinpoint the attributes of quality that are most important to the products success throughout the QbD process CQA . We may then use this information to tailor the products composition and production method to those characteristics. This results in the identification and management of sources of variability and an understanding of the effect of raw materials critical material attributes CMA and critical process parameters CPP on critical quality attributes CQAs . To which the process and technique of development must have access. Quality by Design QbD encompasses the processes of drug development and manufacturing. that guarantees the product meets the standards set out in advance. R. Kavi Bharathi | R. Sanil Kumar | Shantaram Nangude "“Current Approach of Quality by Design” An Overview" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-1 , February 2023, URL: https://www.ijtsrd.com/papers/ijtsrd53873.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/53873/“current-approach-of-quality-by-design”-an-overview/r-kavi-bharathi
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
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
1. Process analytical technology (PAT) aims to improve understanding and control of pharmaceutical manufacturing processes through measurement of critical quality parameters during processing.
2. Conventional batch processing relies on final testing of samples, which risks discarding good batches if samples fail tests. PAT allows for continuous monitoring and adjustment to ensure consistent quality throughout production.
3. Key aspects of PAT include incorporating advanced sensors and instruments for online and inline measurements of critical attributes, linking these measurements to product quality through multivariate models, and using the enhanced process understanding to design control strategies and quality into the process from the start.
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.
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls,
manufacturing failure cost, scale up issues and regulatory burden in recent past suggest otherwise. In traditional quality by testing (QbT) approach, the product quality and performance are predominantly ensured by end product testing, with limited understanding of the process and critical process parameters. Regulatory bodies are therefore focusing on implementing quality by design (QbD), a science based approach that improves
process understanding by reducing process variation and the enabling process-control strategies. In this regards, pharmaceutical industry is currently undergoing a significant transformation to streamline their R&D process, provide greater manufacturing flexibility and control, and to reduce regulatory burden. However, there is limited understanding and major concerns regarding the implementation of QbD principles in the
pharmaceutical arena. The objective of this review article is therefore to provide a comprehensive understanding on various aspects of QbD, along with addressing the concerns related to its implementation.
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.
The document discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and control based on sound science and quality risk management. It defines key QbD elements like Quality Target Product Profile, Critical Quality Attributes, Design Space, and Control Strategy. QbD aims to ensure final drug quality and has benefits like increased understanding, efficiency, and patient safety.
Quality by Design (QbD) is a systematic, holistic, and proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding through sound science and quality risk management. It involves defining a Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQAs), then linking raw material attributes and manufacturing process parameters to the CQAs. This allows designing a control strategy and establishing a design space to ensure the output meets the QTPP. QbD focuses on continuous improvement throughout the product's lifecycle.
This document discusses Quality by Design (QbD) and Design of Experiments (DoE) principles for drug product development. It aims to develop formulations that reliably deliver the desired pharmacological effects without increasing side effects or losing stability or performance over time. QbD uses a risk-based and knowledge-driven approach to understand critical quality attributes and process parameters that affect product quality. DoE is used to characterize processes and identify sources of variability to ensure consistent manufacturing. The document outlines key ICH guidelines for QbD and DoE and stresses that the goal is achieving a predictable therapeutic response through reproducible, large-scale manufacturing.
This document provides an overview of quality by design (QbD) in the pharmaceutical industry. It defines QbD as a systematic approach to development that emphasizes product and process understanding based on sound science and quality risk management. The key elements of QbD include identifying critical quality attributes and critical process parameters. QbD aims to design pharmaceutical products and processes to consistently deliver quality and has benefits like reducing batch failures and costs for industry and ensuring consistent quality for consumers.
The document discusses Process Analytical Technology (PAT), which is defined as a system for designing, analyzing, and controlling manufacturing processes through measurements of critical quality attributes during processing. PAT aims to ensure final product quality by building quality into products through enhanced process understanding and control. The key elements of a PAT framework include process understanding, principles and tools like multivariate analysis, process analyzers, process controls, continuous improvement, and risk-based approaches. PAT offers benefits like increased flexibility, reduced costs and improved yields.
The presentation discusses the current state of quality management in the pharmaceutical industry and a proposed future "desired state" based on a risk-based, science-driven approach. It highlights guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) including ICH Q6A on specifications and ICH Q8 on pharmaceutical development. The desired state focuses on process understanding, continuous monitoring and improvement rather than just documentation and testing to ensure consistent product quality.
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.
The document discusses analytical quality by design (AQbD) and its implementation. It compares traditional analytical methods to AQbD methods. AQbD uses a systematic approach including risk assessment, design of experiments, and establishing a method operable design region. A case study demonstrates developing an HPLC method for assay using an AQbD approach including target measurement, design of experiment, method validation, and establishing a method operable design region. The conclusion states AQbD requires defining the right analytical target profile and using appropriate tools to ensure the right analytics are performed at the right time.
This document discusses Quality by Design (QbD) and Process Analytical Technology (PAT). It provides background on how QbD and PAT work together to ensure consistent product quality and process efficiency. The document outlines challenges to implementing QbD and PAT, including developing an implementation strategy and integrating the systems into quality assurance. It also discusses how Wyeth is applying QbD and PAT principles across its business in a systematic manner.
This document discusses Quality by Design (QbD) in API manufacturing. It begins by quoting Joseph M. Juran that quality must be built in by design, not tested in. It then defines QbD as a systematic approach that emphasizes product and process understanding and control based on science and risk management. The document outlines some of the key aspects of QbD like design space, quality risk management, and using tools like design of experiments. It compares the traditional and QbD approaches and discusses some of the pros and cons of QbD.
Quality by design in pharmaceutical developmentManish Rajput
This document discusses the concept of Quality by Design (QbD) in pharmaceutical development. It provides background on QbD and outlines its key aspects, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life cycle management. The benefits of QbD for industry and regulators are described. Traditional and QbD approaches to pharmaceutical development are compared. Tools used in QbD such as design of experiments, risk assessment methodologies, and process analytical technology are also summarized. Finally, an example application of QbD principles to influenza vaccine development is presented.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
1. Quality by design (QbD) is a systematic approach to pharmaceutical development that begins with predefined quality objectives and emphasizes product and process understanding based on sound science.
2. Pioneer Dr. Joseph Juran first developed the concept of QbD, proposing that quality must be designed into products to avoid quality issues. The FDA further developed these ideas in a risk-based pharmaceutical quality initiative.
3. Key aspects of QbD include identifying critical quality attributes and linking them to critical material attributes and manufacturing process parameters to ensure consistent quality product delivery to patients.
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.
“Current Approach of Quality by Design” An Overviewijtsrd
In this Analysis, well look at how QbD is being practised right now. QbD represents a cutting edge methodology for enhancing the safety and efficacy of pharmaceuticals. Quality by Design QbD is a relatively new idea in the pharmaceutical industry, but it has quickly become an integral aspect of the current approach to quality. Quality by Design relies on the ICH Guidelines as its basis. Guidelines Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality Systems from the International Council for Harmonization ICH served as inspiration for this document. QbD is the most effective method now available for improving the quality of all pharmaceutical goods, but it poses a significant problem for the pharmaceutical business, whose procedures are traditionally static. Eventually, despite inevitable process and material variation, It is crucial to establish the desired product performance profile Target product Profile TPP , Target Product Quality Profile TPQP and to pinpoint the attributes of quality that are most important to the products success throughout the QbD process CQA . We may then use this information to tailor the products composition and production method to those characteristics. This results in the identification and management of sources of variability and an understanding of the effect of raw materials critical material attributes CMA and critical process parameters CPP on critical quality attributes CQAs . To which the process and technique of development must have access. Quality by Design QbD encompasses the processes of drug development and manufacturing. that guarantees the product meets the standards set out in advance. R. Kavi Bharathi | R. Sanil Kumar | Shantaram Nangude "“Current Approach of Quality by Design” An Overview" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-1 , February 2023, URL: https://www.ijtsrd.com/papers/ijtsrd53873.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/53873/“current-approach-of-quality-by-design”-an-overview/r-kavi-bharathi
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
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.
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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.
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”Rajatmishra137
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
Analytical Quality by Design Concise Review on Approach to Enhanced Analytica...ijtsrd
In the last few decades, the pharmaceutical industry has been rapidly progressing by focussing on various aspects of formulation and analytical development such as product Quality, Safety, and Efficacy. It is reflected through the increase in number of product development by the increased use of scientific tools such as QbD Quality by Design and PAT Process Analytical Technology . ICH guidelines Q8 to Q11 have specified QbD implementation in API synthetic process and also in formulation as well as analytical development. QbD has earned considerable reputation by formulation developers. It has enhanced the inculcation of scientific outlook and assessment of risks at an early stage. In this review, we have focussed on the implementation AQbD for API synthetic process and analytical methods development. AQbD key tools are identification of ATP Analytical Target Profile , CQA Critical Quality Attributes with risk assessment, and, MODR method operable design region . AQbD intends to provide product with highest quality through the minimisation of risks and also by providing good input for PAT approach. Thus, AQbD can act as an effective method towards innovative approach of Analytical Method Development along with meeting the necessary desired specifications. Bhosale Abhilash | Darekar Shubhangi | Dr. V. U Barge | Dr. Ashok Bhosale "Analytical Quality by Design: Concise Review on Approach to Enhanced Analytical Method Development" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-3 , April 2020, URL: https://www.ijtsrd.com/papers/ijtsrd30574.pdf Paper Url :https://www.ijtsrd.com/pharmacy/other/30574/analytical-quality-by-design-concise-review-on-approach-to-enhanced-analytical-method-development/bhosale-abhilash
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.
quality by design in pharmaceutical development ICH Q8 guidelinessSUJITHA MARY
The document provides an overview of ICH Q8 guidelines for quality by design (QbD) in pharmaceutical development. It discusses key aspects of the QbD framework including defining critical quality attributes and critical process parameters. The guidelines aim to enhance product and process understanding using a science- and risk-based approach. This allows for greater control and consistency in manufacturing. The document also outlines regulatory and industry perspectives, as well as examples of applying QbD and modeling techniques scientifically.
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 is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
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.
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.
This document discusses Quality by Design (QbD), which is a strategic process for drug development and manufacturing to ensure intended performance in terms of purity and efficacy. QbD has four key components: defining product design goals, discovering the process design, understanding the control space, and targeting the operating space. It is a tool for efficient drug development that relies on building quality in from the beginning. Benefits include eliminating failures, reducing costs, and ensuring consistent quality. Key elements include defining quality targets, identifying attributes, performing risk analysis, determining critical aspects, and establishing a control strategy.
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
The document discusses the concept of Pharmaceutical Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. QbD aims to design quality products and manufacturing processes that consistently deliver intended performance, following ICH guidelines Q8 on pharmaceutical development, Q9 on quality risk management, and Q10 on pharmaceutical quality systems. Implementing QbD provides benefits like eliminating batch failures, minimizing deviations, and ensuring consistent product quality.
The document discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. QbD has been adopted by the FDA and aims to design quality into products and manufacturing processes from the beginning. It provides benefits like reduced batch failures, cost savings, and more efficient regulatory oversight. The key aspects of QbD include defining target quality attributes, identifying critical process parameters, establishing a design space, and implementing a risk-based control strategy.
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This paper aims to outline the executive regulations, survey standards, and specifications required for the implementation of the Sudan Survey Act, and for regulating and organizing all surveying work activities in Sudan. The act has been discussed for more than 5 years. The Land Survey Act was initiated by the Sudan Survey Authority and all official legislations were headed by the Sudan Ministry of Justice till it was issued in 2022. The paper presents conceptual guidelines to be used for the Survey Act implementation and to regulate the survey work practice, standardizing the field surveys, processing, quality control, procedures, and the processes related to survey work carried out by the stakeholders and relevant authorities in Sudan. The conceptual guidelines are meant to improve the quality and harmonization of geospatial data and to aid decision making processes as well as geospatial information systems. The established comprehensive executive regulations will govern and regulate the implementation of the Sudan Survey Geomatics Act in all surveying and mapping practices undertaken by the Sudan Survey Authority SSA and state local survey departments for public or private sector organizations. The targeted standards and specifications include the reference frame, projection, coordinate systems, and the guidelines and specifications that must be followed in the field of survey work, processes, and mapping products. In the last few decades, there has been a growing awareness of the importance of geomatics activities and measurements on the Earths surface in space and time, together with observing and mapping the changes. In such cases, data must be captured promptly, standardized, and obtained with more accuracy and specified in much detail. The paper will also highlight the current situation in Sudan, the degree to which survey standards are used, the problems encountered, and the errors that arise from not using the standards and survey specifications. Kamal A. A. Sami "Concepts for Sudan Survey Act Implementations - Executive Regulations and Standards" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63484.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63484/concepts-for-sudan-survey-act-implementations--executive-regulations-and-standards/kamal-a-a-sami
Towards the Implementation of the Sudan Interpolated Geoid Model Khartoum Sta...ijtsrd
The discussions between ellipsoid and geoid have invoked many researchers during the recent decades, especially during the GNSS technology era, which had witnessed a great deal of development but still geoid undulation requires more investigations. To figure out a solution for Sudans local geoid, this research has tried to intake the possibility of determining the geoid model by following two approaches, gravimetric and geometrical geoid model determination, by making use of GNSS leveling benchmarks at Khartoum state. The Benchmarks are well distributed in the study area, in which, the horizontal coordinates and the height above the ellipsoid have been observed by GNSS while orthometric heights were carried out using precise leveling. The Global Geopotential Model GGM represented in EGM2008 has been exploited to figure out the geoid undulation at the benchmarks in the study area. This is followed by a fitting process, that has been done to suit the geoid undulation data which has been computed using GNSS leveling data and geoid undulation inspired by the EGM2008. Two geoid surfaces were created after the fitting process to ensure that they are identical and both of them could be counted for getting the same geoid undulation with an acceptable accuracy. In this respect, statistical operation played an important role in ensuring the consistency and integrity of the model by applying cross validation techniques splitting the data into training and testing datasets for building the geoid model and testing its eligibility. The geometrical solution for geoid undulation computation has been utilized by applying straightforward equations that facilitate the calculation of the geoid undulation directly through applying statistical techniques for the GNSS leveling data of the study area to get the common equation parameters values that could be utilized to calculate geoid undulation of any position in the study area within the claimed accuracy. Both systems were checked and proved eligible to be used within the study area with acceptable accuracy which may contribute to solving the geoid undulation problem in the Khartoum area, and be further generalized to determine the geoid model over the entire country, and this could be considered in the future, for regional and continental geoid model. Ahmed M. A. Mohammed. | Kamal A. A. Sami "Towards the Implementation of the Sudan Interpolated Geoid Model (Khartoum State Case Study)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63483.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63483/towards-the-implementation-of-the-sudan-interpolated-geoid-model-khartoum-state-case-study/ahmed-m-a-mohammed
Activating Geospatial Information for Sudans Sustainable Investment Mapijtsrd
Sudan is witnessing an acceleration in the processes of development and transformation in the performance of government institutions to raise the productivity and investment efficiency of the government sector. The development plans and investment opportunities have focused on achieving national goals in various sectors. This paper aims to illuminate the path to the future and provide geospatial data and information to develop the investment climate and environment for all sized businesses, and to bridge the development gap between the Sudan states. The Sudan Survey Authority SSA is the main advisor to the Sudan Government in conducting surveying, mappings, designing, and developing systems related to geospatial data and information. In recent years, SSA made a strategic partnership with the Ministry of Investment to activate Geospatial Information for Sudans Sustainable Investment and in particular, for the preparation and implementation of the Sudan investment map, based on the directives and objectives of the Ministry of Investment MI in Sudan. This paper comes within the framework of activating the efforts of the Ministry of Investment to develop technical investment services by applying techniques adopted by the Ministry and its strategic partners for advancing investment processes in the country. Kamal A. A. Sami "Activating Geospatial Information for Sudan's Sustainable Investment Map" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63482.pdf Paper Url: https://www.ijtsrd.com/engineering/information-technology/63482/activating-geospatial-information-for-sudans-sustainable-investment-map/kamal-a-a-sami
Educational Unity Embracing Diversity for a Stronger Societyijtsrd
In a rapidly changing global landscape, the importance of education as a unifying force cannot be overstated. This paper explores the crucial role of educational unity in fostering a stronger and more inclusive society through the embrace of diversity. By examining the benefits of diverse learning environments, the paper aims to highlight the positive impact on societal strength. The discussion encompasses various dimensions, from curriculum design to classroom dynamics, and emphasizes the need for educational institutions to become catalysts for unity in diversity. It highlights the need for a paradigm shift in educational policies, curricula, and pedagogical approaches to ensure that they are reflective of the diverse fabric of society. This paper also addresses the challenges associated with implementing inclusive educational practices and offers practical strategies for overcoming barriers. It advocates for collaborative efforts between educational institutions, policymakers, and communities to create a supportive ecosystem that promotes diversity and unity. Mr. Amit Adhikari | Madhumita Teli | Gopal Adhikari "Educational Unity: Embracing Diversity for a Stronger Society" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64525.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64525/educational-unity-embracing-diversity-for-a-stronger-society/mr-amit-adhikari
Integration of Indian Indigenous Knowledge System in Management Prospects and...ijtsrd
The diversity of indigenous knowledge systems in India is vast and can vary significantly between different communities and regions. Preserving and respecting these knowledge systems is crucial for maintaining cultural heritage, promoting sustainable practices, and fostering cross cultural understanding. In this paper, an overview of the prospects and challenges associated with incorporating Indian indigenous knowledge into management is explored. It is found that IIKS helps in management in many areas like sustainable development, tourism, food security, natural resource management, cultural preservation and innovation, etc. However, IIKS integration with management faces some challenges in the form of a lack of documentation, cultural sensitivity, language barriers legal framework, etc. Savita Lathwal "Integration of Indian Indigenous Knowledge System in Management: Prospects and Challenges" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63500.pdf Paper Url: https://www.ijtsrd.com/management/accounting-and-finance/63500/integration-of-indian-indigenous-knowledge-system-in-management-prospects-and-challenges/savita-lathwal
DeepMask Transforming Face Mask Identification for Better Pandemic Control in...ijtsrd
The COVID 19 pandemic has highlighted the crucial need of preventive measures, with widespread use of face masks being a key method for slowing the viruss spread. This research investigates face mask identification using deep learning as a technological solution to be reducing the risk of coronavirus transmission. The proposed method uses state of the art convolutional neural networks CNNs and transfer learning to automatically recognize persons who are not wearing masks in a variety of circumstances. We discuss how this strategy improves public health and safety by providing an efficient manner of enforcing mask wearing standards. The report also discusses the obstacles, ethical concerns, and prospective applications of face mask detection systems in the ongoing fight against the pandemic. Dilip Kumar Sharma | Aaditya Yadav "DeepMask: Transforming Face Mask Identification for Better Pandemic Control in the COVID-19 Era" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64522.pdf Paper Url: https://www.ijtsrd.com/engineering/electronics-and-communication-engineering/64522/deepmask-transforming-face-mask-identification-for-better-pandemic-control-in-the-covid19-era/dilip-kumar-sharma
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
Reimagining Your Library Space: How to Increase the Vibes in Your Library No ...Diana Rendina
Librarians are leading the way in creating future-ready citizens – now we need to update our spaces to match. In this session, attendees will get inspiration for transforming their library spaces. You’ll learn how to survey students and patrons, create a focus group, and use design thinking to brainstorm ideas for your space. We’ll discuss budget friendly ways to change your space as well as how to find funding. No matter where you’re at, you’ll find ideas for reimagining your space in this session.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
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knowledge on this subject in an independent and integrated
manner.3,4 To launch a successful QbDprogram,thefirststep
is to identify the process components required for
production quality and to develop good authenticated
analytical methods to test those parameters. The purpose of
this review article is to provide a comprehensive
understanding of the various aspects of QBD, with related
problems regarding its implementation.4
Benefits of QbD
Eliminate batch failures
Minimize deviations and costly investigations
Avoid regulatory compliance problems
Empowerment of technical staff
Efficient, agile, flexible system
Increase manufacturing efficiency, reduce costs and
project rejections and waste
Build scientific knowledge base for all products
Better interact with industry on science issues
Ensure consistent information
Incorporate risk management
Reduce end-product testing
Speed-up release decision
QbD development process include:
Get started with a target product profile that describes
the product's usage, security and effectiveness
Define the target product quality profile which will be
used by formulators and process engineers as a
quantitative surrogate for clinical safety and efficiency
aspects during productive development.
Collect knowledge of known knowledge about drug
substances, potential emittersandprocessmechanisms.
Use the Risk Assessment to give priority to the
knowledge gap for further inspections
Design a formulation and identify the final product's
important material (quality) in which target product
quality should be controlled to meet the quality profile.
Create a production process for the final product with
this important material properties.
It is necessary to identify important processparameters
and input (raw) content attributes in order to achieve
these important material properties of end products.
Use the Risk Assessment to give priority to the process
parameters and content properties for experimental
verification. Combine pre-learning with the use of
design spaces or other presentation understanding
processes.
Install a control policy for the entire process, which may
include input content controls, process controls and
monitors, individual space or / or end product tests for
multiple unit operations. The expected change inthecontrol
policy scale is necessary and guidance can be done through
risk appraisal. Continuously process and update to ensure
consistent quality.5
Objectives of QBD
Pharmaceutical QBD is a systematic approach to
development whichstartswiththepredeterminedobjectives
and emphasizes on understanding and controlling
production and processing based on sound science and
quality risk management. The objectives of pharmaceutical
QBD may include:
1. To get meaningful product quality specifications based
on medical efficiency
2. To increasing processing capacity and reducingproduct
changes and defects by increasing production capacity
and process structure, understanding and control
3. To increase product development and production
efficiency
4. To post management of original cause analysis and
approval changes
Under the QBD, these targets can often be achieved by
continuously producing a strong formulation and
manufacturing process to deliver the desired clinical
performance of the quality of the product and then
continuously deliver the desired product quality. Since the
introduction of Pharmaceutical QBD, the FDA has made
significant progress in achieving its first objective:
performance-based quality specifications.Someexamplesof
FDA policies include labeled capsules labeled for tablet
scoring and mimicry. Comparative treatment indicators on
recent FDA discussions show that this limit is the limit on
medicines and the actual attributes of general medicinal
products.5,6
Nevertheless, it should be recognized that the ICH
documents did not explicitly recognizeclinical performance-
based features as a QBD target, even though this recent
scientific paper had been identified.
The second objective of Pharmaceutical QBD is to increase
processing capacity and reduce the difference in product
which often leads to product defects, precipitation and
memory. This product requires a successful product and
process. In addition, understanding improved production
and processes facilitates the identification and control ofthe
components affecting the quality of the drug product.After
regulatory approval, it isnecessarytoimprovetheprocessof
attempt to reduce the product's differences, defects,
precipitation and reminder.6,7,8
QBD uses systematic approach to product design and
development. As such, itincreasesthedevelopmentcapacity,
speed and formulation design. In addition, they transferring
resources from downstream modificationmodetoupstream
proactive mode.6 This product increases the capacity of the
manufacturer to identify the root causes of failure.
Therefore, increasing productivity and productivity
efficiency is the third objective of QbD of pharmaceuticals.7
The final purpose of QBD is to post management of the root
cause analysisandapproval changes.Withoutunderstanding
better production and processing, the ability to effectively
scale-up and analyze the original reason analysis is limited,
and the proposed large amount of additional data set is
required to be produced.8 Changes to FDA Provides a
Framework for Guidance Post Approval Changes. Recently,
the FDA has issued guidance for the purpose of reducing
regulatory filing requirements for approved low-risk
chemistry, production and control(CMC) changes in
approved product approvals.8,9
Elements of QbD:
From an QbD perspective to product development, an
applicant recognizes the qualities that are important to the
patient's perspective, converts it into important quality
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properties (CQA) in the drug product and establishes
relationships between Formulation / Manufacturing
Variables and CQA to deliver continuously. Patientsproduce
such CQS drug.10 QbD has the following components: A
quality target product profile (QTPP) that identifies the
critical quality attributes (CQAs) of the drug product
1. Product Design and Understanding with Identifying
Critical Content Properties (CMA)
2. Identifying Critical Process Parameters (CPP) and
designing and understanding process, including
complete information on scale-up systems, connecting
CMA and CPA to CQA
3. Controlling process, which includes medicinal
properties, emergence, and medicinal production and
control details for each stage of the production process.
Process capability and continual improvement
Quality Target Product ProfilethatIdentifiestheCritical
Quality Attributes of the Drug Product
The QTPP is a potential summary of the quality features
of a drug product, which will ideally be achieved to
ensure the ideal quality, to ensure the safety and
effectiveness of the drug product's account. KTPP
prepares design support for product development.
Considering to include in the QtPP can include:
Use for diagnostic setting, administrative route, dosage
form and delivery system.
Dosage strength
Container closure system
To release or dispersant drug dispensatory medicines
and develop properties (eg disruptionandaerodynamic
efficiency) affecting pharmacokinic features
Medicinal production quality criteria (e.g., sterile
refinement, purity, stability and freeing ofdrugs)forthe
desired product
The introduction of drug product CQA is the next step in the
development of drug products. CQQ is a physical, chemical,
biological, or microbiological feature, which includes the
expiry of output material, which must be in the appropriate
range, range, or distribution to ensure proper product
quality.10,11
Quality of the drug product may include identification,
testing, material consistency, decreasing products, residual
supplements, drug discharge or dissolution, moisture
content, micro-organisms limitations and color, size, size,
odor, score configuration and physical properties.
Generosity This feature can be serious or important.12 The
severity of properties is primarily based on the intensity of
the loss of the patient, which is necessary for the product to
fall outside the acceptable range. The likelihood of event,
findability or control does not affect the severity of the
attribute.12 It seems that the new product should be fixed
enough before starting anydevelopment work.However,the
value of predicting the target characteristics of a drug
product has been reduced significantly for a number of
years. As a result, a hypothetical defined Qtpp deficiencyhas
caused a lot of time or valuable resources. Recent papers by
RAW et al. Explains the importance of defining the correct
QTPP before running any development. Also, QBD examples
illustrate the use and usage of QTPP.13
Product Design and Understanding
As discussed in the ICHQ8 (R2) guidance, in the past few
years, the QBD focus is on the process structure,
understanding and control. It should be emphasized that
product design, understanding and control are equally
important.13
The product design determines whether the patient is able
to meet the needs of the patients, which are confirmed by
clinical studies. Determines whether the product design is
able to maintain its performance throughitsshelflife, whose
stability is confirmed by the study. Understanding this kind
of product can preventsomehistoricstabilityfromfailures.13
The main goal of product design and understanding is to
develop a strong product that can deliver the desired QTPP
on product shelf life. The product design is open-ended and
can allow for many design routes. The main components of
product design and understanding include:
Physical, chemical andbiological propertiesofmedicinal
properties.
Identity and selection of external types and grades, and
internal stimulus variation knowledge
Interactions of drug and excipients
Optimization of formulation and identification of CMAs
of both excipients and drug substance
To design and develop a robust drug product that has the
intended CQAs, a product development scientist must give
serious consideration to the physical, chemical, and
biological properties of the drug substance. Physical
properties include physical description (particle size
distribution and particle morphology), polymorphism and
form transformation, aqueous solubility as a function of pH,
intrinsic dissolution rate, hygroscopicity, and melting point.
Pharmaceutical solid polymorphism, for example, has
received much attention recently since it can impact
solubility, dissolution, stability, and manufacturability.
Chemical properties include pKa, chemical stability in solid
state and in solution, as well as photolytic and oxidative
stability. Biological properties include partition coefficient,
membrane permeability, and bioavailability.14
Pharmaceutical excipientsarecomponentsofa drugproduct
other than the active pharmaceutical ingredient. Excipients
can aid in the processing of the dosage form during its
manufacture; protect, support, or enhance stability,
bioavailability, or patient acceptability; assist in product
identification; or enhance any other attribute of the overall
safety, effectiveness, or delivery of the drug during storage
or use. They are classified by the functions they perform in a
pharmaceutical dosage form. Among 42 functional excipient
categories listed in USP/NF, commonly used excipients
include binders, disintegrates, fillers (diluents), lubricants,
glidants (flow enhancers), compression aids, colors,
sweeteners, preservatives, suspending/dispersing agents,
pH modifiers/buffers, tonicityagents,filmformers/coatings,
flavors, and printing inks. The FDA’s inactive ingredients
database lists the safety limits of excipients based on prior
use in FDA-approved drug products.11-14
It is well recognized that excipients can be a major source of
variability. Despite the fact that excipients can alter the
stability, manufacturability, and bioavailability of drug
products, the general principlesofexcipientselectionarenot
well-defined, and excipients are often selected ad
hoc without systematic drug-excipient compatibilitytesting.
To avoid costly material wastage and time delays, ICH Q8
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(R2) recommends drug-excipient compatibility studies to
facilitate the early prediction of compatibility. Systematic
drug-excipientcompatibilitystudiesofferseveraladvantages
as follows: minimizing unexpected stability failures which
usually lead to increased development time and cost,
maximizing the stability of a formulation and hencetheshelf
life of the drug product, and enhancing the understanding of
drug-excipient interactions that can help with root cause
analysis should stability problems occur.10-16
Formulation optimizationstudiesare essential indeveloping
a robust formulation that is not on the edge of failure.
Without optimization studies, a formulationismorelikelyto
be high risk because it is unknown whether any changes in
the formulation itself or in the raw material properties
would significantly impact the quality and performance of
the drug product, as shown in recent examples.15
Formulation optimization studies provide important
information on the following:
Robustness of the formulation including establishing
functional relationships between CQAs and CMAs
Identification of CMAs of drugsubstance, excipients,and
in-process materials
Development of control strategies for drug substance
and excipients
In a QbD approach, it is not the number of optimization
studies conducted but rather the relevance of the
studies and the utility of the knowledge gained for
designing a quality drug product that is paramount. As
such, the QbD does not equal design of experiments
(DoE), but the latter could be an important component
of QbD.
Drug substance, excipients, and in-process materials may
have many CMAs. A CMA is a physical, chemical, biological,
or microbiological property or characteristic of an input
material that should be within anappropriatelimit,range, or
distribution to ensure the desired quality of that drug
substance, excipient, or in-process material.Forthepurpose
of this paper, CMAs are considered different from CQAs in
that CQAs are for output materials including product
intermediates and finished drug product while CMAs arefor
input materials including drugsubstanceand excipients.The
CQA of an intermediate may become a CMA of that same
intermediate for a downstream manufacturing step.16
Since there are many attributes of the drug substance and
excipients that could potentially impact the CQAs of the
intermediates and finished drugproduct,itisunrealisticthat
a formulation scientist investigate all the identified material
attributes during the formulation optimization studies.
Therefore, a risk assessment would be valuable in
prioritizing which material attributeswarrantfurtherstudy.
The assessment should leverage common scientific
knowledge and the formulator’s expertise. A material
attribute is critical when a realistic change in that material
attribute can have a significant impact on the quality of the
output material. Product understanding includes the ability
to link input CMAs to output CQAs.11-15 The steps taken to
gain product understanding may include the following:
1. Identify all possible known input material attributes
that could impact the performance of the product
2. Use risk assessment and scientificknowledgetoidentify
potentially high risk attributes
3. Establish levels or ranges of these potentially high-risk
material attributes
4. Design and conduct experiments, using DoE when
appropriate
5. Analyze the experimental data and,whenpossible,apply
first principle models to determine if an attribute is
critical
6. Develop a control strategy. For critical material
attributes, define acceptable ranges. For noncritical
material attributes, the acceptable range is the range
investigated. When more than one excipient is involved,
these defined acceptable ranges may be termed
formulation design space
Steps for QBD
Can drugs be produced by QBD processing? The answer is
yes. The following must be included in the development
process. Changes to the steps may be needed to meet the
individual needs of the company. The following may seem
daunting at first, but once they are practiced, they will come
in handy.QBD must be a daily mantra, and I have lived
through such experiences. Long-term benefits are the best
and most effective business processes. It can also reduce
regulatory complexity. .
Understand and think that all "drug molecules aregoing
to be commercialized.
Explain the chemistry and kinetics of the product.
Understand the physics and chemistry of the processes
involved, including them and translating them into
financial business processes.
Understand how to deal in chemistry and kinetics so
that the business process is producing the least cost but
does not require the repetitionofa highquality"quality"
product.
Understand and familiarizeyourselfwiththe equipment
and technologies available and use "Cross-Fruitize" not
only in the pharmaceutical industry but also in other
industries. This is important, because often powerful
drugs do not require a large batch.
Make sure your company has the "right" caliber
expertise to develop and implement the above
improvements.
Because the above-mentioned community benefits are not
fully understood, the batch process is often an exact replica
of the laboratory process. Lack of understanding of the
above factors also results in investments that are more than
necessary. For this reason, continuous processes for the
manufacture of pharmaceuticals are not considered.11
Pharmaceutical Tools
Although not officially defined, the term "prior knowledge"
has been widely used in workshops, seminars and
presentations. In regulatory submissions, applicants sought
to use prior knowledge as a "valid"reasonfortherestoration
of prior scientific use or to conduct necessary scientific
studies.13
Knowledge can be defined as familiarity with someone or
something, which can include information, facts,
descriptions and / or skills through experience or
education.The word "before" in the word "prior knowledge"
not only means "before", but is also associated with
ownership and privacy for public ownership. Thus, for the
purposes of this paper, prior knowledge can only be gained
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through experience, not education. Public knowledgecan be
knowledge acquired through education or public literature.
Prior knowledge in the QBD framework usually refers to
knowledge that results from previous experience not
available in the previous literature. Prior studies may
already have the proprietary information,understanding, or
expertise that applicants receive.14
Risk Assessment
ICH Q9 Quality Risk Management indicates that "the
production and use of a drug product, along with its
constituents, necessarily takes some degree of risk.9 Quality
risk assessment should bebasedonscientificknowledgeand
should ultimately be linked to patient safety, and
documentation of effort, formality and quality risk
management processesshouldbeconsistent withthelevel of
risk "ICH Q9 provides a systematic approach to quality risk
management and does not address risk assessment,
especially in product development. However, the risk
assessment tools identified in ICH Q9 also apply to risk
assessment in product development.10
The purpose of risk assessmentpriortodevelopmentstudies
is to identify potential high risk and identify process
variables that may affect the qualityofthedrugproduct.This
helps prioritize which studies need to be conducted and is
often driven by knowledge gaps or uncertainties.Theresults
of the study determine which variables are important and
which are not, which facilitates the establishment of a
control strategy.11 The result of a risk assessment is to
identify variables to experiment with. ICH Q9 does not
provide a comprehensive list of common risk assessment
tools as follows:
Basic risk managementfacilitationmethods(flowcharts,
check sheets, etc.)
Fault tree analysis
Risk ranking and filtering
Preliminary hazard analysis
Hazard analysis and critical control points
Failure mode effects analysis
Failure mode, effects, and criticality analysis
Hazard operability analysis
Supporting statistical tools
It may be appropriate to adapt these tools to use in specific
areas related to the quality of the drug and the quality of the
product.
Mechanistic Model, Design of Experiments, and Data
Analysis
Understanding the product and process is a key component
of QBD. To best serve these purposes, in addition to the
mechanical model, the DoE is an excellent tool that allows
pharmacologists to deal with factors according to a
predetermined design. TheDOEalsorevealstherelationship
between the input component and the output response. A
series of structured tests is designed in which planned
changes are made to the process or input variables of the
system. The impact of these changes on predefinedoutput is
then evaluated. From the traditional integral pointofviewof
development studies, the strength of the DOE istheabilityto
properly uncover how factors together affect the output
response.7
The DOE allows you to quantify the interaction terms of the
variables. Doi is important as a formal way of increasing the
informationgainedwhileminimizingthe resourcesrequired.
DOE studies canbecombinedwithmechanism-basedstudies
to maximize product and process understanding.9 When
applied to the DOE formulation or development process,the
input variables include the raw material or excipients and
the physical attributes of the process parameters (e.g.,
particle size or spray rate) (e.g. particle size), while the
output has important quality characteristics - process
material or final. Pharmaceutical products(eghomogeneous
mixtures, particle sizes or granules, tablets Assay, material
uniformity or particle size distribution of drug release).
DOE can help identify optimal conditions, CMAs, CPPs and
finally design space. Recent publications by FDA scientists
have shown the use of DOEs in productandprocessdesign.11
Process Analytical Technology
The use of PAT can be part of the control strategy. The ICH
Q8 (R2) process identifies PAT usage to ensure that the
installed space remains in place. PAT can show go / no
decisions for continuous monitoringofCPP,CMAorCQA and
to maintain the process in the design space. In-processing
testing, CMA or CQAA can also be calculatedonlineorsimilar
to PAT.12-15
Both of these applications of PAT were more effective in
detecting failure than just end-product testing. In a more
robust process, PAT can enabletheactivecontrol ofCMAand
/ or CPP and the timely adjustment of input material that
changes the environmental parameters or adversely affects
the quality of the drug product.15
Application of PAT involves four key componentsasfollows:
Multivariate data acquisition and analysis
Process analytical chemistry tools
Process monitoring and control
Continuous process optimization and knowledge
management
Multivariate data acquisition and analysis requires a
scientific understanding of the process and identifying
important material attributes and process parameters that
influence product quality and integratesthisknowledgeinto
process controls, which is essential to understanding the
process in the QBD context. Process analytical chemistry
tools provide in-situ data about real-time and process
conditions.17
Multivariate data analysis captures raw data from PAT tools
and combines it with CQAS. Based on the results of the data
analysis, process controls adjust important variables to
assure CCAA completion. The information gathered about
the process provides the basis for further process
optimization. FDA laboratory studies promise several PAT
tools and chemo metric approaches.17
CONCLUSION
The purpose of pharmaceutical QBD implementation is to
increase product development and production capacity and
enhance post approval change management, thereby
reducing product changes and defects. This is achieved by
designing a robust formulation and production process and
producing clinically relevant specifications.Keycomponents
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of pharmaceutical QBD can include QTPP, product design
and understanding, process design and understanding and
scale up, control strategy and continuous improvement.
Prior knowledge, risk assessment, DOE and PAT are tools to
facilitate QBD implementation. Finally, production and
processing capacity is evaluated and post approval is
continually improved during product lifecyclemanagement.
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