QbD within the regulatory framework: Current and Future Perspectives provides an overview of Quality by Design (QbD), its regulatory framework, and perspectives on its current and future implementation. QbD is a science-based, risk-based, and proactive approach to pharmaceutical development and manufacturing. Key updates include the finalization of ICH Q8 Annex and ongoing QbD submission pilots. Critical steps for implementation involve defining target product profiles, critical quality attributes, and design spaces. Future perspectives include holistic versus unit operation approaches and integrating development and manufacturing teams. Business considerations center around benefits, requirements, costs, and flexibility within the evolving regulatory landscape.
This document summarizes a presentation on qualifying critical utilities like HVAC and water systems. It discusses the three stages of process validation according to FDA guidance: process design, process qualification, and continued process verification. It emphasizes building quality into the process from the beginning through understanding risk and science. Utilities and equipment must be qualified before process validation. Monitoring ensures the process remains in control.
This document discusses quality by design (QbD) and its implementation in the biopharmaceutical industry. It makes the following key points:
1) QbD aims to increase process knowledge through systematically understanding how manufacturing processes impact product quality.
2) QbD has been implemented through upfront experimentation in process development and increased data collection and analysis during manufacturing.
3) Better data collection, analysis, and control are needed to fully realize the benefits of QbD such as lower costs and improved quality and productivity.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
Generic product development with QbD pathwayGuru Balaji .S
This document outlines the key steps for generic drug product development using a Quality by Design (QbD) pathway, including supplier selection, API and excipient compatibility studies, process development from lab to pilot to pivotal scale, formula optimization at each stage, manufacturing demonstration batches, biostudies, stability testing, and e-CTD regulatory submission with defined quality target product profile, critical quality attributes, critical material attributes, and control strategy.
Quality by Design (Qbd) in Product Life Cycle Management (PLCM)Dr. Girish S Sonar
This presentation will cover introduction of QbD, benefits & misconception about QbD. Nowadays, the application of QbD in the PLCM is a widely used in the pharma industry to understand product thoroughly, reduce development and post approval cost and reduce failures. The topic is emphasis on QbD element, QbD stages, Optimization studies, Quality risk management, Risk management tools, Post submission phase and their relation.
This document outlines the key stages and decision points in developing a drug product from early research through commercialization. It discusses the critical drug product development deliverables, including clinical trial materials, regulatory documentation, and robust manufacturing technology. Several decision criteria are presented at key stages to evaluate progressing a product from discovery to clinical trials to registration and market launch. Finally, it stresses the importance of selecting a development partner with the appropriate technical capabilities and quality systems to help efficiently deliver a registered product.
The document provides background information on two speakers, Christophe Debou and Tomasz de Jastrzebiec Wykowski, who will be presenting at the Agile Eastern Europe Conference on killing the myths about Agile and CMMI. The speakers' backgrounds demonstrate experience with both traditional approaches like CMMI and adaptive approaches like Scrum and Kanban. The presentation will discuss what Agile and CMMI are, compare their structures and contents, and address common problems and misconceptions when combining the two frameworks.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
This document summarizes a presentation on qualifying critical utilities like HVAC and water systems. It discusses the three stages of process validation according to FDA guidance: process design, process qualification, and continued process verification. It emphasizes building quality into the process from the beginning through understanding risk and science. Utilities and equipment must be qualified before process validation. Monitoring ensures the process remains in control.
This document discusses quality by design (QbD) and its implementation in the biopharmaceutical industry. It makes the following key points:
1) QbD aims to increase process knowledge through systematically understanding how manufacturing processes impact product quality.
2) QbD has been implemented through upfront experimentation in process development and increased data collection and analysis during manufacturing.
3) Better data collection, analysis, and control are needed to fully realize the benefits of QbD such as lower costs and improved quality and productivity.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
Generic product development with QbD pathwayGuru Balaji .S
This document outlines the key steps for generic drug product development using a Quality by Design (QbD) pathway, including supplier selection, API and excipient compatibility studies, process development from lab to pilot to pivotal scale, formula optimization at each stage, manufacturing demonstration batches, biostudies, stability testing, and e-CTD regulatory submission with defined quality target product profile, critical quality attributes, critical material attributes, and control strategy.
Quality by Design (Qbd) in Product Life Cycle Management (PLCM)Dr. Girish S Sonar
This presentation will cover introduction of QbD, benefits & misconception about QbD. Nowadays, the application of QbD in the PLCM is a widely used in the pharma industry to understand product thoroughly, reduce development and post approval cost and reduce failures. The topic is emphasis on QbD element, QbD stages, Optimization studies, Quality risk management, Risk management tools, Post submission phase and their relation.
This document outlines the key stages and decision points in developing a drug product from early research through commercialization. It discusses the critical drug product development deliverables, including clinical trial materials, regulatory documentation, and robust manufacturing technology. Several decision criteria are presented at key stages to evaluate progressing a product from discovery to clinical trials to registration and market launch. Finally, it stresses the importance of selecting a development partner with the appropriate technical capabilities and quality systems to help efficiently deliver a registered product.
The document provides background information on two speakers, Christophe Debou and Tomasz de Jastrzebiec Wykowski, who will be presenting at the Agile Eastern Europe Conference on killing the myths about Agile and CMMI. The speakers' backgrounds demonstrate experience with both traditional approaches like CMMI and adaptive approaches like Scrum and Kanban. The presentation will discuss what Agile and CMMI are, compare their structures and contents, and address common problems and misconceptions when combining the two frameworks.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
The document discusses approaches for reengineering laboratory processes to accelerate business output. It provides an overview of a mini workshop focusing on scheduling in the laboratory and process mapping, particularly value stream mapping. The workshop aims to review efficiency improvement approaches, apply tools like scheduling and process mapping to a case study, and review lessons learned.
FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.
Zhejiang Qiming Biotech Co., Ltd. is a generic API manufacturer and contract development and manufacturing organization formed in 2010 through the merger of Eastbound Synopharma and the API division of Qiming Pharma. Qiming Biotech has over 17 years of experience in API and intermediate manufacturing for the pharmaceutical industry. The company utilizes a cGMP facility and experienced staff to provide custom process development and manufacturing solutions. Qiming Biotech focuses on cGMP and non-cGMP production of APIs and intermediates for pharmaceutical and veterinary clients.
The document discusses documentation requirements for ISO 9001 certification. It notes that some organizations see ISO certification as simply a way to get a certificate, but that the true value comes from implementing an effective quality management system. It emphasizes that top management must plan and implement the QMS. The document also discusses reducing documentation requirements in the revised ISO 9001 standard and taking a lean approach to documentation to avoid creating an unnecessary paperwork burden. It proposes a tiered documentation structure with a high-level quality manual at the top level and more detailed procedures, instructions, and records at lower levels.
This document discusses Just-in-Time (JIT) production systems. JIT aims to receive supplies and manufacture components just in time for the next operation, reducing inventory levels. Key aspects of JIT include selling products before manufacturing them based on customer orders, and planning production starting from the final operation backwards. The document also discusses implementing JIT through a sequence of projects to improve cost, quality, delivery time, flexibility and innovation.
This PhD dissertation examines how companies can optimize their product change process under simultaneous pressures to be lean, agile, and innovative. The research was conducted over three action research cycles with a large telecommunications supplier. Each cycle focused on minimizing one factor: costs in Cycle 1, order delivery time in Cycle 2, and product change time in Cycle 3. The results of each cycle provided insights into how optimizing for one factor impacted the product change process and identified positive and negative effects. Overall, the research aimed to develop a balanced optimization approach across multiple strategies rather than focusing on extremes of any single strategy.
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
Presented by Guillaume Plane on September 22, 2016
The document discusses strategies for achieving manufacturing excellence, including adopting a lean approach, strengthening manufacturing capabilities, and establishing world-class manufacturing processes. It emphasizes continuous improvement, quality focus, flexibility, and customer orientation. Specific initiatives outlined include 5S discipline, waste reduction, visual factory layouts, performance tracking, and training programs.
Transforming Technology Transfer and Recipe Management: From Spreadsheets to ...guest070fdd
Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality.
Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing.
This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.
This document discusses technology transfer in the pharmaceutical industry. It begins by defining technology transfer as the process of applying technology developed in one organization or context to another. It then discusses the various aspects, types, and classifications of technology. The document focuses on the steps and processes involved in technology transfer for pharmaceutical development, including the research, development, and production phases. It outlines the key documentation and plans required for successful technology transfer, including development reports, specifications, transfer plans, and reports. The document emphasizes that effective communication and validation are important for technology transfer to ensure quality and consistency across organizations.
1) The document discusses research into optimizing product change processes and demand-supply chains in high-tech environments.
2) It outlines three action research cycles aimed at minimizing costs, shortening order delivery times, and reducing product change times.
3) The results of each cycle are analyzed to answer the research questions about the effects of optimizing for each factor. Positive and negative impacts are identified for each focus area.
The document provides an overview of a training module on the qualification and validation of HVAC systems used in manufacturing facilities. It discusses key concepts like commissioning, qualification, documentation requirements, design qualification, installation qualification, operational qualification, performance qualification, monitoring programs, and maintenance. The module aims to help understanding of critical issues for HVAC systems and how their proper design, installation, and maintenance can ensure the quality of pharmaceutical products manufactured.
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...MilliporeSigma
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest procss technologies wthin innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
Gewoon een handige samenvatting van de 3 constellaties van CMMI: DEV, SVC, ACQ.
Van elke constellatie wordt aangegeven welke PA's op welk maturity level behoren en in welke categorie.
Pharmaceutical Technology Transfer Best PracticesAnthony Grenier
Key Takeaways from the Technology Transfer Guidelines
• Standardize checklist for transferring product development, process development, and analytical method development knowledge
• Requirements are summarized in key deliverables and reports
The methodology involves four iterative stages: 1) Inception to scope KPIs, processes, and approach. 2) Planning categorizes processes and develops execution plans. 3) Design and implementation. 4) Rollout and control. The planning stage assesses process outsourcing, IT systems, quality, sequence, and reengineering to categorize stages and develop execution plans. The methodology aims to incrementally improve KPIs and processes across the organization through iterative stages.
NG BB 53 Process Control [Compatibility Mode]Leanleaders.org
This document provides an overview of process control concepts and tools. It discusses an 8-step process for process improvement that includes control. Control plans are important to ensure improved processes remain stable. Measurement systems should be analyzed and process capability recalculated during control. Cultural issues can impact control and force field analysis can identify drivers and restraints. Standard operating procedures, control charts, and mistake proofing are discussed as control mechanisms.
The document summarizes recent initiatives by the FDA related to pharmaceutical quality and process validation. It discusses the Critical Path Initiative, ICH Q8, Q9, and Q10 guidelines, revisions to CGMP regulations, FDA's quality system guidance, process validation approaches, and progress implementing process analytical technologies. It also notes some remaining challenges around process monitoring and validation, and data evaluation.
The document discusses qualifying critical utilities like HVAC and water systems. It provides an overview of qualification stages including process design, qualification, and continued verification. The presentation emphasizes building quality into systems through a risk-based approach and using tools like Quality by Design, Process Analytical Technology, and corrective action systems. Regulatory guidance recommends understanding processes scientifically and focusing validation on highest risk areas.
The document discusses the advantages of an integrated ERP solution for the pharmaceutical industry using Microsoft Dynamics AX. It summarizes that AX for Pharma 2012 is fully compliant with various regulatory requirements, enforces operating procedures and work practices, integrates key functionality like LIMS and plant maintenance, and supports a wide range of workflows to reduce costs and ensure consistency and compliance. The approach aims to significantly reduce implementation costs through a single team and minimizing customizations.
This document discusses drug Good Manufacturing Practices (GMPs) worldwide and generic drug product registration processes in the US and EU. It provides an overview of GMP guidelines from organizations like WHO, US FDA, EU, and others. It also summarizes the six quality systems for GMP compliance and compares inspection and batch release processes between the US and EU. Finally, it outlines the generic product registration process and common post-approval changes for both the US and EU.
The document discusses approaches for reengineering laboratory processes to accelerate business output. It provides an overview of a mini workshop focusing on scheduling in the laboratory and process mapping, particularly value stream mapping. The workshop aims to review efficiency improvement approaches, apply tools like scheduling and process mapping to a case study, and review lessons learned.
FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.
Zhejiang Qiming Biotech Co., Ltd. is a generic API manufacturer and contract development and manufacturing organization formed in 2010 through the merger of Eastbound Synopharma and the API division of Qiming Pharma. Qiming Biotech has over 17 years of experience in API and intermediate manufacturing for the pharmaceutical industry. The company utilizes a cGMP facility and experienced staff to provide custom process development and manufacturing solutions. Qiming Biotech focuses on cGMP and non-cGMP production of APIs and intermediates for pharmaceutical and veterinary clients.
The document discusses documentation requirements for ISO 9001 certification. It notes that some organizations see ISO certification as simply a way to get a certificate, but that the true value comes from implementing an effective quality management system. It emphasizes that top management must plan and implement the QMS. The document also discusses reducing documentation requirements in the revised ISO 9001 standard and taking a lean approach to documentation to avoid creating an unnecessary paperwork burden. It proposes a tiered documentation structure with a high-level quality manual at the top level and more detailed procedures, instructions, and records at lower levels.
This document discusses Just-in-Time (JIT) production systems. JIT aims to receive supplies and manufacture components just in time for the next operation, reducing inventory levels. Key aspects of JIT include selling products before manufacturing them based on customer orders, and planning production starting from the final operation backwards. The document also discusses implementing JIT through a sequence of projects to improve cost, quality, delivery time, flexibility and innovation.
This PhD dissertation examines how companies can optimize their product change process under simultaneous pressures to be lean, agile, and innovative. The research was conducted over three action research cycles with a large telecommunications supplier. Each cycle focused on minimizing one factor: costs in Cycle 1, order delivery time in Cycle 2, and product change time in Cycle 3. The results of each cycle provided insights into how optimizing for one factor impacted the product change process and identified positive and negative effects. Overall, the research aimed to develop a balanced optimization approach across multiple strategies rather than focusing on extremes of any single strategy.
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
Presented by Guillaume Plane on September 22, 2016
The document discusses strategies for achieving manufacturing excellence, including adopting a lean approach, strengthening manufacturing capabilities, and establishing world-class manufacturing processes. It emphasizes continuous improvement, quality focus, flexibility, and customer orientation. Specific initiatives outlined include 5S discipline, waste reduction, visual factory layouts, performance tracking, and training programs.
Transforming Technology Transfer and Recipe Management: From Spreadsheets to ...guest070fdd
Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality.
Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing.
This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.
This document discusses technology transfer in the pharmaceutical industry. It begins by defining technology transfer as the process of applying technology developed in one organization or context to another. It then discusses the various aspects, types, and classifications of technology. The document focuses on the steps and processes involved in technology transfer for pharmaceutical development, including the research, development, and production phases. It outlines the key documentation and plans required for successful technology transfer, including development reports, specifications, transfer plans, and reports. The document emphasizes that effective communication and validation are important for technology transfer to ensure quality and consistency across organizations.
1) The document discusses research into optimizing product change processes and demand-supply chains in high-tech environments.
2) It outlines three action research cycles aimed at minimizing costs, shortening order delivery times, and reducing product change times.
3) The results of each cycle are analyzed to answer the research questions about the effects of optimizing for each factor. Positive and negative impacts are identified for each focus area.
The document provides an overview of a training module on the qualification and validation of HVAC systems used in manufacturing facilities. It discusses key concepts like commissioning, qualification, documentation requirements, design qualification, installation qualification, operational qualification, performance qualification, monitoring programs, and maintenance. The module aims to help understanding of critical issues for HVAC systems and how their proper design, installation, and maintenance can ensure the quality of pharmaceutical products manufactured.
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...MilliporeSigma
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest procss technologies wthin innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
Gewoon een handige samenvatting van de 3 constellaties van CMMI: DEV, SVC, ACQ.
Van elke constellatie wordt aangegeven welke PA's op welk maturity level behoren en in welke categorie.
Pharmaceutical Technology Transfer Best PracticesAnthony Grenier
Key Takeaways from the Technology Transfer Guidelines
• Standardize checklist for transferring product development, process development, and analytical method development knowledge
• Requirements are summarized in key deliverables and reports
The methodology involves four iterative stages: 1) Inception to scope KPIs, processes, and approach. 2) Planning categorizes processes and develops execution plans. 3) Design and implementation. 4) Rollout and control. The planning stage assesses process outsourcing, IT systems, quality, sequence, and reengineering to categorize stages and develop execution plans. The methodology aims to incrementally improve KPIs and processes across the organization through iterative stages.
NG BB 53 Process Control [Compatibility Mode]Leanleaders.org
This document provides an overview of process control concepts and tools. It discusses an 8-step process for process improvement that includes control. Control plans are important to ensure improved processes remain stable. Measurement systems should be analyzed and process capability recalculated during control. Cultural issues can impact control and force field analysis can identify drivers and restraints. Standard operating procedures, control charts, and mistake proofing are discussed as control mechanisms.
The document summarizes recent initiatives by the FDA related to pharmaceutical quality and process validation. It discusses the Critical Path Initiative, ICH Q8, Q9, and Q10 guidelines, revisions to CGMP regulations, FDA's quality system guidance, process validation approaches, and progress implementing process analytical technologies. It also notes some remaining challenges around process monitoring and validation, and data evaluation.
The document discusses qualifying critical utilities like HVAC and water systems. It provides an overview of qualification stages including process design, qualification, and continued verification. The presentation emphasizes building quality into systems through a risk-based approach and using tools like Quality by Design, Process Analytical Technology, and corrective action systems. Regulatory guidance recommends understanding processes scientifically and focusing validation on highest risk areas.
The document discusses the advantages of an integrated ERP solution for the pharmaceutical industry using Microsoft Dynamics AX. It summarizes that AX for Pharma 2012 is fully compliant with various regulatory requirements, enforces operating procedures and work practices, integrates key functionality like LIMS and plant maintenance, and supports a wide range of workflows to reduce costs and ensure consistency and compliance. The approach aims to significantly reduce implementation costs through a single team and minimizing customizations.
This document discusses drug Good Manufacturing Practices (GMPs) worldwide and generic drug product registration processes in the US and EU. It provides an overview of GMP guidelines from organizations like WHO, US FDA, EU, and others. It also summarizes the six quality systems for GMP compliance and compares inspection and batch release processes between the US and EU. Finally, it outlines the generic product registration process and common post-approval changes for both the US and EU.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMerck Life Sciences
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
The document discusses GMP aspects of designing pharmaceutical and biotech manufacturing facilities. It provides an overview of the history and expectations of GMP regulations, describes the typical process for delivering a manufacturing facility from concept to production, and outlines some key documents involved in conceptual, basic, and detailed design of a facility, such as the Validation Master Plan.
This document provides an overview of a workshop on design space as it relates to ICH Q8, Q9, and Q10. The workshop covers key steps in developing a design space, including defining quality target product profiles, identifying critical quality attributes and critical process parameters, using risk management principles and design of experiments. It also discusses presenting design spaces in regulatory submissions and implementing design spaces through quality systems and control strategies. The goal is to facilitate understanding and discussion of design space concepts and applications.
REGULATORY AND INDUSTRY VIEWS ON QbD, SCIENTIFICALLY BASED QbD- EXAMPLES OF A...Ardra Krishna
The pharmaceutical Quantity by Design (QbD) is a systemic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quantity risk management.
QbD has been adopted by U.S Food and Drug Administration (FDA) for the discovery, development and manufacture of drugs.
Quality- by- design (QbD) is a concept introduces by the International Conference on Harmonization (ICH) Q8 guidelines.
The document discusses the new approach to process validation according to ICH Q8-Q11 guidelines. It introduces Quality by Design (QbD) principles which emphasize process and product understanding through design space and control strategies. The new approach involves three stages over the product lifecycle: process design, process qualification, and continued process verification. It focuses on collecting data from the beginning of development through commercial production to scientifically prove a consistent quality product.
Product life cycle and design for total costKobi Vider
The document discusses best practices for managing the full life cycle of products and projects. It outlines a standard life cycle structure with phases from initiation through deployment. It also lists the functional groups involved at each stage. A variety of industry standards and methods are presented for different life cycle activities, along with suggestions for how to filter and apply them as needed. Gates and reviews are recommended to monitor progress at key stages. The goal is to leverage organizational resources and methods to improve effectiveness across the entire product or project duration.
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.
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.
REGULATORY AND INDUSTRY VIEWS ON QbD (1).pptxnivedithag131
Quality by Design (QbD) is a regulatory initiative that requires designing and building quality into pharmaceutical products and manufacturing processes. QbD focuses on understanding manufacturing processes and identifying critical quality attributes through risk assessment and control strategies. Regulatory agencies like the FDA and EMA support QbD as it can facilitate more efficient regulatory reviews and manufacturing changes. Industry can benefit from QbD through reduced costs, improved yields and consistency, and timely product launches.
The document discusses a presentation on applying Quality by Design (QbD) principles for biotech and specialty pharma companies. It provides an overview of the presentation's objectives, which are to provide perspective on applying QbD during development and constructing regulatory documents in parallel with development milestones. The outline discusses drivers for QbD like ICH guidelines, incentives like more efficient change control and reduced testing, and barriers like additional costs and resistance to change.
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) 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 harmonized way.
World Class Manufacturing focuses on continual improvement in quality, cost, lead time, flexibility and customer service. It adopts concepts from Japanese manufacturing including just-in-time production, total quality control, total preventive maintenance, and computer integrated manufacturing. The goals are to reduce waste, defects, downtime and costs through standardized processes, employee involvement, and data-driven problem solving. A flexible manufacturing system allows for both batch and job production using general purpose tools, enhancing operational flexibility.
This document provides an overview of validation principles from a WHO technical report. It discusses the scope and objectives of validation, including qualification of equipment, utilities, and processes. The key aspects covered are approaches to validation, documentation requirements, and revalidation procedures.
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Gary Khoo Asia Biomfging Summit 2009 Final Presentation
1. QbD within the regulatory
framework: Current and Future
Perspectives
Asia Biomanufacturing Summit
Singapore
28 Oct 2009
Gary Khoo, PhD.
A-Bio Pharma
2. Outline
• QbD and regulatory background/ framework
• ICH Q8(R1) Update
• Current & future perspectives-
implementation and integration
• Business considerations
• Summary
2
Gary Khoo Asia Biomnaufacturing Summit 2009
3. QbD Framework:
Quality in Product Life Cycle
Product Process Scale-up & Commercial
Design Development Transfer Manufacturing
IND BLA
Clinical Phases
ICH Q8 (R) Pharmaceutical Development ICH Q11? Step 2 4Q 2009
PAT Guidance (2004)/ Process Validation Guidance (2008) draft
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality Systems
3
Adapted from Mukund Yelvigi, GMP International Workshop 2008, Mumbai Gary Khoo Asia Biomnaufacturing Summit 2009
4. QbD Framework:
What is Quality by Design?
• Science based, risk based, holistic and proactive
approach to pharmaceutical development
• Product, process understanding and process
control
4
Gary Khoo Asia Biomnaufacturing Summit 2009
5. QbD Framework:
Quality by Design: Design Space
Knowledge Space
Design Space
Control
Space
Acceptable Operating
Space
5
Ref: J Pharm Innov (2008) 3:60–68/ Bioprocess Intl. (2008) Mar 16-23 Gary Khoo Asia Biomnaufacturing Summit 2009
6. QbD Framework:
Why QdD? An FDA view point
• Hesitation to implement new, better technologies
• Little emphasis on manufacturing and its problems- high
wastage due to mistakes
• Development information empirical- inability to predict
scale-up/ roots cause of errors
• Differences in how products are regulated from region to
region
• Time consuming supplemental application for every
manufacturing change
• Dramatic increase in post-approval applications. Real
burden on FDA
• Less flexibility on the regulatory side
6
Gary Khoo Asia Biomnaufacturing Summit 2009
7. QbD Framework:
Changes in approach
Aspect Minimal Approach Enhanced QbD
Development Empirical, one variable at a time Mechanistic understanding,
multivariate understanding
Manufacturing Fixed; validation based on Adjust within design space;
Process initial full scale batches Lifecycle approach to
validation
Process controls In-process tests for go/no-go PAT tools for feed forward/
decisions feed back real time controls
Product Primary means of control Part of overall quality control
specifications strategy within design space
Control strategy Drug product quality controlled Real-time testing/ reduced
by testing (intermediate/ end end product testing
product)
Lifecycle Reactive (corrective action etc.) Preventive, continual
management improvement
7
Q8(R1) – Annex to Q8 Pharmaceutical Development, Gary Khoo Asia Biomnaufacturing Summit 2009
8. ICH Q8 Update:
Annex to Q8 Pharma (R1‐FDA/ R2 EMEA)
• 2 Part guide
– Part 1 was finalized (Step 4) in Nov 2005
– Part 2 only recently finalized (Nov 2008 –FDA/EMEA
Jun 2009)
• Part 1:Core document with baseline
expectations, optional information and regulatory
flexibility
– General principles of pharmaceutical development
– Introduce new concepts
• Part 2: Annexes act as a reference towards the
desired state and on the use if risk management
8
Robert Baum, PhRMA, Public ICH Meeting Brussels Nov 2008 Gary Khoo Asia Biomnaufacturing Summit 2009
9. ICH Q8 Update:
Updates on QbD submissions
• CMC/ Common Technical Document (CTD) sections S2
(Drug Substance) and P2 (Drug Product)
• July 2008, FDA OBP initiated pilot program for biologics.
– 10 supplements and 5 BLAs during initial phase.
• In Sep 2009, this deadline for pilot submissions
extended (increasing to 8 BLAs).
– INDs are also now included in the program.
• Mock P2 submission- Several organizations (e.g. EFPIA,
PDA) have done this with NCE.
• Latest PDA meeting (Frankfurt, 22-23 Sep 2009)
presented a Mock P2 based on an antibody process
9
FDA Federal Register: September 17, 2009 (Volume 74, Number 179) Page 47806-47807 Gary Khoo Asia Biomnaufacturing Summit 2009
10. ICH Q8 Update:
Q&A Release April 2009
• Establishing design space or using real time
release testing is not necessarily expected
• Design space:
– multivariate interactions not necessary if justified
– can be applicable to scale-up
– can be applicable to site-change
– can be developed over a single unit operation or a
series of unit operations
– Existing products are exempted but may be useful
• Control Strategy:
– systematic science and risk-based approach for
controls rather than narrow ranges
– control strategies exist even without a design space
10
June 2009 (EMEA/CHMP/ICH/265145/2009) Gary Khoo Asia Biomnaufacturing Summit 2009
11. Current/Future Perspectives:
Key steps for the implementation of QbD
Identify TPP
Identify CQA
11
A. Rathore and H Winkle; Nature Biotechnology vol 27, Jan 2009, 26-34 Gary Khoo Asia Biomnaufacturing Summit 2009
12. Current/Future Perspectives:
Critical Implementation strategy
• Target Product Profile: dosage, pK, half-life, safety profile,
sterility, immunogenicity
• Critical Quality Attributes: What protein attributes give rise
to target product profile.
• Defining product design space:
– Clinical design space
– Non-clinical studies and data
• Defining process design space
– Risk analysis, designed experiments, execution and analysis
– How are the CQAs created in the process?
• Refining product design space based on what is achievable
robustly (Scaled down models)
12
Gary Khoo Asia Biomnaufacturing Summit 2009
13. Current/Future Perspectives:
“Holistic” vs “unit operation” approach
• QbD for all unit operations necessary?
• Identify critical process steps based on efficacy
and purity (evidence based)
• Risk based approach
Upstream- Sa
fermentation/cell culture fe ty/
Pu
rity
Eff Capture
ica
cy/
Po
t en
cy
Polishing
13
Gary Khoo Asia Biomnaufacturing Summit 2009
14. Current/Future Perspectives:
Form An Integrated Team‐ Genentech Model
Biologics
Biologics Process Devt Commercial
Process
Process & Medium Scale scale production Fill & Finish
Research
Research production
2000lL – 20,000L
<10L
<10L 10L‐500L
• New cell line • Process development, • Process scale up • Vial filling, packing
development optimisation, scale‐up • DS Manufacturing facility • Lyophilization
• Expression • Productivity enhancement operations • Supply chain operations
engineering • QbD, PAT implementation • COGS improvement • COGS improvement
• Media design • Product quality & stability • Lean manufacturing • Lean manufacturing
• Novel product
FUNCTIONAL EXCELLENCE
ONE CMC TEAM
CELL CULTURE ANALYTICS PURIFICATION
•Analytical Biochemists •Chromatographers FORMULATION
•Molecular Biologists
•Biophysical Chemists •Protein Biochemists •Formulation chemists
•Microbiologists
•Protein Biochemists •Biochemical Engineers •Protein Biochemists
•Cell Biologists
•Engineers
•Virologists 14
Taken from Patrick Yang, Genentech, Inc., Nov. 5, 2007, APBioCheDSC, Taiwan. Gary Khoo Asia Biomnaufacturing Summit 2009
16. Business Considerations
• Enhanced process and product understanding
• Smoother transfers between R&D and
manufacturing
• Fewer manufacturing failures
• Broad spectrum of industry implementation
• CMC Post-Approval Change Management could
be a major factor for implementing QbD
• Will Q8, Q9, Q10 (Q11) remain optional or
become a regulatory expectation?
16
Robert Baum, Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Gary Khoo Asia Biomnaufacturing Summit 2009
Meeting, Maryland, Aug 2009
17. Business considerations
• How will products made with the minimal approach fair
against “QbD” products (regulatory submissions/
“consumer perception”)?
• Different manufacturing expectations, control
procedures, etc.
– put new requirements on supply chain/quality
– Justification for greater resources to incorporate QbD
• Uncertainty over timing of and investment requirements
for QbD implementation
• How to manage QbD with Alliance Partners, CROs and
Suppliers?
• Design quality into manufacturing processes- how will
the management of each site be managed?
17
Robert Baum, Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Gary Khoo Asia Biomnaufacturing Summit 2009
Meeting, Maryland, Aug 2009
18. Business Considerations:
Who can afford QbD?
Big
Pharma
model
Small
Biotech
model
18
Taken from Paul McKenzie Bioproduction Forum Sep 2009 Gary Khoo Asia Biomnaufacturing Summit 2009
19. Summary
• QbD has evolved, is still evolving with better
understanding of its implementation
• Have a macroscopic view about it’s
implementation and key requirements within
the regulatory framework
• QbD is still optional but it can benefit
business in long term
• QbD starts early; competent partners and
CMOs can make a difference
19
Gary Khoo Asia Biomnaufacturing Summit 2009