This document discusses the new quality paradigm in pharmaceuticals which emphasizes building quality in from the beginning through a systematic quality by design (QbD) approach. It outlines the key elements of QbD including establishing a quality target product profile, identifying critical quality attributes, understanding material attributes and process parameters that impact critical quality attributes through risk assessment, developing a design space, and implementing a control strategy. The new paradigm focuses on science-based approaches, quality risk management, robust quality systems, and an integrated approach across the product lifecycle between industry and regulators.
The document discusses the Master Formula Record (MFR), which contains all information about the manufacturing process for a pharmaceutical product. It is prepared by the research and development team and used as a reference standard for preparing batch manufacturing records. The MFR includes details like product name, ingredients, batch size, manufacturing process steps, packaging process, and expected yields. It provides standardized instructions for consistently producing batches of a product.
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 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.
The document discusses validation of pharmaceutical processes. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. There are several types of validation including process validation to ensure consistency in manufacturing, cleaning validation to minimize contamination, equipment validation to ensure equipment works correctly, and validation of analytical methods to establish test method performance. Proper documentation is essential for validation including a validation master plan, protocols, reports and standard operating procedures.
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
The document discusses the Master Formula Record (MFR), which contains all information about the manufacturing process for a pharmaceutical product. It is prepared by the research and development team and used as a reference standard for preparing batch manufacturing records. The MFR includes details like product name, ingredients, batch size, manufacturing process steps, packaging process, and expected yields. It provides standardized instructions for consistently producing batches of a product.
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 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.
The document discusses validation of pharmaceutical processes. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. There are several types of validation including process validation to ensure consistency in manufacturing, cleaning validation to minimize contamination, equipment validation to ensure equipment works correctly, and validation of analytical methods to establish test method performance. Proper documentation is essential for validation including a validation master plan, protocols, reports and standard operating procedures.
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
Validation is the process of establishing documented evidence that a process or system does what it is intended to do. There are three main types of validation: process validation, cleaning validation, and equipment validation. Process validation involves collecting data throughout production to prove a process can consistently deliver quality products. It can be done prospectively, concurrently, or retrospectively. Cleaning validation ensures that cleaning processes minimize cross-contamination. Equipment validation proves equipment works correctly. Validation protocols specify the validation activities and acceptance criteria. The key phases of validation are prevalidation qualification, process validation, and validation maintenance.
This document discusses quality risk management (QRM) in the pharmaceutical industry. It begins by introducing QRM and its importance in ensuring quality systems. The document then outlines the scope of QRM, including its application across various stages of drug development and manufacturing. The core principles and process of QRM are described, including risk assessment, control, communication, and review. Various risk management tools are also introduced. Finally, the document discusses integrating QRM into industry and regulatory operations to facilitate consistent decision making.
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. The quality guidelines cover stability testing, analytical validation, impurities, Good Manufacturing Practice, and quality risk management. Together, the ICH guidelines aim to harmonize technical requirements across regions to provide efficient drug development and approval.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
Quality control test for packaging material ,qc test for glass,metal,rubberKunalPatel257
This document describes quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It provides details on tests for glass, plastic, and metal containers to evaluate properties like chemical resistance, leakage, hydrolytic resistance, and thermal shock resistance. Tests for closures examine sterility, fragmentation, self-sealability, pH, and absorption. Secondary packaging materials are tested for moisture content, folding endurance, air permeability, tensile strength, and burst resistance. The document provides testing methodologies and acceptance limits for ensuring packaging integrity and suitability for drug products.
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
Technology transfer involves the systematic transfer of a technology from research and development to production. It requires a technology transfer team consisting of representatives from R&D, quality assurance, production, engineering and quality control. The technology transfer process involves multiple stages, beginning with development of the technology in R&D. R&D then provides a technology transfer dossier to production with documentation including the master formula, manufacturing instructions, specifications and analytical methods. Successful technology transfer depends on open communication between both the sending and receiving units.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
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 document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. It provides an introduction to ICH, the need for harmonization, the origin and evolution of ICH, its objectives and members. It then describes the process of ICH harmonization and provides examples of ICH guidelines related to quality, safety, efficacy, and multidisciplinary topics. The quality guidelines address stability testing, impurities thresholds, and good manufacturing practices.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part II in the series- deals with the concepts of Quality Target Product Profile and Critical Quality attributes.This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part VI in the series- deals with the concepts of Design of Experiments. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Validation is the process of establishing documented evidence that a process or system does what it is intended to do. There are three main types of validation: process validation, cleaning validation, and equipment validation. Process validation involves collecting data throughout production to prove a process can consistently deliver quality products. It can be done prospectively, concurrently, or retrospectively. Cleaning validation ensures that cleaning processes minimize cross-contamination. Equipment validation proves equipment works correctly. Validation protocols specify the validation activities and acceptance criteria. The key phases of validation are prevalidation qualification, process validation, and validation maintenance.
This document discusses quality risk management (QRM) in the pharmaceutical industry. It begins by introducing QRM and its importance in ensuring quality systems. The document then outlines the scope of QRM, including its application across various stages of drug development and manufacturing. The core principles and process of QRM are described, including risk assessment, control, communication, and review. Various risk management tools are also introduced. Finally, the document discusses integrating QRM into industry and regulatory operations to facilitate consistent decision making.
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. The quality guidelines cover stability testing, analytical validation, impurities, Good Manufacturing Practice, and quality risk management. Together, the ICH guidelines aim to harmonize technical requirements across regions to provide efficient drug development and approval.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
Quality control test for packaging material ,qc test for glass,metal,rubberKunalPatel257
This document describes quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It provides details on tests for glass, plastic, and metal containers to evaluate properties like chemical resistance, leakage, hydrolytic resistance, and thermal shock resistance. Tests for closures examine sterility, fragmentation, self-sealability, pH, and absorption. Secondary packaging materials are tested for moisture content, folding endurance, air permeability, tensile strength, and burst resistance. The document provides testing methodologies and acceptance limits for ensuring packaging integrity and suitability for drug products.
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
Technology transfer involves the systematic transfer of a technology from research and development to production. It requires a technology transfer team consisting of representatives from R&D, quality assurance, production, engineering and quality control. The technology transfer process involves multiple stages, beginning with development of the technology in R&D. R&D then provides a technology transfer dossier to production with documentation including the master formula, manufacturing instructions, specifications and analytical methods. Successful technology transfer depends on open communication between both the sending and receiving units.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
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 document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. It provides an introduction to ICH, the need for harmonization, the origin and evolution of ICH, its objectives and members. It then describes the process of ICH harmonization and provides examples of ICH guidelines related to quality, safety, efficacy, and multidisciplinary topics. The quality guidelines address stability testing, impurities thresholds, and good manufacturing practices.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part II in the series- deals with the concepts of Quality Target Product Profile and Critical Quality attributes.This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part VI in the series- deals with the concepts of Design of Experiments. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
This document discusses guidelines for handling Out of Specification (OOS) test results in the pharmaceutical industry. It provides an overview of the history of OOS guidelines, including FDA audits in the 1980s-90s that identified issues like "testing until pass", which led the FDA to publish formal OOS guidelines in 2006. The document outlines the OOS investigation process, which should first thoroughly check for laboratory errors and assign a cause, then may proceed to extended investigations including retesting or plant investigations if no error is found. Tools like 5M analysis and the five whys technique can be used to identify and analyze the root cause.
This document discusses key concepts of quality in healthcare including definitions, dimensions, and frameworks. It defines quality as meeting expectations and conforming to standards. The dimensions of quality - effectiveness, efficiency, safety, patient-centeredness, timeliness, and more - must be achieved to provide the right care. Quality is measured using a structure-process-outcome framework where structure leads to processes which lead to outcomes. Total quality management is presented as the latest approach focusing on continuous improvement, customer satisfaction, and organizational commitment to quality.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part IV in the series- deals with the concepts of Design Space, Design of experiments and Models. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Introduction au développement chimique pharmaceutiqueDiolez Christian
Partie du cours de Mr Christian Diolez Expert consultant en chimie organique et développement chimique pharmaceutique donné à l'école de chimie de Rennes
Mots clés: Chimie, développement chimique, cours, principe actif, chimie organique, sécurité, cGMP, ICH,
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part III in the series- deals with the concepts of critical material attributes, critical process parameters , their linage to the the critical Quality attributes of the Product and Quality Risk Management and its pivotal role in the QbD process.Concepts of control strategy are also discussed briefly.
This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part V in the series- deals with the concepts of Control strategy and PAT. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
This document discusses guidelines for assessing elemental impurities in pharmaceutical products according to ICH Q3D. It describes a risk-based approach to evaluating potential sources of elemental impurities from drug substances, excipients, equipment and processing aids. Specific approaches are provided for assessing impurities from metal catalysts, water sources, and packaging materials. The presentation emphasizes controlling impurities through an understanding of manufacturing processes and applying appropriate testing and control strategies.
Role of quality by design (qb d) in quality assurance of pharmaceutical productNitin Patel
This document discusses the role of Quality by Design (QbD) in assuring quality of pharmaceutical products. It defines QbD and compares the traditional quality assessment system to the QbD approach. The document outlines the steps of a QbD program, including defining target quality profiles, identifying critical quality attributes and process parameters, designing the manufacturing process and establishing a control strategy. It also discusses tools used in QbD like design of experiments and risk assessment.
The document discusses basic quality concepts and terminology related to quality assurance and management. It defines key terms like quality, reliability, maintainability, supplier, customer, quality policy, quality management, quality system, quality control, and quality assurance. It also discusses how quality assurance aims to encourage individual responsibility and getting work right the first time to minimize rework. Quality costs and benefits are examined, noting how quality construction can reduce costs from replacements, delays, and disputes while increasing goodwill and lowering maintenance costs.
Six sigma is a statistical approach to process improvement that aims to reduce defects. It was developed by Motorola in the 1970s to improve quality. The six sigma method includes phases such as Define, Measure, Analyze, Improve, and Control to identify and remove defects in processes. It uses statistical tools and follows a DMAIC or DMADV model. While six sigma aims to improve processes and reduce defects, some critics argue it is more focused on appraisal than prevention and does not always yield quality improvements.
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.
The document discusses Quality by Design (QbD) in pharmaceutical manufacturing. It defines QbD as a systematic approach to development that emphasizes product and process understanding through design and control based on science and risk management. The key goals of QbD are to develop quality products based on clinical performance, increase process capability, and enhance manufacturing efficiencies. QbD involves defining quality targets, understanding critical materials and processes, and establishing a control strategy to consistently meet quality standards.
This document summarizes a research article about Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. Some key points:
1) QbD aims to develop robust processes to consistently deliver quality products by understanding critical quality attributes and controlling variables throughout the product lifecycle.
2) International guidelines like ICH Q8, Q9, and Q10 provide a framework for QbD implementation and its benefits like reduced regulatory oversight and manufacturing flexibility.
3) The QbD approach involves defining a quality target product profile, identifying critical quality attributes, understanding material and process impacts through risk assessment, and implementing a control strategy within
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.
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.
This document summarizes ICH Q8 guidelines for pharmaceutical product development. It discusses key aspects of quality by design (QbD) like quality target product profiles, critical quality attributes, and critical process parameters. The document also outlines the contents recommended for the quality module in a common technical document, including drug substances, excipients, formulation development, manufacturing processes, containers and closures, microbiological attributes, and compatibility studies. The goal of QbD and ICH Q8 is to build quality into pharmaceutical products through scientific approaches and risk management during development.
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...Bachu Sreekanth
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. It aims to enhance drug quality and supply to consumers. The QbD process involves gathering prior knowledge, designing formulations and processes, identifying critical quality attributes, establishing control strategies, and continually monitoring and improving processes. QbD provides benefits like reduced batch failures, more efficient control of changes, and opportunities for more flexible regulatory approaches.
This 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.
This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
A Review on Quality by Design and its Approachesijtsrd
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.
The Pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
Quality cannot be tested into products; it has to be built in by design.
The 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 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.
The document summarizes ICH Q8 guidelines for pharmaceutical product development using a Quality by Design (QbD) approach. It discusses key QbD concepts like quality target product profiles, critical quality attributes, critical process parameters, and design space. The guidelines suggest determining aspects of drug substances, excipients, manufacturing processes, and container closure systems that are critical to quality. They provide guidance on contents for drug product development documentation, including formulation development, compatibility studies, container closure selection, and ensuring microbiological attributes and stability. The QbD approach aims to build quality into pharmaceutical products from the design stage through understanding and control of material and process variables.
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.
This document summarizes guidelines for analytical method validation from a presentation by the non-profit organization "Drug Regulations". Key points include: analytical methods must be validated for their intended use; validation should demonstrate accuracy, precision, specificity, linearity, range and robustness; changes may require revalidation; and transfer between labs requires verification to ensure equivalent performance.
This presentation summarizes recommendations from an ISPE working group for assessing blend and content uniformity. The group proposed modifications to address issues with the withdrawn 2002 FDA guidance. Key recommendations include a two-stage blend testing approach using statistical analysis and flexibility in selecting sampling plans, acceptance criteria, and confidence/coverage levels using a risk-based approach.
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
This document provides guidance for preparing a laboratory information file (LIF) according to World Health Organization guidelines. A LIF contains information about the operations, quality management, personnel, equipment, and procedures of a testing laboratory. It describes the laboratory's activities, policies, and supporting documentation in a succinct manner not exceeding 30 pages. The guidance outlines the key information that should be included in each section of a LIF.
This presentation provides information from the FDA document "QUALITY METRICS TECHNICAL CONFORMANCE GUIDE". It outlines 27 data elements for reporting quality metrics to the FDA, including information like drug name, application type, test results, complaints, and establishment details. The goal is to help ensure clear expectations for submitting quality metric data to support the FDA's objectives of ensuring safe, high-quality drug production.
This document provides an overview of quality risk management and failure mode and effects analysis (FMEA). It discusses risk as a combination of the probability of harm occurring and the severity of that harm. The quality risk management process includes risk identification, analysis, evaluation, control, and communication. FMEA is presented as a systematic method to identify and prevent product and process problems before they occur. Key aspects of FMEA covered include failure modes, effects, risk priority numbers, and using FMEA to prioritize risks for improvement actions. Scales for rating severity, occurrence, detection, and examples of applying FMEA to a drying process are also presented.
This presentation provides information on computerized system validation from the World Health Organization (WHO). It discusses the purpose and principles of validation to ensure performance of computer systems. Key points covered include validation protocols and reports, evaluating vendor systems, requirements specifications, functional specifications, and maintaining validated systems. The presentation is intended to provide pharmaceutical professionals with latest guidance on computerized system validation.
This document provides guidance on validation and qualification principles from the World Health Organization (WHO). It discusses the need for validation and qualification activities to ensure product quality, safety, and efficacy throughout the product lifecycle. Key aspects covered include definitions of validation terms, approaches to validation planning, and documentation requirements such as a validation master plan and protocols.
This presentation is compiled by Drug Regulations, a nonprofit organization that provides online pharmaceutical resources. It discusses FDA guidance on data integrity and compliance with cGMP regulations. The guidance clarifies FDA's expectations around the creation and handling of data to ensure its reliability and accuracy according to cGMP standards.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation provides information on minimizing contamination from human personnel in cleanrooms. It discusses how human skin naturally hosts many microorganisms and how cleanroom garments and practices aim to contain these microbes. Proper gowning techniques and high-quality, tightly woven fabrics are important to limit contamination from the billions of skin cells shed daily and prevent microbes from reaching sensitive products. Understanding the human microbiome helps improve strategies to exclude microorganisms from all body areas.
The document provides guidance on technology transfer between pharmaceutical manufacturing sites. It discusses that technology transfer requires a documented, planned approach with trained personnel and quality systems. A successful transfer involves the sending unit providing documentation to the receiving unit, conducting training, and jointly executing a transfer protocol. The receiving unit must demonstrate it can routinely reproduce the product or process to specifications. The guidance addresses general principles, planning, information to be transferred for active pharmaceutical ingredients and excipients, process validation, and assessing a successful transfer.
This document provides guidance on preparing a site master file (SMF) for pharmaceutical manufacturing sites. It outlines the key information that should be included in an SMF, such as descriptions of quality management systems, personnel, facilities, equipment, production, quality control, distribution, and procedures for complaints and recalls. The SMF is intended to provide regulatory authorities with information on GMP compliance during inspections.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
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share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
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Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Cell Therapy Expansion and Challenges in Autoimmune Disease
Quality by Design
1. The New Quality Paradigm
Introduction
1
Presentation prepared by Drug Regulations – a not for
profit organization. Visit www.drugregulations.org for
the latest in Pharmaceuticals.
23-09-2015
2. This presentation is compiled from freely
available resource like the website of FDA, EMA
and ICH .
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
9/23/2015 2
Drug Regulations : Online
Resource for Latest Information
4. Quality
◦ The suitability of either a drug substance or a drug
product for its intended use. This term includes
such attributes as the identity, strength, and purity
(ICH Q6A)
423-09-2015
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6. Quality by Design
◦ 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
623-09-2015
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9. Pharmaceutical Development (Q8)
Past: Data transfer / Variable output
Present: Knowledge transfer / Science
based / Consistent output
Pharmaceutical Quality Systems (Q10)
Past: GMP checklist
Future: Quality Systems across product
life cycle
Quality Risk Management (Q9)
Past: Used, however poorly defined
Present: Opportunity to use structured
process thinking
Changed
ParadigmQ9
923-09-2015
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10. Science is no longer isolated; it is living
across the lifecycle of the product/process
within a Quality Management System
1023-09-2015
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11. The new paradigm emphasize:
1. Quality must be mainly built in and it will not improve
by additional testing and inspection
2. Better utilization of modern science throughout
product lifecycle
3. QRM is a key enabler throughout product lifecycle
4. Robust PQS, with appropriate knowledge management,
assures quality throughout product life cycle
5. An integrated approach to development,
manufacturing and quality for both industry and
regulators
1123-09-2015
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12. CQA’s
Product Profile
Risk Assessments
Design Space
Control Strategy
Continual
Improvement
12
Identify
CQA
Identify
CMA &
CPP
Quality
Target
Product
Profile
What is
critical to
the
Patient
QRM
PAT
Design space Control Strategy
SOP PAT
PAT ,
RTRT
PAT RTRT
23-09-2015
13. What are the elements of
QbD?
Define desired
product performance
upfront;
identify product CQAs
Design formulation and
process to meet
product CQAs
Understand impact of
material attributes and
process parameters on
product CQAs
Identify and control
sources of variability
in material and
process
Continually monitor
and update
process to assure
consistent quality
Risk assessment and risk control
Product & process design and development
Quality
by
Design
1323-09-2015
14. • Quality Target product profile
• Determine critical quality attributes
(CQAs)
• Risk assessment: Link raw material
attributes and process parameters to
CQAs
• Develop a design space.(Optional not required)
• Design and implement a control strategy
• Manage product lifecycle, including
continual improvement
Product
profile
CQAs
Risk
assessment
Design
space
Control
strategy
Continual
Improvement
Essential Elements in a QbD
Approach (Q8R2)
1423-09-2015
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15. Product
Distribution
Product
Quarantine
Fixed
Packaging
Process
Fixed, Batch
Manufacturing
Process
Product
Development
Release Testing,
Document
Integrity
In-process
Testing,
Documentation
In-process
Testing,
Documentation
Fixed
Parameters,
Ranges
PatientProduction
System
Quality
System
As-Is: Traditional Pharmaceutical Product Supply System
Product
Distribution
Variable Pkg
Process
Variable Batch
or Continuous
Mfg Process
Product
Development
Real-time
Release
Maintain in Design Space
(PAT, etc.)
Design Space,
Variable
Parameters
PatientProduction
System
Quality
System
To-Be: QbD Pharmaceutical Product Supply System
Product
Distribution
Product
Quarantine
Fixed
Packaging
Process
Fixed, Batch
Manufacturing
Process
Product
Development
Release Testing,
Document
Integrity
In-process
Testing,
Documentation
In-process
Testing,
Documentation
Fixed
Parameters,
Ranges
PatientProduction
System
Quality
System
As-Is: QbT Pharmaceutical Product Supply System
Product
Distribution
Responsive Pkg
Process
Responsive
Batch or
Continuous
Mfg Process
Product
Development
Real-time
Release
Control Strategy: Maintain
in Design Space (PAT, etc.)
Design Space
PatientProduction
System
Quality
System
To-Be: QbD Pharmaceutical Product Supply System
15
23-09-2015
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17. • Quality Target product profileProduct
profile
CQAs
Risk
assessment
Design
space
Control
strategy
Continual
Improvement
Essential Elements in a QbD
Approach (Q8R2)
1723-09-2015
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18. 18
Dissolution ?
Dose ?
Content
Uniformity ? Hardness ?
Appearance ?
Quality Target Product Profile
Identify what is
critical to the patient
and
link this to the drug
product
23-09-2015
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19. A prospective summary of
the quality characteristics of
a drug product that ideally
will be achieved to ensure the
desired quality, taking into
account safety and efficacy of
the drug product : ICH Q8
(R2)
1923-09-2015
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20. 20
By beginning with the end in
mind, the result of development
is a robust formulation and
manufacturing process with an
acceptable control strategy that
ensures the performance of the
drug product
23-09-2015
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21. QTPP Element Target Justification
Dosage Form MR Tablet Pharmaceutical equivalence
requirement: Same dosage form
Route of Administration Oral Pharmaceutical equivalence
requirement: Same route of
administration
Dosage Strength 10 mg Pharmaceutical equivalence
requirement: Same strength
Pharmacokinetics Fasting Study and
Fed Study
90 % confidence
interval of the PK
parameters, AUC0-
2, AUC2-24,
AUC0-∞ and
Cmax, should fall
within
bioequivalence
limits
Bioequivalence requirement
Initial plasma concentration through
the first two hours that provides a
clinically significant therapeutic
effect followed by a sustained plasma
concentration that maintains the
therapeutic effect
2123-09-2015
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22. QTPP Element Target Justification
Stability At least 24-month
shelf-life at room
temperature
Equivalent to or better than RLD
shelf-life
Drug product quality
attributes
Physical attributes
Pharmaceutical equivalence
requirement: Meeting the same
compendial or other applicable
(quality) standards (i.e., identity,
assay, purity, and quality)
Identification
Assay
Content Uniformity
Degradation products
Residual solvents
Drug release
Microbial Limits
Water Content
2223-09-2015
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23. QTPP Element Target Justification
Container Closure System Suitable container
closure system to
achieve the target
shelf-life and to
ensure tablet
integrity during
shipping
HDPE bottles with Child Resistant
(CR) Caps are selected based on
similarity to the RLD packaging. No
further special protection is needed
due to the stability of drug substance
Z.
Administration/concurrence
with labeling
A scored tablet
can be divided into
two 5 mg tablets. Information is provided in the RLD
labeling
The tablet can be
taken without
regard to food (no
food effect).
Alternative methods of
administration
None
None are listed in the RLD labeling.
2323-09-2015
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24. • Quality Target product profile
• Determine critical quality attributes
(CQAs)
Product
profile
CQAs
Risk
assessment
Design
space
Control
strategy
Continual
Improvement
Essential Elements in a QbD
Approach (Q8R2)
2423-09-2015
25. A CQA is a physical, chemical, biological, or
microbiological property or characteristic that
should be within an appropriate limit, range, or
distribution to ensure the desired product
quality. (ICH Q 8 R2)
CQAs are generally associated with the
◦ Drug substance,
◦ Excipients,
◦ Intermediates (in-process materials) and
◦ Drug product.
2523-09-2015
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26. 26
Q T P P
Potential
Impact to
Safety
Efficacy &
Quality?
Non - Critical
Severity@ Critical
Low Risk
High risk
Continual Improvement iteration
@ A Severity Scale is used to assess
relative magnitude of impact. A
change in criticality only occurs w/
a change in severity.
No
Yes
23-09-2015
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28. • Quality Target product profile
• Determine critical quality attributes
(CQAs)
• Risk assessment: Link raw material
attributes and process parameters to
CQAs
Product
profile
CQAs
Risk
assessment
Design
space
Control
strategy
Continual
Improvement
Essential Elements in a QbD
Approach (Q8R2)
2823-09-2015
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29. Material: raw materials, starting materials, reagents,
solvents, process aids, intermediates, APIs, and packaging
and labelling materials, ICH Q7A
Attribute: A physical, chemical, biological or
microbiological property or characteristic
Material Attribute: Can be an excipient CQA, raw material
CQA, starting material CQA, drug substance CQA etc
◦ A Material Attribute can be quantified
◦ Typically fixed
◦ Can sometimes be changed during further processing (e.g. PSD–
milling)
◦ Examples of material attributes: PSD, Impurity profile, porosity,
specific volume, moisture level, sterility
2923-09-2015
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30. A process parameter whose variability has an impact
on a critical quality attribute and therefore should be
monitored or controlled to ensure the process
produces the desired quality (Q8R2)
CPPs have a direct impact on the CQAs
A process parameter (PP) can be measured and
controlled (adjusted)
◦ Examples of CPPs for small molecule: Temperature,
addition rate, cooling rate, rotation speed
◦ Examples of CPPs for large molecule: Temperature, pH,
Agitation, Dissolved oxygen, Medium constituents, Feed
type and rate
3023-09-2015
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32. Critical
Material
Attributes
MA 1
MA2
Critical Process
Parameters
CPP 1
CPP 2
Critical Quality
attributes
CQA 1
CQA 2
CQA 3
Understand & control the variability of
Material attributes and critical process
parameters to meet Product CQA’s.
3223-09-2015
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33. Two primary principles:
The evaluation of
the risk to quality
should be based on
scientific knowledge
and ultimately link
to the protection
of the patient
The level of effort,
formality and
documentation
of the quality risk
management process
should be
commensurate with the
level of risk
ICH Q9
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36. Describes systematic processes for the
assessment, control, communication and review
of quality risks
Applies over product lifecycle: development,
manufacturing and distribution
Includes principles, methodologies and examples
of tools for quality risk management
Assessment of risk to quality should:
◦ Be based on scientific knowledge
◦ Link to the protection of the patient
◦ Extend over the lifecycle of the product
3623-09-2015
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37. Risk Review
RiskCommunication
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
Initiate Quality
Risk Management Process
Output / Result of the Quality
Risk Management Process
RiskManagementtools
Failure Mode Effects Analysis (FMEA)
◦ Break down large complex processes into manageable steps
Failure Mode, Effects and Criticality Analysis (FMECA)
◦ FMEA & links severity, probability & detectability to criticality
Fault Tree Analysis (FTA)
◦ Tree of failure modes combinations with logical operators
Hazard Analysis and Critical Control Points (HACCP)
◦ Systematic, proactive, and preventive method on criticality
Hazard Operability Analysis (HAZOP)
◦ Brainstorming technique
Preliminary Hazard Analysis (PHA)
◦ Possibilities that the risk event happens
Risk ranking and filtering
◦ Compare and prioritize risks with factors for each risk
CONSIDERATIONS
3723-09-2015
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39. A material attribute or process parameter is
critical when a realistic change in that
attribute or parameter can significantly
impact the quality of the output material
3923-09-2015
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40. 40
• A Process Parameter is a
Critical Process Parameter
when it has a high impact
on a CQA
• CPPs are responsible for
ensuring the right CQA
• CPPs are identified from a
list of potential CPPs, (i.e.
PPs) using risk assessment
and experimental work
CPP
PP
PP
High Impact
Low Impact
CQA
23-09-2015
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41. Drug Substance Attributes
Drug
Product
C Q A
Solid
State
Form
P S D Hygrosc
opicity
Solubil
ity
Mois
ture
Cont
ent
Residual
Solvent
Process
Impurit
ies
Chemi
cal
stabili
ty
Flow
prop
Assay Low Med Low Low Low Low Low High Med
C U Low High Low Low Low Low Low Low High
Dissolution High High Low High Low Low Low Low Low
Degradation
products
Med Low Low Low Low Low Low High Low
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42. Drug Substance
Attributes
Drug Product
CQA’s
Justification
Solid state form
Assay Drug substance solid state form does not affect tablet
assay. The risk is low.
Content
Uniformity
Drug substance solid state form does not affect tablet
CU. The risk is low.
Dissolution Different polymorphic forms of the drug substance
have different solubility and can impact tablet
dissolution. The risk is high.
Acetriptan polymorphic Form III is the most stable form
and the DMF holder consistently provides this form. In
addition, pre-formulation studies demonstrated that
Form III does not undergo any polymorphic conversion
under the various stress conditions tested. Thus,
further evaluation of polymorphic form on drug product
attributes was not conducted.
Degradation
Products
Drug substance with different polymorphic forms may
have different chemical stability and may impact the
degradation products of the tablet. The risk is medium
4223-09-2015
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43. • Quality Target product profile
• Determine critical quality attributes
(CQAs)
• Risk assessment: Link raw material
attributes and process parameters to
CQAs
• Develop a design space.(Optional not required)
Product
profile
CQAs
Risk
assessment
Design
space
Control
strategy
Continual
Improvement
Essential Elements in a QbD
Approach (Q8R2)
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44. Definition
◦ The multidimensional combination and interaction
of input variables (e.g., material attributes) and
process parameters that have been demonstrated
to provide assurance of quality
Regulatory flexibility
◦ Working within the design space is not considered
a change
Important to note
◦ Design space is proposed by the applicant and is
subject to regulatory assessment and approval
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45. First-principles approach
◦ Combination of experimental data and mechanistic
knowledge of chemistry, physics, and engineering to model
and predict performance
Non-mechanistic/empirical approach
◦ statistically designed experiments (DOEs)
◦ linear and multiple-linear regression
Scale-up correlations
◦ translate operating conditions between different scales or
pieces of equipment
Risk Analysis
◦ determine significance of effects
Any combination of the above
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46. 40
50
600
1
2
50.0
55.0
60.0
65.0
70.0
75.0
80.0
85.0
90.0
95.0
100.0
Dissolution(%)
Parameter 1
Param
eter 2
40 42 44 46 48 50 52 54 56 58 60
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
Dissolution (%)
Parameter 1
Parameter2
90.0-95.0
85.0-90.0
80.0-85.0
75.0-80.0
70.0-75.0
65.0-70.0
60.0-65.0
Surface Plot Contour Plot
Design Space
(non-linear)
Design Space
(linear ranges)
• Design space proposed by the applicant
• Design space can be described as a mathematical function or
simple parameter range
• Operation within design space will result in a product meeting the
defined quality attributes
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48. A planned set of controls,
◦ derived from current product and process
understanding,
◦ that assures
process performance and product quality.
The controls can include
◦ parameters and attributes related to
drug substance,
drug product materials ,
components, facility ,
equipment operating conditions,
in-process controls,
finished product specifications, and
the associated methods and frequency of monitoring and
control (ICH 10).
4823-09-2015
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49. Design Space and
Quality Control Strategy
Process
(or Process Step)
Design
Space
Monitoring of
Parameters
or Attributes
Process Controls/PAT
Input
Process
Parameters
Input
Materials
Product
(or Intermediate)
Product
Variability
Reduced
Product
Variability
Process
Variability
4923-09-2015
50. 50
Assay (HPLC)
Purity, related
impurities, ((HPLC)
Residual solvent (GC)
Moisture content (KF)
Heavy Metals
Etc…
ID, Assay, CU (HPLC)
Purity, ((HPLC)
Dissolution,
Appearance
Moisture content (KF)
Etc
NIR, at-line (id
raw materials)
NIR, on-line
(reaction id)
IR, on-line
(purity, assay)
FBRM, on-
line (PSD)
NIR, on-line
(Moisture, purity
NIR, at-line (id raw
materials)
NIR, on-line, blend
homogeneity
NIR, on-line
(assay, CU, ID)
NIR, on-line, blend
homogeneity
ConventionalTesting
23-09-2015
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51. ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
slide 51
Breakout C: Pharmaceutical Quality System
Inputs
• Manufacturing
Experience
• Deviations / CAPA
• Performance
Monitoring
• Customer
Complaints
• Management
Reviews
• Material Variance
Product Lifecycle
Adjustment
• Readily achieved as
part of routine
feedback
• Require permanent
& substantial
process/facility
design to improve
original concept
Continual
Improvement
Expanded
Body of Knowledge
Feed Forward
Feedback
Product Lifecycle
Management
Continual Improvement of the Product
23-09-2015
52. Aspect Minimal Approaches Enhanced, Quality by Design
Approaches
Overall
Pharmaceutical
Development
• Mainly empirical
• Developmental
research often
conducted one
variable at a Time
• Systematic, relating
mechanistic understanding
of material attributes and
process parameters to
drug product CQAs
• Multivariate experiments
to understand product and
process
• Establishment of design
space
• PAT tools utilised
5223-09-2015
53. Process flow:
Screening
Optimization
Validation
Identification of significant parameters
Finding parameter ranges
Finding interactions of parameters
Defining models
Production
Identification of CPP
Continuous monitoring
and development
Characterization range
Acceptable range
Operating range
Process
design space
Set point
Identification of noise factors
Process/ product Development:
Robust
Cost effective
Feasible
Defining control strategies
5323-09-2015
54. Aspect Minimal Approaches Enhanced, Quality by Design
Approaches
Manufacturing
Process
• Fixed
• Validation primarily
based on initial full-
scale batches
• Focus on
optimisation and
reproducibility
• Adjustable within design
space
• Lifecycle approach to
validation and, ideally,
• continuous process
verification
• Focus on control strategy
and robustness
• Use of statistical process
control methods
5423-09-2015
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55. Aspect Minimal Approaches Enhanced, Quality by Design
Approaches
Process
Controls
• In-process tests
primarily for
• go/no go decisions
• Off-line analysis
• PAT tools utilised with
appropriate feed
• forward and feedback
controls
• Process operations tracked
and trended to
• Support continual
improvement efforts
postapproval
Product
Specifications
• Primary means of
control
• Based on batch data
available at time of
registration
• Part of the overall quality
control strategy
• Based on desired product
performance with relevant
supportive data
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56. Aspect Minimal Approaches Enhanced, Quality by Design
Approaches
Control
Strategy
• Drug product quality
controlled primarily
by intermediates (in
process materials)
and end product
testing
• Drug product quality
ensured by risk-based
control strategy for well
understood product and
process
• Quality controls shifted
upstream, with the
possibility of real-time
release testing or reduced
end-product testing
Lifecycle
Management
• Reactive (i.e.,
problem solving and
corrective action)
• Preventive action
• Continual improvement
facilitated
5623-09-2015
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58. Why QbD?
• Higher level of assurance of product quality for
patient
o Improved product and process design and understanding
o Quality risk management in manufacturing
o Monitoring, tracking and trending of product and process
o Continual improvement
• Cost saving and efficiency for industry
o Increase efficiency of manufacturing process
o Minimize/eliminate potential compliance actions
o Provide opportunities for continual improvement
o Facilitate innovation
• More efficient regulatory oversight
o Streamline post approval manufacturing changes and
regulatory processes
5823-09-2015
59. Why QbD?
• Depending on the level of development (scientific
understanding) achieved and an adapted quality system in
place, opportunities exist to develop more flexible regulatory
approaches, for example, to facilitate:
• Risk-based regulatory decisions (reviews and inspections);
• Manufacturing process improvements, within the
approved design space described in the dossier, without
further regulatory review;
• Reduction of post-approval submissions;
• Real-time release testing, leading to a reduction of end
product release testing.
5923-09-2015
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60. Culture challenges
◦ Move from prescriptive approach
◦ More sharing of scientific and risk information
Business Challenges
◦ Business justification
◦ Management Support
◦ Budgeting silos across business units
Implementation Challenges
◦ Collaboration between functions
◦ Experience with new concepts
◦ Workload and resource limitations
6023-09-2015
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61. The development approach should be adapted based
on the complexity and specificity of product and
process.
FDA encourages applicants are encouraged to contact
regulatory authorities regarding questions related to
specific information to be included in their
application.
Using the Quality by Design (QbD) approach does not
change regional regulatory requirements but can
provide opportunities for more flexible approaches to
meet them. In all cases, good manufacturing practice
(GMP) compliance is expected.
6123-09-2015
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62. Quality Target Product Profile (QTPP)
Determine “potential” critical quality attributes (CQAs)
Link raw material attributes and process parameters to
CQAs and perform risk assessment
Develop a design space (optional and not required)
Design and implement a control strategy
Manage product lifecycle, including continual
improvement
CQA’s
Product Profile
Risk Assessments
Design Space
Control Strategy
Continual
Improvement
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63. This presentation is compiled from freely
available resource like the website of FDA, EMA
and ICH .
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
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