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 document summarizes the key regulatory requirements for pharmaceutical facilities with reference to cGMP. It begins with an introduction on the regulatory requirements for constructing pharmaceutical plants, which are divided into GMP requirements and factory act rules. It then discusses additional regulations related to pollution, hazardous materials storage, and more. The rest of the document outlines specific cGMP requirements related to areas like surroundings, buildings, water systems, waste disposal, personnel, equipment, raw materials, and more. It provides details on what is required for different departmental areas like storage, production, quality control, and sterile product areas. The document concludes with references.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
Regulatory requirements for api registrationRiyaRYadav
The document discusses regulatory requirements for registering an active pharmaceutical ingredient (API). It explains that API registration requires submitting a dossier containing information about the quality of the API. This includes details on manufacturing, characterization, controls, and stability data. The dossier is submitted to health authorities for marketing authorization. It also describes drug master files (DMFs), which provide confidential API information to regulators, and notes their use in the US and EU registration processes. DMFs can reference other DMFs. The document outlines the organization and sections of electronic common technical documents (eCTDs) used to submit API information digitally.
Regulatory requirements for API and BiologicsSimranDhiman12
The document discusses regulatory requirements for active pharmaceutical ingredients (APIs) and biologics. It provides an overview of regulatory guidelines for APIs, including requirements for registration of APIs with agencies like the FDA. It also describes regulatory filings like Drug Master Files (DMFs) that are submitted to provide confidential manufacturing information to support applications. Requirements for biologics are also briefly covered, noting they are complex molecules produced through biotechnology.
Pharmaceutical development report (pdr)Atul Bhombe
The document discusses the key sections and guidelines for an effective Pharmaceutical Development Report (PDR) as outlined in ICH Q8 and Q8(R1). The six critical sections of a PDR are: 1) active and inactive ingredients, 2) formulation development and properties, 3) manufacturing process development, 4) container closure system, 5) microbiological attributes, and 6) compatibility with diluents. The PDR provides a comprehensive understanding of the product and manufacturing process for regulatory review and should be updated throughout the product lifecycle.
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
Technology transfer from R & D to production in pharmaceutical industrySagar Dhadwad
The document discusses technology transfer in the pharmaceutical industry. It defines technology transfer as the process of transferring manufacturing knowledge from research and development sites to production sites. The key steps in the technology transfer process are developing the technology in R&D, pilot plant studies, transferring technology from R&D to production, optimization and production, documentation, and approval. Successful technology transfer requires effective communication and teamwork between the sending and receiving sites.
This document summarizes the key regulatory requirements for pharmaceutical facilities with reference to cGMP. It begins with an introduction on the regulatory requirements for constructing pharmaceutical plants, which are divided into GMP requirements and factory act rules. It then discusses additional regulations related to pollution, hazardous materials storage, and more. The rest of the document outlines specific cGMP requirements related to areas like surroundings, buildings, water systems, waste disposal, personnel, equipment, raw materials, and more. It provides details on what is required for different departmental areas like storage, production, quality control, and sterile product areas. The document concludes with references.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
Regulatory requirements for api registrationRiyaRYadav
The document discusses regulatory requirements for registering an active pharmaceutical ingredient (API). It explains that API registration requires submitting a dossier containing information about the quality of the API. This includes details on manufacturing, characterization, controls, and stability data. The dossier is submitted to health authorities for marketing authorization. It also describes drug master files (DMFs), which provide confidential API information to regulators, and notes their use in the US and EU registration processes. DMFs can reference other DMFs. The document outlines the organization and sections of electronic common technical documents (eCTDs) used to submit API information digitally.
Regulatory requirements for API and BiologicsSimranDhiman12
The document discusses regulatory requirements for active pharmaceutical ingredients (APIs) and biologics. It provides an overview of regulatory guidelines for APIs, including requirements for registration of APIs with agencies like the FDA. It also describes regulatory filings like Drug Master Files (DMFs) that are submitted to provide confidential manufacturing information to support applications. Requirements for biologics are also briefly covered, noting they are complex molecules produced through biotechnology.
Pharmaceutical development report (pdr)Atul Bhombe
The document discusses the key sections and guidelines for an effective Pharmaceutical Development Report (PDR) as outlined in ICH Q8 and Q8(R1). The six critical sections of a PDR are: 1) active and inactive ingredients, 2) formulation development and properties, 3) manufacturing process development, 4) container closure system, 5) microbiological attributes, and 6) compatibility with diluents. The PDR provides a comprehensive understanding of the product and manufacturing process for regulatory review and should be updated throughout the product lifecycle.
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
Technology transfer from R & D to production in pharmaceutical industrySagar Dhadwad
The document discusses technology transfer in the pharmaceutical industry. It defines technology transfer as the process of transferring manufacturing knowledge from research and development sites to production sites. The key steps in the technology transfer process are developing the technology in R&D, pilot plant studies, transferring technology from R&D to production, optimization and production, documentation, and approval. Successful technology transfer requires effective communication and teamwork between the sending and receiving sites.
Regulatory requirements for api registrationSiddu K M
This document discusses regulatory requirements for API registration with the US FDA. It explains that a Drug Master File (DMF), also called an Active Substance Master File (ASMF), is submitted by API manufacturers to the FDA with confidential details about the API. There are different types of DMFs. Type II DMFs cover drug substances, intermediates, and materials used in their preparation. Recently, the FDA has begun assessing Type II API DMFs submitted under GDUFA. DMFs can now be submitted electronically using eCTD format. A DMF includes administrative information and quality modules providing details about the API's manufacture, characterization, controls, and stability. Filing fees for a new API DMF
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.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
This document provides an overview of ICH Q8 guidelines on pharmaceutical development and quality by design. It discusses key concepts like quality target product profiles, critical quality attributes, risk assessment, design space, control strategy, and continual improvement. The guidelines describe applying a science and risk-based approach to developing pharmaceutical products and manufacturing processes to consistently deliver intended performance. A design space is established based on understanding the impact of material attributes and process parameters on critical quality attributes. This knowledge facilitates more flexible regulatory approaches within the approved design space.
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.
Effect of friction, distribution of force, compaction and solubility suraj se...Suraj Pund
This document discusses the effects of friction, force distribution, compaction, and solubility in pharmaceutical manufacturing. It describes how interparticulate and die wall friction affect tablet production, and how lubricants can reduce friction. It also explains that compaction involves compressing and consolidating powders through applied force, and describes the different phases of elastic and plastic deformation that occur during compaction. Finally, it defines solubility and discusses its importance for drug bioavailability and therapeutic effectiveness since drugs must be soluble to be absorbed.
The document discusses the Quality by Design (QbD) approach to pharmaceutical development according to ICH Q8 Annex. It outlines the key steps in QbD, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and continual improvement. QbD emphasizes developing a systematic understanding of products and processes based on science and risk management to ensure quality.
The document discusses drug product performance evaluation through in vitro dissolution testing. It provides details on factors that influence drug dissolution like drug substance properties, formulation composition, manufacturing process, and dissolution test conditions. The key goals of in vitro drug product testing are to characterize drug potency and release rate from oral dosage forms, provide information for formulation development, and ensure quality, comparability and stability over time. Common tests include disintegration testing and dissolution testing using apparatus specified in pharmacopeias to simulate gastrointestinal conditions. The results of in vitro testing aid product development and assessment of shelf-life and quality.
1. Drug stability testing involves conducting studies under various temperature, humidity and light conditions to determine a drug's shelf life and optimal storage requirements.
2. The ICH Q1A guideline provides the standard process for stability testing new drug substances and products to obtain registration. It defines testing stages, storage conditions and frequencies to evaluate how quality varies over time.
3. Stability testing helps establish expiration dates and provides evidence for appropriate packaging and labeling to ensure drug quality through a product's shelf life.
This document discusses validation of solid dosage forms such as tablets and capsules. It describes the types of process validation including prospective, concurrent, and retrospective validation. Key steps in validation of tablets include validation of raw materials, analytical methods, equipment, manufacturing processes, and testing of tablets. Parameters that must be validated for tablet manufacturing include mixing, granulation, drying, milling, lubrication, compression, and coating. Validation of capsules also involves validating the shell and contents along with encapsulation processes and testing. Process validation helps ensure quality and consistency of pharmaceutical products.
The document discusses the selection criteria for container closure systems for pharmaceutical products. There are four main criteria: 1) Protection - the container closure must protect the drug from factors like light, oxygen, and moisture that could degrade it. 2) Compatibility - the container and drug must not interact in ways that could affect drug stability or safety. 3) Safety - the materials used cannot leach harmful substances that the patient could be exposed to. 4) Performance - the container closure must function properly to deliver the drug as intended and support compliance. Compatibility testing, extraction studies, and functionality tests help evaluate different container closure systems.
The document discusses the Common Technical Document (CTD) format, which is used for new drug applications submitted to regulatory agencies in Europe, Japan, and the United States. The CTD format aims to increase harmonization across regions. It is organized into five modules covering administrative information, summaries, quality information, nonclinical study reports, and clinical study reports. An electronic version of the CTD (eCTD) uses XML formatting to improve the submission and review process. The eCTD allows for increased accuracy, reduced costs and time to market, and easier navigation compared to the paper CTD format.
The document provides information on the design and operation of a pharmaceutical pilot plant. It discusses why pilot plants are used, including to evaluate processes at a larger scale and identify critical issues. The summary describes the key objectives of a pilot plant as producing stable dosage forms on a small scale, reviewing equipment, and providing manufacturing guidelines. It also touches on using the pilot plant to design for tablet and capsule production specifically.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
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.
This document discusses ICH guidelines for stability testing and protocols. It provides an overview of the ICH partners that develop guidelines and describes some of the key ICH guidelines related to quality, safety, and efficacy. It then focuses on ICH guideline Q1 which provides recommendations for stability testing of new active pharmaceutical ingredients and finished pharmaceutical products, including stress testing, selection of batches, storage conditions, and photo stability testing. The document also discusses bracketing and matrixing designs for stability testing and outlines what should be included in a stability protocol and report.
CONCEPT & TYPE OF VALIDATION OF GOVERNMENT REGULATIONArul Packiadhas
This document discusses the concept and types of validation of government regulation for pharmaceutical processes. It defines validation and describes the main types, including analytical method validation, equipment validation, cleaning validation, and process validation. For each type, key aspects and considerations are outlined. The history and regulatory basis for process validation are also summarized.
Documentation in pharmaceutical industry, by dr. umesh kumar sharma and anu m...Dr. UMESH KUMAR SHARMA
This document discusses various types of documentation required in the pharmaceutical industry. It begins by explaining that documentation provides necessary details to reduce mistakes and batch variations. There are three main types of documents - commitment documents between industry and regulators, directive documents between management and employees, and record documents between employees and their work. Key documents discussed include master formula records, drug master files, distribution records, and generic drug development requirements. The importance of documentation for regulatory compliance and quality assurance is emphasized.
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.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
Regulatory requirements for api registrationSiddu K M
This document discusses regulatory requirements for API registration with the US FDA. It explains that a Drug Master File (DMF), also called an Active Substance Master File (ASMF), is submitted by API manufacturers to the FDA with confidential details about the API. There are different types of DMFs. Type II DMFs cover drug substances, intermediates, and materials used in their preparation. Recently, the FDA has begun assessing Type II API DMFs submitted under GDUFA. DMFs can now be submitted electronically using eCTD format. A DMF includes administrative information and quality modules providing details about the API's manufacture, characterization, controls, and stability. Filing fees for a new API DMF
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.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
This document provides an overview of ICH Q8 guidelines on pharmaceutical development and quality by design. It discusses key concepts like quality target product profiles, critical quality attributes, risk assessment, design space, control strategy, and continual improvement. The guidelines describe applying a science and risk-based approach to developing pharmaceutical products and manufacturing processes to consistently deliver intended performance. A design space is established based on understanding the impact of material attributes and process parameters on critical quality attributes. This knowledge facilitates more flexible regulatory approaches within the approved design space.
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.
Effect of friction, distribution of force, compaction and solubility suraj se...Suraj Pund
This document discusses the effects of friction, force distribution, compaction, and solubility in pharmaceutical manufacturing. It describes how interparticulate and die wall friction affect tablet production, and how lubricants can reduce friction. It also explains that compaction involves compressing and consolidating powders through applied force, and describes the different phases of elastic and plastic deformation that occur during compaction. Finally, it defines solubility and discusses its importance for drug bioavailability and therapeutic effectiveness since drugs must be soluble to be absorbed.
The document discusses the Quality by Design (QbD) approach to pharmaceutical development according to ICH Q8 Annex. It outlines the key steps in QbD, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and continual improvement. QbD emphasizes developing a systematic understanding of products and processes based on science and risk management to ensure quality.
The document discusses drug product performance evaluation through in vitro dissolution testing. It provides details on factors that influence drug dissolution like drug substance properties, formulation composition, manufacturing process, and dissolution test conditions. The key goals of in vitro drug product testing are to characterize drug potency and release rate from oral dosage forms, provide information for formulation development, and ensure quality, comparability and stability over time. Common tests include disintegration testing and dissolution testing using apparatus specified in pharmacopeias to simulate gastrointestinal conditions. The results of in vitro testing aid product development and assessment of shelf-life and quality.
1. Drug stability testing involves conducting studies under various temperature, humidity and light conditions to determine a drug's shelf life and optimal storage requirements.
2. The ICH Q1A guideline provides the standard process for stability testing new drug substances and products to obtain registration. It defines testing stages, storage conditions and frequencies to evaluate how quality varies over time.
3. Stability testing helps establish expiration dates and provides evidence for appropriate packaging and labeling to ensure drug quality through a product's shelf life.
This document discusses validation of solid dosage forms such as tablets and capsules. It describes the types of process validation including prospective, concurrent, and retrospective validation. Key steps in validation of tablets include validation of raw materials, analytical methods, equipment, manufacturing processes, and testing of tablets. Parameters that must be validated for tablet manufacturing include mixing, granulation, drying, milling, lubrication, compression, and coating. Validation of capsules also involves validating the shell and contents along with encapsulation processes and testing. Process validation helps ensure quality and consistency of pharmaceutical products.
The document discusses the selection criteria for container closure systems for pharmaceutical products. There are four main criteria: 1) Protection - the container closure must protect the drug from factors like light, oxygen, and moisture that could degrade it. 2) Compatibility - the container and drug must not interact in ways that could affect drug stability or safety. 3) Safety - the materials used cannot leach harmful substances that the patient could be exposed to. 4) Performance - the container closure must function properly to deliver the drug as intended and support compliance. Compatibility testing, extraction studies, and functionality tests help evaluate different container closure systems.
The document discusses the Common Technical Document (CTD) format, which is used for new drug applications submitted to regulatory agencies in Europe, Japan, and the United States. The CTD format aims to increase harmonization across regions. It is organized into five modules covering administrative information, summaries, quality information, nonclinical study reports, and clinical study reports. An electronic version of the CTD (eCTD) uses XML formatting to improve the submission and review process. The eCTD allows for increased accuracy, reduced costs and time to market, and easier navigation compared to the paper CTD format.
The document provides information on the design and operation of a pharmaceutical pilot plant. It discusses why pilot plants are used, including to evaluate processes at a larger scale and identify critical issues. The summary describes the key objectives of a pilot plant as producing stable dosage forms on a small scale, reviewing equipment, and providing manufacturing guidelines. It also touches on using the pilot plant to design for tablet and capsule production specifically.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
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.
This document discusses ICH guidelines for stability testing and protocols. It provides an overview of the ICH partners that develop guidelines and describes some of the key ICH guidelines related to quality, safety, and efficacy. It then focuses on ICH guideline Q1 which provides recommendations for stability testing of new active pharmaceutical ingredients and finished pharmaceutical products, including stress testing, selection of batches, storage conditions, and photo stability testing. The document also discusses bracketing and matrixing designs for stability testing and outlines what should be included in a stability protocol and report.
CONCEPT & TYPE OF VALIDATION OF GOVERNMENT REGULATIONArul Packiadhas
This document discusses the concept and types of validation of government regulation for pharmaceutical processes. It defines validation and describes the main types, including analytical method validation, equipment validation, cleaning validation, and process validation. For each type, key aspects and considerations are outlined. The history and regulatory basis for process validation are also summarized.
Documentation in pharmaceutical industry, by dr. umesh kumar sharma and anu m...Dr. UMESH KUMAR SHARMA
This document discusses various types of documentation required in the pharmaceutical industry. It begins by explaining that documentation provides necessary details to reduce mistakes and batch variations. There are three main types of documents - commitment documents between industry and regulators, directive documents between management and employees, and record documents between employees and their work. Key documents discussed include master formula records, drug master files, distribution records, and generic drug development requirements. The importance of documentation for regulatory compliance and quality assurance is emphasized.
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.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
DEFINITION,PRINCIPLE, OBJECTIVES, ELEMENTS AND TOOLS OF QUALITY BY DESIGN (Qb...Durgadevi Ganesan
Quality by Design is a concept first outlined by Joseph M. Juran in various publications. He supposed that quality could be planned. The concept of QBD was mention in ICH Q8 guidelines, which states that, “To identify quality can not be tested in products, i.e. Quality should be built in to product by design.”
What is Quality by Design (QbD)?
Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Why QbD?
Principle of QbD
Objectives of QbD
ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN:
- Quality Target Product Profile
- Critical Quality Attributes
- Product Design and Understanding
- Process Design and Understanding
- Process Design and Understanding
- Design space
- Control Strategy
- Continual Improvement
DESIGN TOOLS
- Prior Knowledge
- Risk Assessment
- Mechanistic Model, Design of Experiments, and Data Analysis
- Process Analytical Technology
Quality by Design and Process Analytical TechnologyMANIKANDAN V
This document discusses Quality by Design (QbD) and Process Analytical Technology (PAT) as applied to the pharmaceutical industry. It defines key QbD concepts like Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters, and design space. It explains how QbD involves systematic development through risk assessment and control strategies to consistently deliver quality products. PAT is described as using real-time measurements and process monitoring to ensure quality and facilitate continuous improvement. The roles of QbD and PAT in drug development and manufacturing are also summarized.
Quality by Design (QbD) is a systematic, holistic, and proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding through sound science and quality risk management. It involves defining a Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQAs), then linking raw material attributes and manufacturing process parameters to the CQAs. This allows designing a control strategy and establishing a design space to ensure the output meets the QTPP. QbD focuses on continuous improvement throughout the product's lifecycle.
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )DhrutiPatel61
This document provides an overview of pharmaceutical development and quality by design principles. It discusses developing a quality target product profile, identifying critical quality attributes and material/process parameters. The document describes formulation development, manufacturing process development, process controls and continual improvement over a product's lifecycle according to ICH Q8, Q9 and Q10 guidelines. The goal is to build quality into products from the beginning and ensure quality through appropriate controls and risk management approaches.
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 discusses key concepts of Pharmaceutical Quality by Design (QbD), including defining a quality target product profile, identifying critical quality attributes, understanding the product and manufacturing process through tools like risk assessment and design of experiments, establishing a design space and control strategy, and enabling continual improvement. The goals of QbD are to enhance robustness and control of the manufacturing process to reliably deliver the desired product quality and performance.
The document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses key QbD concepts like defining a quality target product profile, identifying critical quality attributes and critical material attributes, designing quality into the product through development strategies like design of experiments, and establishing a design space and control strategy. The document outlines the important steps and aspects of a QbD-based pharmaceutical development process from formulation to manufacturing. It emphasizes gaining process understanding, building quality into the product, and taking a systematic risk-based approach.
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 is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
The document discusses the concept of Pharmaceutical Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. QbD aims to design quality products and manufacturing processes that consistently deliver intended performance, following ICH guidelines Q8 on pharmaceutical development, Q9 on quality risk management, and Q10 on pharmaceutical quality systems. Implementing QbD provides benefits like eliminating batch failures, minimizing deviations, and ensuring consistent product quality.
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. The key elements of QbD include defining a Target Product Quality Profile, identifying critical quality attributes and critical process parameters, risk assessment, establishing a design space, and developing a control strategy. The objectives of QbD are to identify important product attributes leading to quality, determine attributes that impact product variability, and establish a design space to allow variability in material attributes.
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 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 discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. QbD has been adopted by the FDA and aims to design quality into products and manufacturing processes from the beginning. It provides benefits like reduced batch failures, cost savings, and more efficient regulatory oversight. The key aspects of QbD include defining target quality attributes, identifying critical process parameters, establishing a design space, and implementing a risk-based control strategy.
Quality by design (QbD) is a systematic approach to drug development that emphasizes product and process understanding based on science and risk management. It was introduced by the FDA to modernize chemistry, manufacturing, and control for biologics, pharmaceuticals, and vaccines. QbD has now become mandatory for drug submissions. The key principles of QbD include clear definition of product requirements, use of quality risk management in all development aspects, enhanced product and process understanding, improved specifications and control strategies using modern technologies like process analytical technologies. QbD aims to design high quality products and manufacturing processes to consistently deliver intended performance.
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
This document discusses factorial design in pharmaceutical research. It defines key terms like factors, levels, and effects. Factorial design is used to study the effect of different factors and their interactions on a response. It presents examples of 2^2, 2^3, and 3^2 factorial designs and how to compute main effects and interactions. Data analysis methods like Yates' method and ANOVA are described. The design allows fitting of a polynomial equation to optimize a response based on factor levels. Advantages include efficiency in estimating effects and revealing interactions across factor levels.
This document discusses immunoassays and two common types - radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (ELISA). RIA involves labeling an antigen or antibody with a radioactive material to measure it in a mixture. It is very sensitive but involves radiation hazards. ELISA uses an enzyme-linked antibody or antigen to detect the presence of a substance. It is a plate-based assay that is sensitive, reproducible, and does not use radiation. Both methods are used for applications like disease detection, drug monitoring, and analyzing hormones and metabolites.
HPTLC is an improved version of TLC that provides better resolution and allows for quantitative analysis. It uses plates with finer silica gel particles between 5-7 micrometers compared to 10-25 micrometers for regular TLC. This allows for faster development times of 3-20 minutes for HPTLC versus 30-200 minutes for TLC. HPTLC also has automated instrumentation for precise sample application and development as well as densitometric scanning for quantification. It has various applications in pharmaceutical analysis, clinical analysis, food and environmental testing by providing fingerprints to identify compounds and allowing quantification of biomarkers.
Freedom to Operate (FTO) refers to whether it’s commercially ‘safe’ for you to make or sell your product in the country in which you wish to do so, without infringing existing third-party rights.
A patent is the granting of a property right by a sovereign authority to an inventor. This grant provides the inventor exclusive rights to the patented process, design, or invention for a designated period in exchange for a comprehensive disclosure of the invention.
The Statisticians Role in Pharmaceutical DevelopmentAshwani Dhingra
Statistics plays an important role in drug development. Its use is necessary for planning and analysing trials and using statistics correctly is crucial for the success of drug development programs.
This document discusses strategies and databases for searching patents. It begins by outlining the main purposes of patent searching, including assessing prior art, patent validity, and freedom to operate. It then describes different types of patent searches and searching methods, including using keywords, classification codes, and semantic or chemical structure searches. The document provides details on major free databases like Espacenet, Patentscope, and The Lens, as well as paid databases. It also discusses using patent classification codes from systems like IPC and CPC to refine searches.
Electrophoresis is a laboratory technique used to separate DNA, RNA, or protein molecules based on their size and electrical charge. An electric current is used to move molecules to be separated through a gel. Pores in the gel work like a sieve, allowing smaller molecules to move faster than larger molecules.
High Performance Liquid Chromatography (HPLC) is a separation technique that involves injecting a small volume of liquid sample into a column packed with tiny particles. Individual components of the sample are then transported through the column by a mobile phase and separated based on interactions with the stationary phase. These separated components exit the column and are detected, providing a chromatogram. HPLC uses small particle sizes, high column pressures up to 6000-9000 psi, and flow rates of 1-3 mL/min to achieve fast, efficient, and high resolution separations of both volatile and non-volatile compounds.
Ion-exchange chromatography (IEC) is an important analytical technique used for the separation and determination of ionic compounds, together with ion-partition/interaction and ion-exclusion chromatography. It is based on the ionic interactions between ionic and polar analytes, ions present in the eluent and ionic functional groups fixed to the chromatographic support.
In mass spectrometry, fragmentation is the dissociation of energetically unstable molecular ions formed from passing the molecules in the ionization chamber of a mass spectrometer. The fragments of a molecule cause a unique pattern in the mass spectrum.
Mass spectrometry (MS) is an analytical technique that is used to measure the molecular weight of the compounds. The results are typically presented as a mass spectrum, a plot of intensity as a function of the mass-to-charge ratio.
Hypolipidemic agents, also known as cholesterol-lowering drugs or antihyperlipidemic agents, are a diverse group of pharmaceuticals that are used in the treatment of high levels of fats (lipids), such as cholesterol, in the blood (hyperlipidemia). They are also called lipid-lowering drugs.
UV/Vis spectroscopy is routinely used in analytical chemistry for the quantitative determination of different analytes, such as transition metal ions, highly conjugated organic compounds, and biological macromolecules. Molecules containing bonding and non-bonding electrons undergo electronic transitions and absorb energy in the form of ultraviolet or visible light to excite these electrons to higher anti-bonding molecular orbitals.
A Free 200-Page eBook ~ Brain and Mind Exercise.pptxOH TEIK BIN
(A Free eBook comprising 3 Sets of Presentation of a selection of Puzzles, Brain Teasers and Thinking Problems to exercise both the mind and the Right and Left Brain. To help keep the mind and brain fit and healthy. Good for both the young and old alike.
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How to Manage Reception Report in Odoo 17Celine George
A business may deal with both sales and purchases occasionally. They buy things from vendors and then sell them to their customers. Such dealings can be confusing at times. Because multiple clients may inquire about the same product at the same time, after purchasing those products, customers must be assigned to them. Odoo has a tool called Reception Report that can be used to complete this assignment. By enabling this, a reception report comes automatically after confirming a receipt, from which we can assign products to orders.
Elevate Your Nonprofit's Online Presence_ A Guide to Effective SEO Strategies...TechSoup
Whether you're new to SEO or looking to refine your existing strategies, this webinar will provide you with actionable insights and practical tips to elevate your nonprofit's online presence.
How to Download & Install Module From the Odoo App Store in Odoo 17Celine George
Custom modules offer the flexibility to extend Odoo's capabilities, address unique requirements, and optimize workflows to align seamlessly with your organization's processes. By leveraging custom modules, businesses can unlock greater efficiency, productivity, and innovation, empowering them to stay competitive in today's dynamic market landscape. In this tutorial, we'll guide you step by step on how to easily download and install modules from the Odoo App Store.
Andreas Schleicher presents PISA 2022 Volume III - Creative Thinking - 18 Jun...EduSkills OECD
Andreas Schleicher, Director of Education and Skills at the OECD presents at the launch of PISA 2022 Volume III - Creative Minds, Creative Schools on 18 June 2024.
Gender and Mental Health - Counselling and Family Therapy Applications and In...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
THE SACRIFICE HOW PRO-PALESTINE PROTESTS STUDENTS ARE SACRIFICING TO CHANGE T...indexPub
The recent surge in pro-Palestine student activism has prompted significant responses from universities, ranging from negotiations and divestment commitments to increased transparency about investments in companies supporting the war on Gaza. This activism has led to the cessation of student encampments but also highlighted the substantial sacrifices made by students, including academic disruptions and personal risks. The primary drivers of these protests are poor university administration, lack of transparency, and inadequate communication between officials and students. This study examines the profound emotional, psychological, and professional impacts on students engaged in pro-Palestine protests, focusing on Generation Z's (Gen-Z) activism dynamics. This paper explores the significant sacrifices made by these students and even the professors supporting the pro-Palestine movement, with a focus on recent global movements. Through an in-depth analysis of printed and electronic media, the study examines the impacts of these sacrifices on the academic and personal lives of those involved. The paper highlights examples from various universities, demonstrating student activism's long-term and short-term effects, including disciplinary actions, social backlash, and career implications. The researchers also explore the broader implications of student sacrifices. The findings reveal that these sacrifices are driven by a profound commitment to justice and human rights, and are influenced by the increasing availability of information, peer interactions, and personal convictions. The study also discusses the broader implications of this activism, comparing it to historical precedents and assessing its potential to influence policy and public opinion. The emotional and psychological toll on student activists is significant, but their sense of purpose and community support mitigates some of these challenges. However, the researchers call for acknowledging the broader Impact of these sacrifices on the future global movement of FreePalestine.
5. Quality-by-Design
Can we measure the QUALITY
??? YES !!!!!!!!!!!!
Can we measure
the QUALITY of Medicine???
NO
“You can’t test quality into drug products”
6. Quality-by-Design
Regulations for QUALITY Medicine
1960- FDA- GMP
1987- FDA - Validation
2002- FDA- cGMP
2006- ICH- Q9 (Quality Risk Mangement)
2008- FDA – Quality- by- Design
2008- ICH – Q8 (Pharmaceutical Development)
2011- ICH- Q10 (Pharmaceutical Quality System)
2012- ICH –Q11 (Development of Drug Substance & Others)
2013- US Laws for Quality Generics Medicine
Quality
by
Design
7. Quality-by-Design
Quality by design is -
• a systematic approach to development
• that begins with predefined objectives
• and emphasizes on
- product & process understanding
- process control,
• based on sound science and quality risk
management.
- ICH
8. Quality-by-Design
What is QUALITY MEDICINE ???
Quality
Patient
(or surrogate)
Target Product:
Quality Profile
Requirements,
need or
expectations
“Good pharmaceutical quality represents
an acceptably low risk of failing to achieve
the desired clinical attributes.”
10. Quality-by-Design
Quality-by-Design
Ensure higher level of assurance of product
quality for patient
Improved product and process design & understanding
Monitoring, tracking & trending of product & process.
More efficient regulatory oversight
Efficiency and cost saving for industry
Increase efficiency of manufacturing process
Minimize / eliminate potential compliance actions
12. Quality-by-Design
System Comparison
Traditional vs. QbD
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
Patient
Production
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
Patient
Production
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
Patient
Production
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
Patient
Production
System
Quality
System
To-Be: QbD Pharmaceutical Product Supply System
13. Quality-by-Design
Current Approach QbD Approach
Quality assured by testing and
inspection
Quality built into product & process
by design, based on scientific
understanding
Data intensive submission –
disjointed information without “big
picture”
Knowledge rich submission –
showing product knowledge &
process understanding
Specifications based on batch history Specifications based on product
performance requirements
Focus on reproducibility – often
avoiding or ignoring variation
Focus on robustness – understanding
and controlling variation
15. Quality-by-Design
Design of
Experiments
(DOE)
Model Building
And Evaluation
Process Design & Development:
Initial Scoping
Process Characterization
Process Optimization
Process Robustness
Statistical Tool
Product Design & Development:
Initial Scoping
Product Characterization
Product Optimization
Manufacturing Development
and Continuous Improvement:
Develop Control Systems
Scale-up Prediction
Tracking and trending
Statistical
Process Control
Pharmaceutical Development & Product
Lifecycle
16. Quality-by-Design
Steps for Quality-by-Design
Step 1. Agree on the Target Product Profile
Step 2. Determine the Critical Quality Attributes (CQAs)
Step 3. Link the drug and excipient attributes and the
process parameters to the CQAs
Step 4. Define the Design Space
Step 5. Define the Control Strategy & Prepare QbD registration file
Step 6. Product lifecycle management and continual improvement
17. Quality-by-Design
What are the steps in a
Quality by Design approach?
TARGET
PRODUCT
PROFILE
CRITICAL
QUALITY
ATTRIBUTES
PRODUCT
LIFECYCLE
MNGMNT
LINK
MAs AND PPs
TO CQAs
ESTABLISH
CONTROL
STRATEGY
ESTABLISH
DESIGN
SPACE
18. Quality-by-Design
Target Product Profile (TPP)
What is TPP?
– A set of elements that defines the drug product
– The target or goal set in advance
– A guide to Drug Product development
When to define TPP?
– At the start of development
– Knowledge gained in development may change some elements
To design Fast Dissolving Tablet.
DT- 50 Sec. Friability - <0.6%, Dissolution – 90% in 5 min.
19. Quality-by-Design
TPP for Tablet
Components related to safety, efficacy, identity, purity and potency
Critical and non-critical components, e.g.
– Critical: Assay, content uniformity
– Non-critical: Appearance
Fixed and variable components
– Fixed elements must be present
e.g. Dosage form, strength
– Variable elements may have a range of acceptable values
e.g. Tablet weight, assay
22. Quality-by-Design
Critical Quality Attributes
A critical quality attribute (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.
23. Quality-by-Design
Critical Quality Attributes
CQAs are a subset of the TPP
Include critical parameters that are likely to
change based upon variations in raw materials
and processes.
CQAs are monitored throughout the drug
product development.
CQAs ensure that drug product remains within
safe and effective levels.
31. Quality-by-Design
Design Space
• The material attributes and process
parameters that assure quality.
• The multidimensional combination and
interaction of input variables (e.g. material
attributes) and process parameters that have
been demonstrated to provide assurance
of quality.
34. Quality-by-Design
DT
(s)
Friability
Amt. of Dis- 01
Amt. of Dis- 01
Friability
DT
(s)
Amt. of Dis- 02
Friability
DT
(s)
DT
(s)
Friability
Amt. of Dis- 02
DT
(s)
Friability
Amt. of Dis- 01
Amt. of Dis- 02
DT – 50 Seconds
Friability - 0.6%
38. Quality-by-Design
DoE or FbD
A “holistic, mathematical, statically, computer
systems-based approach to the design,
development, and delivery of the BEST product
under a given set of conditions.”
39. Quality-by-Design
Terms Generally Used in DoE or FbD
Variables
1. Independent Variables: Formulation Variables, Process etc.
2. Dependent Variables: Control Parameters or Evaluation Parameters
Factors: Independent variables which tend to influence the product characteristics.
Level/ Codes: Value assigned to a factor (Low;-1, Medium; 0, High; +1)
Response: Characteristics of the finished product
Effect: The magnitude of the change in response by level of factor
Interaction: Additive response of factor (No Interaction, Synergetic or Antagonistic)
40. Quality-by-Design
Models used for DoE or FbD
Response Surface Factorial Design – 22, 32 Factorial Design
Central Composite Design - 33 Factorial Design
Box-Wilson Design - 33 Factorial Design
Box Benchen Design - 33 Factorial Design
Factorial Factorial Design – 2K Factorial Design
Taguchi Design – Screening Studies
41. Quality-by-Design
Models for DoE or FbD
Factors: 02
Level: 03
Factor Coded Value Actual Value
Low Medium High Low Medium High
Dis- 01 -1 0 +1 1 2 3
Dis-02 -1 0 +1 5 10 15
23 Factorial Design
46. Quality-by-Design
Solution by DoE or FbD
Solutions
Number Dis-01 Dis-02 DT
Friabilit
y
Desirability
1 0.771 0.750 50.0 0.600 1.000 Selected
2 0.744 0.760 50.0 0.600 1.000
3 0.976 0.661 50.0 0.602 0.999
DT – 50 Seconds
Friability - 0.6%
47. Quality-by-Design
Design of experiments (DoE)
– Useful for screening of variables with significant impact on DP CQAs
– Classical approach than OFAT (One Factor At A Time)
– Limited number of experiments gives huge information.
– DoE helps study effects of interaction of multiple factors at a time
– Used in optimization studies, enables creation of “target space”
– “Target space” is proposed by the applicant and subject to regulatory assessment
and approval.
– “Target space” developed at lab or pilot scale can be proposed for commercial scale,
but needs to be verified at production scale for scale dependant parameters.
50. Quality-by-Design
Impact of QbD
Academics: Changes their curriculum
Research: New meaningful solutions
Industry: Changes their Research Methodology
Adopt the QbD Methodology for PD
Regulators: Changes their Laws.
Recent Advances in Pharmaceutical Education & Research