This summarizes the ICH Q11 and covers the major topics of this guideline. For brief overview please go through the actual guideline present on ICH website.
This document provides guidelines for assessing and controlling elemental impurities in drug products. It establishes permitted daily exposure (PDE) levels for various elemental impurities based on toxicity data. It then describes a risk-based approach to control elemental impurities in drug products by identifying potential sources, evaluating risks, and defining necessary controls. The guidelines apply to new drug products and do not expect existing products to tighten limits unless exceeding PDEs.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
The ICH Q1A guideline provides recommendations for conducting stability studies on drug substances and drug products to establish retest and shelf-life periods. Key points include:
- Stability studies should be conducted on 3 primary batches under long-term, intermediate, and accelerated storage conditions specified in the guideline.
- Testing frequency is typically every 3 months for the first year of long-term studies and specifications cover physical, chemical, biological, and microbiological attributes.
- The purpose is to evaluate how quality varies over time under influence of factors like temperature and humidity and provide evidence to support recommended storage conditions.
Best techniques to control Genotoxities and impact of ICH M7 guidelineBhaswat Chakraborty
This document discusses best techniques to control genotoxic impurities according to the ICH M7 guideline. It covers the scope and principles of ICH M7, including risk assessment of potential genotoxic impurities in drug substances and products. It also discusses classification of impurities, acceptable intake levels, control options, and retrospective application of ICH M7 to marketed products. The goal is to limit risk from genotoxic impurities to virtually safe levels through appropriate testing, control, and documentation strategies.
This document provides guidance on specifications for new drug substances and products. It aims to establish a single set of global specifications. Specifications include a list of tests, procedures, and acceptance criteria to ensure quality. Tests are used to characterize the drug substance and product properties such as identity, purity, strength, and stability. The guidance addresses setting specifications and acceptance criteria based on development data and justification. It provides recommendations for common tests like residual solvents, water content, polymorphism and enantiomers. The document aims to harmonize specifications accepted by major regulatory authorities.
This document provides guidelines for assessing and controlling elemental impurities in drug products. It establishes permitted daily exposure (PDE) levels for various elemental impurities based on toxicity data. It then describes a risk-based approach to control elemental impurities in drug products by identifying potential sources, evaluating risks, and defining necessary controls. The guidelines apply to new drug products and do not expect existing products to tighten limits unless exceeding PDEs.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
The ICH Q1A guideline provides recommendations for conducting stability studies on drug substances and drug products to establish retest and shelf-life periods. Key points include:
- Stability studies should be conducted on 3 primary batches under long-term, intermediate, and accelerated storage conditions specified in the guideline.
- Testing frequency is typically every 3 months for the first year of long-term studies and specifications cover physical, chemical, biological, and microbiological attributes.
- The purpose is to evaluate how quality varies over time under influence of factors like temperature and humidity and provide evidence to support recommended storage conditions.
Best techniques to control Genotoxities and impact of ICH M7 guidelineBhaswat Chakraborty
This document discusses best techniques to control genotoxic impurities according to the ICH M7 guideline. It covers the scope and principles of ICH M7, including risk assessment of potential genotoxic impurities in drug substances and products. It also discusses classification of impurities, acceptable intake levels, control options, and retrospective application of ICH M7 to marketed products. The goal is to limit risk from genotoxic impurities to virtually safe levels through appropriate testing, control, and documentation strategies.
This document provides guidance on specifications for new drug substances and products. It aims to establish a single set of global specifications. Specifications include a list of tests, procedures, and acceptance criteria to ensure quality. Tests are used to characterize the drug substance and product properties such as identity, purity, strength, and stability. The guidance addresses setting specifications and acceptance criteria based on development data and justification. It provides recommendations for common tests like residual solvents, water content, polymorphism and enantiomers. The document aims to harmonize specifications accepted by major regulatory authorities.
The document discusses guidelines for controlling elemental impurities in pharmaceutical products according to ICH Q3D. It provides information on:
- Common sources of elemental impurities in drug products
- Classification of elements into categories based on their toxicity and likelihood of occurrence
- Methods for establishing permitted daily exposures (PDEs) for elements
- A risk-based approach to assessing and controlling elemental impurities that includes identifying potential sources, evaluating levels compared to PDEs, and documenting control plans
- Options for converting PDEs into concentration limits in drug products or components
The guidelines aim to replace qualitative heavy metal limits with quantitative control of specific elemental impurities shown to have no therapeutic benefit. Manufacturers must
The document provides guidelines for specifications of new drug substances and products. It discusses setting specifications based on development data and stability studies. Universal tests for drug substances include identification, assay, impurities. For products, additional tests depend on dosage form and may include dissolution, uniformity, sterility. The guidelines provide concepts for justifying specifications and periodic testing. They apply principles for biotech products, addressing characterization, analytical validation, process controls, and linking specifications to manufacturing and clinical data.
Impurities ICH Q3 Guidelines Au Vivek JainVivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
The document summarizes the ICH Q2 R1 guideline on the validation of analytical procedures. It discusses the objective of validation, which is to demonstrate that an analytical procedure is suitable for its intended purpose. It describes the types of analytical procedures that should be validated, including identification tests, quantitative impurity tests, limit tests for impurities, and assay procedures. It then goes into detail describing the validation parameters that should be tested, including specificity, accuracy, precision, detection limit, quantitation limit, linearity, range, robustness, and system suitability. The document provides information on how to validate both compendial and non-compendial analytical procedures, as well as the concept of verification for compendial methods
The document provides guidance on good manufacturing practices (GMP) for manufacturing active pharmaceutical ingredients (APIs) according to ICH Q7 guidelines. It discusses quality management, facilities and equipment requirements, documentation, materials management, production controls, validation, and specific guidance for APIs made by cell culture/fermentation. The objective is to help ensure APIs meet quality and purity standards. It provides recommendations but does not replace regulatory requirements.
This document provides an overview of current good manufacturing practice (cGMP) guidelines for active pharmaceutical ingredients (APIs) according to the US Food and Drug Administration (FDA). It discusses cGMP requirements for personnel responsibilities and training, facility design and maintenance, process utilities, containment practices, documentation and record keeping, and control of contamination during API manufacturing. The document is intended to provide guidance on complying with cGMP standards to ensure the quality of APIs.
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
Impurities in drug substance (ich q3 a)Bhanu Chava
This document discusses guidelines for classifying, reporting, controlling, and qualifying impurities in new drug substances. It defines types of impurities and provides thresholds for reporting, identifying, and qualifying impurities. The key points are:
- Impurities are classified as organic, inorganic, or residual solvents. Organic impurities can arise from starting materials, byproducts, or degradation.
- Identification thresholds determine which impurities must be identified and qualified. Impurities above reporting thresholds must be reported.
- Specifications list individual specified impurities and general limits for unspecified impurities.
- Qualification involves evaluating safety data for impurities at specified levels. Impurities may need further study if usual qualification thresholds
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
ICH Guidelines for Stability Testing of Drug Substance and Drug Productsonalgupta200
The document discusses the objectives, scope, rationale and advantages of stability testing. It aims to provide evidence on how the quality of a drug substance or product varies over time under different environmental conditions, and to establish storage conditions, re-test periods and shelf lives. Stability testing is conducted on both drug substances and drug products to ensure safety, efficacy and quality are maintained throughout the proposed shelf life. The International Conference on Harmonisation guidelines provide recommendations for conducting stability studies.
The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.
To recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
The guideline applies to all dosage forms and routes of administration.
This guidelines does not address all possible solvents, only those identified in drugs at that time, neither address solvents intentionally used as excipients nor solvates.
The maximum acceptable intake per day of residual solvent in pharmaceutical products is defined as “permitted daily exposure” (PDE)
Previously, another terms were used like “Tolerable daily intake” (TDI) & “Acceptable daily intake” (ADI) by different organization & authorities, but now usually this new term “PDE” is used
The document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
This document discusses ICH guidelines related to impurities in new drug substances and products. It defines key terms like impurity, identified impurity, and potential impurity. It categorizes impurities as organic, inorganic, or residual solvents. The guidelines provide thresholds for identification, qualification, and reporting of impurities. They also classify residual solvents and elemental impurities based on their toxicity, providing permissible daily exposure limits. The guidelines aim to establish qualification of impurities at levels present in early clinical trials and provide a risk-based approach to control impurities.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
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.
The document discusses Quality by Design (QbD) in the pharmaceutical industry. It defines QbD and outlines its key benefits, including higher product quality assurance, cost savings, and regulatory flexibility. The main elements of QbD are described as identifying target quality profiles, critical quality attributes, risk assessment, linking attributes and parameters to quality, defining a design space and control strategy. QbD facilitates innovation and continuous improvement across a product's lifecycle.
The document discusses guidelines for controlling elemental impurities in pharmaceutical products according to ICH Q3D. It provides information on:
- Common sources of elemental impurities in drug products
- Classification of elements into categories based on their toxicity and likelihood of occurrence
- Methods for establishing permitted daily exposures (PDEs) for elements
- A risk-based approach to assessing and controlling elemental impurities that includes identifying potential sources, evaluating levels compared to PDEs, and documenting control plans
- Options for converting PDEs into concentration limits in drug products or components
The guidelines aim to replace qualitative heavy metal limits with quantitative control of specific elemental impurities shown to have no therapeutic benefit. Manufacturers must
The document provides guidelines for specifications of new drug substances and products. It discusses setting specifications based on development data and stability studies. Universal tests for drug substances include identification, assay, impurities. For products, additional tests depend on dosage form and may include dissolution, uniformity, sterility. The guidelines provide concepts for justifying specifications and periodic testing. They apply principles for biotech products, addressing characterization, analytical validation, process controls, and linking specifications to manufacturing and clinical data.
Impurities ICH Q3 Guidelines Au Vivek JainVivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
The document summarizes the ICH Q2 R1 guideline on the validation of analytical procedures. It discusses the objective of validation, which is to demonstrate that an analytical procedure is suitable for its intended purpose. It describes the types of analytical procedures that should be validated, including identification tests, quantitative impurity tests, limit tests for impurities, and assay procedures. It then goes into detail describing the validation parameters that should be tested, including specificity, accuracy, precision, detection limit, quantitation limit, linearity, range, robustness, and system suitability. The document provides information on how to validate both compendial and non-compendial analytical procedures, as well as the concept of verification for compendial methods
The document provides guidance on good manufacturing practices (GMP) for manufacturing active pharmaceutical ingredients (APIs) according to ICH Q7 guidelines. It discusses quality management, facilities and equipment requirements, documentation, materials management, production controls, validation, and specific guidance for APIs made by cell culture/fermentation. The objective is to help ensure APIs meet quality and purity standards. It provides recommendations but does not replace regulatory requirements.
This document provides an overview of current good manufacturing practice (cGMP) guidelines for active pharmaceutical ingredients (APIs) according to the US Food and Drug Administration (FDA). It discusses cGMP requirements for personnel responsibilities and training, facility design and maintenance, process utilities, containment practices, documentation and record keeping, and control of contamination during API manufacturing. The document is intended to provide guidance on complying with cGMP standards to ensure the quality of APIs.
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
Impurities in drug substance (ich q3 a)Bhanu Chava
This document discusses guidelines for classifying, reporting, controlling, and qualifying impurities in new drug substances. It defines types of impurities and provides thresholds for reporting, identifying, and qualifying impurities. The key points are:
- Impurities are classified as organic, inorganic, or residual solvents. Organic impurities can arise from starting materials, byproducts, or degradation.
- Identification thresholds determine which impurities must be identified and qualified. Impurities above reporting thresholds must be reported.
- Specifications list individual specified impurities and general limits for unspecified impurities.
- Qualification involves evaluating safety data for impurities at specified levels. Impurities may need further study if usual qualification thresholds
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
ICH Guidelines for Stability Testing of Drug Substance and Drug Productsonalgupta200
The document discusses the objectives, scope, rationale and advantages of stability testing. It aims to provide evidence on how the quality of a drug substance or product varies over time under different environmental conditions, and to establish storage conditions, re-test periods and shelf lives. Stability testing is conducted on both drug substances and drug products to ensure safety, efficacy and quality are maintained throughout the proposed shelf life. The International Conference on Harmonisation guidelines provide recommendations for conducting stability studies.
The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.
To recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
The guideline applies to all dosage forms and routes of administration.
This guidelines does not address all possible solvents, only those identified in drugs at that time, neither address solvents intentionally used as excipients nor solvates.
The maximum acceptable intake per day of residual solvent in pharmaceutical products is defined as “permitted daily exposure” (PDE)
Previously, another terms were used like “Tolerable daily intake” (TDI) & “Acceptable daily intake” (ADI) by different organization & authorities, but now usually this new term “PDE” is used
The document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
This document discusses ICH guidelines related to impurities in new drug substances and products. It defines key terms like impurity, identified impurity, and potential impurity. It categorizes impurities as organic, inorganic, or residual solvents. The guidelines provide thresholds for identification, qualification, and reporting of impurities. They also classify residual solvents and elemental impurities based on their toxicity, providing permissible daily exposure limits. The guidelines aim to establish qualification of impurities at levels present in early clinical trials and provide a risk-based approach to control impurities.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
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.
The document discusses Quality by Design (QbD) in the pharmaceutical industry. It defines QbD and outlines its key benefits, including higher product quality assurance, cost savings, and regulatory flexibility. The main elements of QbD are described as identifying target quality profiles, critical quality attributes, risk assessment, linking attributes and parameters to quality, defining a design space and control strategy. QbD facilitates innovation and continuous improvement across a product's lifecycle.
Ich Q8 Pharmaceutical Development( comparison with Q9 and Q10 )DhrutiPatel61
This document provides an overview of pharmaceutical development and quality by design principles. It discusses developing a quality target product profile, identifying critical quality attributes and material/process parameters. The document describes formulation development, manufacturing process development, process controls and continual improvement over a product's lifecycle according to ICH Q8, Q9 and Q10 guidelines. The goal is to build quality into products from the beginning and ensure quality through appropriate controls and risk management approaches.
This presentation introduces Quality by Design (QbD) for pharmaceutical formulation and development. QbD requires understanding how formulation and process variables impact product quality to ensure predefined quality. The benefits of QbD include eliminating batch failures, minimizing deviations, and avoiding regulatory issues. For formulation and development, QbD involves establishing a quality target product profile, identifying critical quality attributes, conducting a risk assessment of drug substance and formulation attributes, developing an initial formulation, using design of experiments for optimization, establishing a control strategy, conducting pilot bioequivalence studies, and scale up with supporting stability studies.
5-Scientific Approach to Validation.pptxAllanThomas30
Validation is a Science and even the most mundane tasks in healthcare environments, like hand washing, must be validated (to ensure correct method and other factors like correct hand wash agent) and also verified - to create an acceptable baseline for post handwash counts.
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.
1. Process analytical technology (PAT) aims to shift pharmaceutical development and manufacturing from testing quality through sampling to building quality into products using continuous monitoring and control strategies.
2. PAT involves establishing quantitative relationships between raw materials, process parameters, and product quality attributes to decrease variability, contamination, and costs while improving quality.
3. The goals of PAT include encouraging innovation through a risk-based regulatory framework that facilitates new manufacturing technologies and ensures consistent application of regulations.
This document provides an overview of quality by design (QbD) in the pharmaceutical industry. It defines QbD as a systematic approach to development that emphasizes product and process understanding based on sound science and quality risk management. The key elements of QbD include identifying critical quality attributes and critical process parameters. QbD aims to design pharmaceutical products and processes to consistently deliver quality and has benefits like reducing batch failures and costs for industry and ensuring consistent quality for consumers.
This document discusses Quality by Design (QbD) and its role in pharmaceutical product development. QbD aims to ensure product quality through scientific development and risk management tools. Key aspects of QbD include defining quality target product profiles, identifying critical quality attributes and critical process parameters, and using this information to establish a design space for manufacturing. The document provides examples of how QbD has been applied in various pharmaceutical development and manufacturing case studies.
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
This document provides an overview of quality by design (QbD) in pharmaceutical development. It discusses the benefits of QbD including eliminating batch failures and ensuring a better designed product. The key aspects of QbD include establishing a quality target product profile, identifying critical quality attributes, performing a risk assessment, defining a design space, describing a control strategy, and enabling continuous improvement through life cycle management. QbD aims to build quality into the product design and manufacturing process through a systematic and scientific approach.
D3. Pharmaceutical Development, Quality by Design.pptxGebremariamWondie
The document discusses key concepts of Quality by Design (QbD) in pharmaceutical product development:
- QbD is a systematic approach that emphasizes product and process understanding through predefined objectives and quality risk management.
- It involves identifying critical quality attributes, understanding how material attributes and process parameters affect them, and using this knowledge to design a control strategy and establish a design space.
- The control strategy ensures consistent product quality by controlling critical process parameters and material attributes based on formulation and process understanding. It can include alternative approaches like real-time release testing.
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.
Review Article: PROCESS ANALYTICAL TECHNOLOGY- Innovative pharmaceutical deve...Vignan University
Process Analytical Technology in pharmaceutical production checks the quality of the raw material attributes
both physically and chemically, that too off-line, in-line or on-line. Process analytical technologies have been
applied to manufacturing processes for decades. PAT is a system for design, analysis, and control of
manufacturing processes, 1
based on continuous monitoring/rapid measurements of critical quality and
performance attributes of raw material, intermediates and products. PAT involves measurement science by
using conventional process sensors such as pressure, temperature and probes. The PAT initiative was initially
intended for traditional pharmaceutical manufacturers, but the FDA.s, PAT guidance now clearly states that it
applies to all manufacturers of human and veterinary drug products. PAT involves shift from testing the quality
to building quality into products by testing at several intermediate steps. It specifically requires that
quantifiable, causal, and predictive relationships be established among the raw materials. There by decreasing
the chances of contamination and cross contamination. It also saves a huge amount of time and money required
for sampling and analysis of the products. Overall PAT paves a way for producing a quality product thus
satisfying the customer needs and creating a good brand image for the organization. PAT that will encourage
the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and
quality assurance as well as novel analyzer technologies.
Quality-by-design(QbD) in pharmaceutical developmentSteffi Thomas
This document discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science. The key aspects of QbD include defining critical quality attributes, establishing a design space of input variables and process parameters to ensure quality, and implementing a control strategy. The goals of QbD are to ensure a predefined quality and quality with effective control through understanding how formulation and manufacturing variables influence product quality.
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 demonstrating that an analytical procedure is suitable for its intended use. It was first proposed in the 1970s by FDA officials to improve pharmaceutical quality. Validation activities focus on manufacturing processes and ensure quality is built into every step. The goal of validation is to demonstrate that a process will consistently produce the expected results. It includes qualification of equipment and training of personnel. The entire production process and individual objects within it undergo validation. Validation helps ensure accurate measurements, adherence to quality standards, and compliance with regulations. It is important for process optimization, reduced costs and failures, improved efficiency, and meeting requirements for product approval and introduction. A validation master plan provides an overview of all validation activities and establishes performance standards.
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.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
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
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
1. ICH Q11 DEVELOPMENT AND
MANUFACTURE OF DRUG
SUBSTANCES (SUMMARY)
Dr. Dilawar Hussain
Pharm.D, MPhil Scholar
Hamdard University (Faculty of Pharmacy)
2. Introduction, Scope and Target
Harmonization of scientific and technical principles relevant to the
design, development & manufacture of drug substances as part of a total
control strategy designed to ensure product quality & consistency.
Provide guidance on the information to be provided in CTD Sections
3.2.S.2.2 – 3.2.S.2.6
Provide further clarification on principles & concepts described in ICH
guidelines Q6,Q8, Q9 & Q10 as they pertain to the specification,
development and manufacture of drug substance.
To establish a commercial manufacturing process capable of consistently
producing drug substance of the intended quality.
3. Manufacturing Process Development
General principles
Drug substance quality link to drug product
Process development tools
Approaches to development
Drug substance critical quality attributes (CQAs)
Linking material attributes & process parameters to drug substance CQAs
Design space
Submission of information
Overall process development summary
Drug substance CQAs
Manufacturing process history
Manufacturing developmental studies
4. Process Development Tools
Quality Risk Management (as described in ICH Q9)
Assessing quality attributes & manufacturing process parameters.
Increasing assurance of routine achievement of acceptable results.
Risk assessment can be carried out early in the development and shall be
repeated as knowledge & understanding increases on the process.
Knowledge Management (as described in ICH Q10)
Prior knowledge & development studies which include chemical, engineering
principles and applied manufacturing experience.
5. Approaches to Development
Approaches of development vary from company to company & product to product.
Traditional Approach:
Identifying potential CQAs having impact on product quality.
Defining appropriate manufacturing process.
Defining a control strategy to ensure process performance & quality.
Enhanced Approach:
Prior knowledge, experimentation and risk assessment.
Determining linkage between material attributes & process parameters to CQAs.
Using enhanced approach in combination with Quality Risk Management to
establish appropriate control strategy.
Traditional & Enhanced approaches are not mutually exclusive.
6. Drug substance Critical Quality Attributes (CQAs)
CQA is a physical / chemical / biological / microbiological property that should be
within an acceptance criteria to ensure the desired product quality.
CQAs are used to guide process development.
CQAs can be modified as the knowledge & process understanding increases.
CQAs include the properties that can affect identity, purity, biological activity and
stability.
Impurities are important aspect of drug substance CQAs due to their potential
impact on drug product safety.
7. Example: Linking Material Attributes and Process
Parameters to Drug Substance CQAs - Chemical Entity
Process design :
Constant concentration of
intermediate F
Constant temperature during reflux
Hydrolysis impurity NMT 0.30%
Possible source of water during
reflux: Water content of
intermediate E
8. Based on risk assessment, parameters affecting hydrolysis :
Time of reflux &
Water content of intermediate E
The reaction was expected to follow second-order kinetics according to the
equation below:
Where F refers to the concentration of intermediate F
9. Graphical presentation
for linking the
extent of hydrolysis to
reflux time &
water content of
intermediate E :
10. Control strategy by Traditional approach :
Dry intermediate E to a maximum water content of 1.0%
Target -reflux time to 1.5 hours & maximum of 4 hours
Control strategy by Enhanced approach :
2nd order rate equation can be integrated (Chemical Reaction Engineering,
Levenspiel 2nd Edition, 1972)
11. Solving this equation for time (t) gives maximum allowable reflux time for any
combination of water
content & target level for hydrolysis impurity (Initial concentration of
intermediate F in reflux mixture will be essentially constant
12. Description of manufacturing process
and process controls
Manufacturing process should be provided as follows,
Process flow diagram,
Sequential procedural narrative,
In-process controls to be indicated in the process description,
Scaling factors, if the process is scale dependant,
Should include design space (if any).
13. Selection of starting materials and
source materials
General principles
Selection of starting materials for synthetic drug substances
Selection of starting materials for semi-synthetic drug substances
Selection of source materials for Biotechnological / Biological products
Submission of information
Justification of starting materials selection for synthetic drug substances
Justification of starting materials selection for semi-synthetic drug Substances
Qualification of source materials for Biotechnological / Biological products
14. Control Strategy
Control strategy is a planned set of controls, derived from product and
process understanding, that assures process performance & quality. It include,
Control on material attributes
Controls implicit in the design of manufacturing process
In-process controls
Controls on drug substance
15. Process Validation / Evaluation
Process validation involves the collection and evaluation of data, from the
process design stage throughout production, that establish scientific evidence
that a process is capable of consistently delivering a quality drug substance.
Process should be validated (ICH Q7) before commercial distribution.
Number of batches to be considered for validation depends on
The complexity of process,
Level of process variability,
Amount of experimental data / process knowledge available on specific
process.
For non-sterile drug substances, results of process validation are not normally
included in the dossier.
16. SUBMISSION OF MANUFACTURING
PROCESS DEVELOPMENT & RELATED
INFORMATION IN CTD FORMAT
Quality risk management and process development in 3.2.S.2.6.
Critical Quality Attributes in 3.2.S.2.6 & 3.2.S.3.1, 3.2.S.4.1 & 3.2.S.7 (if relevant).
Design space in 3.2.S.2.2, 3.2.S.2.4, 3.2.S.2.6, 3.2.S.4.5 (wherever the relevant
justification is applicable).
Control strategy in 3.2.S.4.5 and can also be in 3.2.S.2.2, 3.2.S.2.4, 3.2.S.2.6, 3.2.S.4.1.
17. Life Cycle Management
Product & process knowledge should be managed from development through
the commercial life of the product up to discontinuation.
Process performance, control strategy & suitability of design spaces should be
periodically evaluated through out the life cycle and can be done as a part of
Product Quality Review (ICH Q7).
It includes process development, technology transfer, process validation and
change management activities.
Any changes within the design space (if submitted in DMF) does not require any
approval by regional regulatory authorities.
There should be a systematic managing knowledge related to both drug
substance & manufacturing process throughout the life cycle.