This document provides guidance for Official Medicines Control Laboratories (OMCLs) on implementing measurement uncertainty in compliance testing as required by ISO 17025. It defines key terms and outlines three approaches to estimating uncertainty - using official, marketing authorization, or internally developed methods. It states that for compliance testing, the overall uncertainty can be expressed as the relative standard deviation, as the methods have been validated and limits set based on their precision. Provided quality systems are in place, this overall approach avoids individually quantifying uncertainty components. The guidance aims to assure confidence in OMCL test results for their intended purpose of compliance testing.
The document summarizes the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines. The ICH brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. The quality guidelines cover topics such as stability testing, validation of analytical procedures, impurities, pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practices, pharmaceutical development, quality risk management, and the pharmaceutical quality system.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
This document provides guidance for assessing the comparability of biotechnological products before and after changes to the manufacturing process. It aims to assist manufacturers in collecting relevant technical information to demonstrate that manufacturing changes will not adversely impact quality, safety or efficacy. The guidelines cover analytical techniques, characterization, specifications, stability and other quality, nonclinical and clinical considerations for evaluating comparability. The goal is to ensure the quality, safety and efficacy of products produced by changed processes through evaluating relevant data. A finding of comparability does not require identical quality attributes but highly similar attributes without adverse impacts on safety or efficacy.
ICH ( International Conference on Harmonization) guidelinesApekshaRajguru
The document provides guidance on several ICH guidelines related to quality, safety, efficacy and multidisciplinary topics. It summarizes key ICH guidelines including Q1A on stability testing, Q2 on analytical validation, and Q3A-Q3E on impurities. It also discusses guidelines for nonclinical safety evaluation (S1-S10), clinical safety data management (E2A, E2B, E2C, E2D), and clinical study reports (E3).
This document summarizes the presentation of ICH stability testing guidelines for new drug substances and products. It discusses the objectives, scope, general principles and guidelines for conducting stability testing of drug substances and products. The key aspects covered include selection of batches, container closure systems, specifications, testing frequency and storage conditions for long term, intermediate and accelerated stability studies. The goals of stability testing are to provide evidence of quality changes over time and establish re-test or shelf life periods under various environmental conditions.
This document summarizes the ICH Q2 R1 Guideline on 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 outlines the types of analytical procedures that should be validated, including identification tests, quantitative impurity tests, limit tests for impurities, and assay procedures. It also describes the key validation characteristics that should be tested, such as specificity, accuracy, precision, detection limit, quantitation limit, linearity, range, robustness, and system suitability. The document provides details on these validation parameters and recommends the type of data that should be collected for each parameter. It also discusses related topics like method verification versus validation and re
This document summarizes key concepts related to quality systems including change control, out of specifications, and out of trends. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to existing systems or processes. It describes the process for managing change control including establishing written procedures and evaluating all changes that could impact quality, safety or efficacy. It also discusses out of specifications results as test results that fall outside established acceptance criteria and the procedures for investigating such results, including retesting and root cause analysis. Finally, it defines out of trend results as those that do not follow the expected trend over time and methods for identifying out of trend results.
The document summarizes the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines. The ICH brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. The quality guidelines cover topics such as stability testing, validation of analytical procedures, impurities, pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practices, pharmaceutical development, quality risk management, and the pharmaceutical quality system.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
This document provides guidance for assessing the comparability of biotechnological products before and after changes to the manufacturing process. It aims to assist manufacturers in collecting relevant technical information to demonstrate that manufacturing changes will not adversely impact quality, safety or efficacy. The guidelines cover analytical techniques, characterization, specifications, stability and other quality, nonclinical and clinical considerations for evaluating comparability. The goal is to ensure the quality, safety and efficacy of products produced by changed processes through evaluating relevant data. A finding of comparability does not require identical quality attributes but highly similar attributes without adverse impacts on safety or efficacy.
ICH ( International Conference on Harmonization) guidelinesApekshaRajguru
The document provides guidance on several ICH guidelines related to quality, safety, efficacy and multidisciplinary topics. It summarizes key ICH guidelines including Q1A on stability testing, Q2 on analytical validation, and Q3A-Q3E on impurities. It also discusses guidelines for nonclinical safety evaluation (S1-S10), clinical safety data management (E2A, E2B, E2C, E2D), and clinical study reports (E3).
This document summarizes the presentation of ICH stability testing guidelines for new drug substances and products. It discusses the objectives, scope, general principles and guidelines for conducting stability testing of drug substances and products. The key aspects covered include selection of batches, container closure systems, specifications, testing frequency and storage conditions for long term, intermediate and accelerated stability studies. The goals of stability testing are to provide evidence of quality changes over time and establish re-test or shelf life periods under various environmental conditions.
This document summarizes the ICH Q2 R1 Guideline on 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 outlines the types of analytical procedures that should be validated, including identification tests, quantitative impurity tests, limit tests for impurities, and assay procedures. It also describes the key validation characteristics that should be tested, such as specificity, accuracy, precision, detection limit, quantitation limit, linearity, range, robustness, and system suitability. The document provides details on these validation parameters and recommends the type of data that should be collected for each parameter. It also discusses related topics like method verification versus validation and re
This document summarizes key concepts related to quality systems including change control, out of specifications, and out of trends. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to existing systems or processes. It describes the process for managing change control including establishing written procedures and evaluating all changes that could impact quality, safety or efficacy. It also discusses out of specifications results as test results that fall outside established acceptance criteria and the procedures for investigating such results, including retesting and root cause analysis. Finally, it defines out of trend results as those that do not follow the expected trend over time and methods for identifying out of trend results.
The document provides an overview of ICH guidelines, including:
- ICH was created in 1990 to harmonize technical requirements for drug approval between Europe, Japan, and the US.
- ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics.
- Quality (Q) guidelines cover stability testing, validation, impurities, specifications, and CGMPs.
- The document focuses on Q guidelines for stability, impurities, specifications, and biotechnology products.
The document discusses the International Conference on Harmonization (ICH) and its guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration internationally to ensure safe, effective, and high-quality medicines are developed efficiently. The guidelines are divided into four categories: Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M). Some examples of topics covered include stability testing, impurities, clinical trials, good clinical practice, and electronic standards for regulatory information. The overall goal is to increase international cooperation and reduce redundant testing.
The document outlines procedures for investigating out-of-specification or atypical laboratory test results. It describes conducting a Phase I investigation by the analyst and supervisor to identify obvious errors, and a Phase II investigation when no error is found. Phase II may involve hypothesis testing, retesting using the original sample if possible, or obtaining a new sample. If no assignable cause is identified after manufacturing and laboratory investigations, retesting a portion of the original sample may be considered with approval of a documented test plan.
Is a procedure or set of procedures intended to ensure that a manufactured or performed service adheres to a defined set of quality criteria or meets the requirements of client or customer. QC is similar to, but not identical with, quality assurance (QA)
This document provides an overview of ICH guidelines related to quality (Q series). It describes the composition and objectives of ICH, which aims to harmonize technical requirements for pharmaceutical registration among regulators and industry in the EU, Japan, and US. The key points are that ICH guidelines are divided into four categories, including the Q series which relates to chemical and pharmaceutical quality. The Q series guidelines cover topics like stability testing, analytical validation, impurities, and residual solvents. The goal is to establish common standards for assessing safety, quality and efficacy of medicines.
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
The document discusses the International Conference on Harmonisation (ICH), which brings together regulatory authorities and pharmaceutical experts from Europe, Japan, and the US to discuss product registration. ICH topics are divided into four categories: quality, safety, efficacy, and multidisciplinary. Several multidisciplinary topics are then summarized, including M1 (MedDRA terminology), M2 (electronic standards), M3 (non-clinical safety studies), M4 (common technical document), M7 (mutagenic impurities), M8 (electronic common technical document), M9 (BCS-based biowaivers), and M10 (bioanalytical method validation).
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
The document discusses the International Conference on Harmonization (ICH), an international body that aims to harmonize technical requirements for pharmaceutical product registration. ICH seeks to eliminate unnecessary duplication in drug development studies required by different regions, make more efficient use of resources, and ensure timely access to new medicines for patients. The document outlines ICH's structure and working groups focused on quality, safety, efficacy, and multidisciplinary topics. Guidelines produced by ICH provide a common technical framework to help regulators and industry agree on specifications, test procedures and acceptance criteria for drugs.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The document discusses various ICH guidelines related to quality, safety and efficacy of pharmaceuticals. It provides an overview of ICH (International Conference on Harmonization), its objectives to harmonize technical requirements for drug development and registration. Key guidelines discussed include Q1A-Q1F on stability testing, Q2 on analytical validation, Q3A-Q3D on impurities and Q4-Q5E on quality of biopharmaceutical products. The document describes the structure of ICH including its steering committee, coordinators, secretariat and working groups.
GLP is a formal FDA regulation created in 1978 that provides principles for conducting laboratory studies in a standard, consistent manner. It aims to ensure quality and integrity of data submitted to the FDA. Key GLP principles include requirements for test facility organization, quality assurance programs, facilities, equipment, test systems, standard operating procedures, study conduct, reporting, and record keeping. GLP helps provide reliable results and protects study integrity and data for regulating products like drugs and pesticides.
This document discusses ICH guidelines for stability testing and protocols. It provides an overview of ICH partners and guidelines related to quality, safety, and efficacy. It then focuses on ICH guideline Q1, which provides guidance on stability testing of new active pharmaceutical ingredients and finished pharmaceutical products. Key aspects covered in Q1 include stress testing, selection of batches, storage conditions, container closure systems, and photo stability testing. The document also discusses bracketing and matrixing designs, stability protocols and reports, and requirements for stability results and re-test periods.
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.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
International council for harmonisation (ich) guidelinesMasarrat Khan
The document discusses the International Council for Harmonisation (ICH) guidelines. It provides definitions for ICH as a joint initiative between regulators and industry in the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. The objectives of ICH are outlined as increasing harmonization to ensure safe, effective, and high quality medicines are developed efficiently. The organizational structure and processes of ICH are described, including its steering committee, working groups, and 5 step guideline development process. An overview is provided of the various ICH guidelines categories including quality, safety, efficacy, and multidisciplinary guidelines. Specific stability testing guidelines are also briefly discussed.
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
The document provides an overview of ICH guidelines, including:
- ICH was created in 1990 to harmonize technical requirements for drug approval between Europe, Japan, and the US.
- ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics.
- Quality (Q) guidelines cover stability testing, validation, impurities, specifications, and CGMPs.
- The document focuses on Q guidelines for stability, impurities, specifications, and biotechnology products.
The document discusses the International Conference on Harmonization (ICH) and its guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration internationally to ensure safe, effective, and high-quality medicines are developed efficiently. The guidelines are divided into four categories: Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M). Some examples of topics covered include stability testing, impurities, clinical trials, good clinical practice, and electronic standards for regulatory information. The overall goal is to increase international cooperation and reduce redundant testing.
The document outlines procedures for investigating out-of-specification or atypical laboratory test results. It describes conducting a Phase I investigation by the analyst and supervisor to identify obvious errors, and a Phase II investigation when no error is found. Phase II may involve hypothesis testing, retesting using the original sample if possible, or obtaining a new sample. If no assignable cause is identified after manufacturing and laboratory investigations, retesting a portion of the original sample may be considered with approval of a documented test plan.
Is a procedure or set of procedures intended to ensure that a manufactured or performed service adheres to a defined set of quality criteria or meets the requirements of client or customer. QC is similar to, but not identical with, quality assurance (QA)
This document provides an overview of ICH guidelines related to quality (Q series). It describes the composition and objectives of ICH, which aims to harmonize technical requirements for pharmaceutical registration among regulators and industry in the EU, Japan, and US. The key points are that ICH guidelines are divided into four categories, including the Q series which relates to chemical and pharmaceutical quality. The Q series guidelines cover topics like stability testing, analytical validation, impurities, and residual solvents. The goal is to establish common standards for assessing safety, quality and efficacy of medicines.
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
The document discusses the International Conference on Harmonisation (ICH), which brings together regulatory authorities and pharmaceutical experts from Europe, Japan, and the US to discuss product registration. ICH topics are divided into four categories: quality, safety, efficacy, and multidisciplinary. Several multidisciplinary topics are then summarized, including M1 (MedDRA terminology), M2 (electronic standards), M3 (non-clinical safety studies), M4 (common technical document), M7 (mutagenic impurities), M8 (electronic common technical document), M9 (BCS-based biowaivers), and M10 (bioanalytical method validation).
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
The document discusses the International Conference on Harmonization (ICH), an international body that aims to harmonize technical requirements for pharmaceutical product registration. ICH seeks to eliminate unnecessary duplication in drug development studies required by different regions, make more efficient use of resources, and ensure timely access to new medicines for patients. The document outlines ICH's structure and working groups focused on quality, safety, efficacy, and multidisciplinary topics. Guidelines produced by ICH provide a common technical framework to help regulators and industry agree on specifications, test procedures and acceptance criteria for drugs.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The document discusses various ICH guidelines related to quality, safety and efficacy of pharmaceuticals. It provides an overview of ICH (International Conference on Harmonization), its objectives to harmonize technical requirements for drug development and registration. Key guidelines discussed include Q1A-Q1F on stability testing, Q2 on analytical validation, Q3A-Q3D on impurities and Q4-Q5E on quality of biopharmaceutical products. The document describes the structure of ICH including its steering committee, coordinators, secretariat and working groups.
GLP is a formal FDA regulation created in 1978 that provides principles for conducting laboratory studies in a standard, consistent manner. It aims to ensure quality and integrity of data submitted to the FDA. Key GLP principles include requirements for test facility organization, quality assurance programs, facilities, equipment, test systems, standard operating procedures, study conduct, reporting, and record keeping. GLP helps provide reliable results and protects study integrity and data for regulating products like drugs and pesticides.
This document discusses ICH guidelines for stability testing and protocols. It provides an overview of ICH partners and guidelines related to quality, safety, and efficacy. It then focuses on ICH guideline Q1, which provides guidance on stability testing of new active pharmaceutical ingredients and finished pharmaceutical products. Key aspects covered in Q1 include stress testing, selection of batches, storage conditions, container closure systems, and photo stability testing. The document also discusses bracketing and matrixing designs, stability protocols and reports, and requirements for stability results and re-test periods.
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.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
International council for harmonisation (ich) guidelinesMasarrat Khan
The document discusses the International Council for Harmonisation (ICH) guidelines. It provides definitions for ICH as a joint initiative between regulators and industry in the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. The objectives of ICH are outlined as increasing harmonization to ensure safe, effective, and high quality medicines are developed efficiently. The organizational structure and processes of ICH are described, including its steering committee, working groups, and 5 step guideline development process. An overview is provided of the various ICH guidelines categories including quality, safety, efficacy, and multidisciplinary guidelines. Specific stability testing guidelines are also briefly discussed.
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
This document provides guidance on validation of analytical procedures for pharmaceutical products. It discusses key validation characteristics that should be considered for different types of analytical procedures, including identification tests, assays, and tests for impurities. The document defines important terms and recommends the validation characteristics that should typically be evaluated for each type of analytical procedure. It also provides recommendations on experimental approaches and data to collect in order to validate characteristics like specificity, linearity, range, accuracy, and precision of analytical procedures. The overall goal of validation is to demonstrate that an analytical procedure is suitable for its intended purpose.
This document provides guidance on validating analytical procedures used for drug registration. It discusses four common types of procedures: identification tests, quantitative impurity tests, limit tests for impurities, and assays for active ingredients. Key validation characteristics like accuracy, precision, specificity, range, detection limit, and quantitation limit are defined. The document provides a table summarizing which characteristics are most important to validate for each type of analytical procedure. It notes some circumstances that could require revalidation, like changes to synthesis, product composition, or analytical methods. The overall goal of validation is to demonstrate that analytical procedures are suitable for their intended purpose.
This document provides guidance on validation of analytical procedures for pharmaceutical products. It discusses key validation characteristics that should be considered for different types of analytical procedures, including identification tests, assays, and tests for impurities. The document defines important terms and recommends the validation characteristics that should typically be evaluated for each type of analytical procedure. It also provides recommendations on experimental approaches and data to collect in order to validate characteristics like specificity, linearity, range, accuracy, and precision of analytical procedures. The overall goal of validation is to demonstrate that an analytical procedure is suitable for its intended purpose.
Measuring Instruments Directive (2004/22/EC):
Guide for generating sampling plans
for statistical verification according to
Annex F and F1 of MID 2004/22/EC
Good Laborarory Practices. Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.
ISO 15189 Accreditation Guide - Improving Laboratory Performance Through Qual...Randox
The document discusses ISO 15189 accreditation for medical laboratories. It outlines the importance of quality control and differences between accreditation and certification. Laboratories must implement both internal quality control and external quality assessment to gain ISO 15189 accreditation. This involves using third party controls, clinically relevant quality control material levels, peer group reporting, and participation in external quality assessment schemes. The document provides guidance on quality control considerations and processes needed to achieve and maintain ISO 15189 accreditation.
This document provides guidance for laboratories on quality assurance best practices for analytical chemistry operations. It was prepared jointly by CITAC and EURACHEM, building on previous guidance documents. The guidance aims to help laboratories implement quality systems and address the requirements of the ISO/IEC 17025 standard for testing and calibration laboratories. It focuses on technical quality assurance issues and provides interpretations for chemical testing measurements.
This document provides guidance on common GMP compliance observations that may be found during drug manufacturing inspections and how to properly document these observations in inspection reports. It outlines an integrated six-system model for inspections covering quality, facilities, materials, production, packaging and labeling, and laboratory control systems. Potential observations are grouped into categories like vague procedures, failure to investigate out-of-specification results, lack of standard operating procedures, inadequate cleaning procedures, and lack of in-process monitoring. The goal is to help inspectors comprehensively evaluate GMP compliance and write reports in a clear, consistent and credible manner.
This document provides guidance on validating analytical procedures used for drug registration. It discusses four common types of procedures: identification tests, quantitative impurity tests, impurity limit tests, and active ingredient assays. Key validation characteristics like accuracy, precision, specificity, range and detection/quantitation limits are defined. A table outlines which characteristics are most important to validate for each procedure type. Robustness and revalidation after certain changes are also addressed. The objective is to demonstrate analytical procedures are suitable for their intended use in supporting drug registration applications.
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.
This document provides an overview of ISO 15189:2007, which establishes particular requirements for quality and competence in medical laboratories. It discusses the history and development of the standard, as well as key clauses related to organization, management, quality systems, personnel, equipment, pre-examination procedures, and more. The document is intended to train readers on the requirements of ISO 15189 through paraphrasing and rewording the standard.
Are we using the correct quality goals?Ola Elgaddar
Setting quality goals / specifications is a debatable issue since 1999. I am trying here to show the options and the continuos trials from several professional bodies to reach a consensus in this matter.
This was an oral presentation in the first international conference of the Chemical Pathology Department, Medical Research Institute, Alexandria University - February 2016
This document provides guidelines for validating analytical procedures used in pharmaceutical registration applications. It discusses four common types of analytical procedures: identification tests, impurity tests, limit tests for impurities, and quantitative assays. The guidelines describe key validation characteristics such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and robustness. It provides a table summarizing which characteristics are most important to evaluate for each type of analytical procedure. The document also includes definitions for validation terminology and methodology recommendations for demonstrating various validation characteristics.
This document provides an overview of quality assurance, good manufacturing practices (GMP), and good laboratory practices (GLP). It defines each concept and outlines their key principles and goals. Quality assurance aims to ensure products meet the required quality standards and involves implementing GMP, GLP, and other quality control measures. GMP focuses on establishing processes to minimize risks like contamination during manufacturing. GLP provides a quality system for non-clinical health and safety studies to ensure they are properly planned, performed, documented and reported.
The document discusses strategies for assuring the quality of laboratory results. It covers quality assurance procedures such as quality control, quality assessment, laboratory standardization, and method validation. The key components of quality assurance include quality control, which uses techniques like analysis of reference materials and proficiency testing. Quality assessment involves periodic external evaluation to monitor and improve laboratory performance. Together, effective quality control and assessment help laboratories consistently produce accurate and reliable test results.
Good Laboratory Practice (GLP) guidelines provide standards for laboratory experiments and tests performed to support research, nonclinical studies, and regulatory submissions. The key goals of GLP are to ensure quality, reliability, and integrity of data through adherence to standard operating procedures, trained personnel, appropriate facilities and equipment, records management, and quality control. GLP aims to promote valid and robust research that can be reproduced internationally and supports regulatory review and decision making.
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algorithm.
Advanced control scheme of doubly fed induction generator for wind turbine us...IJECEIAES
This paper describes a speed control device for generating electrical energy on an electricity network based on the doubly fed induction generator (DFIG) used for wind power conversion systems. At first, a double-fed induction generator model was constructed. A control law is formulated to govern the flow of energy between the stator of a DFIG and the energy network using three types of controllers: proportional integral (PI), sliding mode controller (SMC) and second order sliding mode controller (SOSMC). Their different results in terms of power reference tracking, reaction to unexpected speed fluctuations, sensitivity to perturbations, and resilience against machine parameter alterations are compared. MATLAB/Simulink was used to conduct the simulations for the preceding study. Multiple simulations have shown very satisfying results, and the investigations demonstrate the efficacy and power-enhancing capabilities of the suggested control system.
1. OMCL Network of the Council of Europe
QUALITY ASSURANCE DOCUMENT
PA/PH/OMCL (05) 49 DEF CORR
UNCERTAINTY OF MEASUREMENT - PART 1
Full document title and
reference
Uncertainty of Measurement - Part 1
General OMCL Policy for implementation of Measurement
Uncertainty in Compliance Testing
PA/PH/OMCL (05) 49 DEF CORR
Document type Guideline
Legislative basis The present document was also accepted by EA as
recommendation document to be used in the context of Quality
Management System audits of OMCLs
Date of first adoption April 2001
Date of original entry
into force
January 2003
Date of entry into force
of revised document
December 2007
Previous titles/other
references
This document replaces document PA/PH/OMCL (05) 49 DEF
Custodian Organisation The present document was elaborated by OMCL
Network/EDQM of the Council of Europe
Concerned Network GEON
PA/PH/OMCL (05) 49 DEF CORR - OMCL Guideline on Uncertainty of Measurement (for compliance testing)
December 2007 Page 1 of 8
2. GENERAL OMCL POLICY FOR IMPLEMENTATION OF MEASUREMENT
UNCERTAINTY IN COMPLIANCE TESTING
1. INTRODUCTION
This document is intended to give guidance for the interpretation and application of ISO
17025 “General Requirements for the testing and calibration laboratories” [1] and its
pertinence to compliance testing performed in Official Medicines Control Laboratories
(OMCL).
Measurement uncertainty is mentioned in the ISO 17025 standard in several sections, e.g. the
following sections relevant for this document:
5.4.1 Test and calibration methods and method validation – General
5.4.6. Estimation of uncertainty of measurement
5.10.3 Reporting the results – Test reports
The laboratory is to demonstrate that it has adequate knowledge of all aspects of the analytical
procedure relevant to the measurement process, contributing to the overall measurement
uncertainty and that the laboratory has procedures in place to keep these aspects under control
as part of its quality policy. The OMCL should therefore be able, where appropriate, to report
on this issue.
It should be noted that sampling, which may introduce a high degree of uncertainty, is not the
responsibility of an OMCL and therefore the results reported only relate to the specific
sample.
2. OBJECTIVE
Compliance testing of pharmaceutical substances and medicinal products is a statuary
requirement and is performed by OMCLs. The objective of this document is to give the policy
on how to implement the ISO 17025 requirements dealing with the principles of measurement
uncertainty.
3. SCOPE
In the field of pharmaceuticals, the legal framework is enforced by the application of
requirements set by "The Rules Governing Medicinal Products in the European Union",
including "Good Manufacturing Practices", the European Pharmacopoeia and guidelines
adopted by the "International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use". This document is applicable to all activities
related to compliance testing in this field for chemical and biological pharmaceutical
substances and medicinal products for human and veterinary use, within the OMCL Network.
4. DEFINITION
The uncertainty of measurement “characterises the dispersion of the values that would be
reasonably attributed to the measurand” [2].
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3. 5. ESTIMATION OF THE UNCERTAINITY OF MEASUREMENTS
5.1 Introduction
The OMCL activities can be divided into two types:
1. Compliance testing
2. Other testing activities
This document only relates to the compliance testing which comprises testing towards
previously defined specifications. In case of compliance testing, validated or official methods
are used, the uncertainty aspects of which are well known and can be demonstrated to be
under control. Other testing activities are treated in a separate OMCL guidance [3].
5.2 Measurement uncertainties
Both the Eurachem/CITAC Guide [2] and EA guidelines EA 4/16 [12] give two possible
approaches for estimation of measurement uncertainties:
1. Identifying and quantifying each component which contributes to the overall
uncertainty and combining all contributions. This is referred to as a "step-by-step" approach
(combined uncertainty).
2. Data from prior studies originating from defined internal quality control procedures,
from method validation, from collaborative studies or from proficiency tests. These data are
combinations of uncertainty components. This is referred to as the "overall" approach (overall
uncertainty).
5.3 Application to compliance testing (see Appendix 1)
ISO 17025 states that “The laboratory shall use test and/or calibration methods, including
methods for sampling, which meet the needs of the client and which are appropriate for the
tests and/or calibrations it undertakes. Methods published in international, regional or national
standards shall preferably be used”.
In compliance testing analytical procedures can be used from three different origins:
- Official methods (e.g. compendial)
- Methods described in the marketing authorisation
- Internal methods developed in the OMCL.
5.3.1 Official methods (e.g. compendial)
The precision of the method is known and the limits have been set accordingly. The General
Notices of the European Pharmacopoeia [4] states that the limits described are based on data
obtained in normal analytical practice, they take account of normal analytical errors, of
acceptable variations in manufacture and compounding and of deterioration to an extent
considered acceptable. No further tolerances are to be applied to the limits prescribed to
determine whether the article being examined complies with the requirements of the
monograph and “The procedures for the tests and assays published in the individual
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4. monographs have been validated according to the current practice at the time of their
elaboration for the purpose for which they are intended” [5].
5.3.2 Methods described in the marketing authorisation
These methods are fully validated [6] and have been assessed during the licensing procedure
and officially approved by the competent authority.
The precision of the method is known and the limits are set based on validation that has been
assessed and authorised by the competent authority. When the required conditions are met
(i.e. the system suitability or method transfer checks are fulfilled) when applying the method
as prescribed and using appropriate reference substances, the experimental precision is used
to indicate the uncertainty.
5.3.3 Internally developed methods
These methods are validated [7] for the purpose for which they are used and can therefore be
treated as the former cases.
5.4 The overall uncertainty
In all the above approaches the overall uncertainty of the result is expressed by the relative
standard deviation. The methods have been validated and hence the precision of the method is
known which is taken into account when setting the limits of content. Thus, the relative
standard deviation of the result must be below a pre-determined maximal permitted relative
standard deviation that depends on the precision of the method [8]. The data are thus
statistically assessed and the uncertainty of the measurement (estimated by the relative
standard deviation) is taken into account when taking a decision on the acceptability of the
result.
It is recalled that the tests are performed under a properly functioning quality system, which
means that:
1. all balances and volumetric glassware are under regular control
2. official reference substances [9] or in house reference substances are properly
qualified and stored
3. instruments are regularly calibrated
4. equipment is regularly re-qualified
5. laboratory technicians are (re-)qualified
and the uncertainties due to these sources are under control and contribute little to the total
uncertainty of the test result.
It should also be recalled that it is state of the art in pharmaceutical analysis to use pre-defined
system suitability test criteria for the test procedures and analytical acceptance criteria for the
results. These are to be fulfilled to assure good performance [10, 11]. The system suitability
test criteria in many cases are integral part of the method whereas analytical acceptance
criteria of the results are pre-defined by the individual OMCL based on sound statistical
principles.
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5. The application of the above procedure avoids the use of the “step-by-step” approach where
the laboratory calculates the uncertainty by summation of each step or series of steps.
However, such an approach may be usefully employed by an OMCL to identify and estimate
the uncertainty at each stage of the procedure when considered necessary. It is particularly
useful for the investigation of out-of-specification results and for setting limits for
performance tests of measurement apparatus and critical parameters of methods. The
expression of measurement uncertainty is described in the OMCL guideline "Evaluation and
reporting of results” [8];other examples are given in the Eurachem / CITAC Guide [2] and in
the EA guideline on “Expression of uncertainty in quantitative testing” [12].
6. CONCLUSION
The confidence in the result obtained by the OMCLs for compliance testing can be assured by
the ‘overall’ approach for the estimation of the uncertainty, by the application of the system
suitability criteria and by adherence to pre-defined analytical acceptance criteria, provided
that a well-functioning quality system is in place.
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6. 7. GLOSSARY
Compliance testing – Tests performed, using official or validated analytical procedures to
verify that the pharmaceutical substance or medicinal product examined conforms with the
specification limits given in the monograph or in the marketing authorisation.
Measurand – A particular quantity subject to measurement, the parameter to be determined.
System suitability criteria – Performance limits applied to various tests which are designed to
ensure the adequate performance of the analytical procedure. These criteria are to be fulfilled
before proceeding to the analysis of the sample.
Analytical acceptance criteria – Performance limits applied to results obtained from the
analysis performed. These criteria are pre-defined and are dependent on the nature of the
product, the analytical procedure and the limits given in the monograph or in the marketing
authorisation specifications.
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7. 8. REFERENCES
(For all references, the latest version applies)
1. ISO/IEC 17025 “General requirements for the competence of testing and calibration
laboratories”.
2. Quantifying Uncertainty in Analytical Measurements, Eurachem / CITAC Guide CG 4.
3. OMCL Policy on the Establishment and Application of Uncertainty in Analytical
Measurements: to be used by OMCLs for activities other than compliance testing.
4. General Notices, 1.4 Monographs, Limits, European Pharmacopoeia.
5. II. Introduction, General Principles, European Pharmacopoeia.
6. Validation of Analytical Procedures – Text and Methodology. ICH Guideline.
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
7. OMCL Guideline "Validation of Analytical Procedures".
8. OMCL Guideline "Evaluation and Reporting of Results”.
9. OMCL Guideline "Chemical Reference Substances used as Assay Standards".
10. Chromatographic Separation Techniques (2.2.46), European Pharmacopoeia.
11. Statistical Analysis of Results, Biological Assays and Tests (5.3), European Pharmacopoeia.
12. EA guidelines on the expression of uncertainty in quantitative testing, EA-4/16.
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8. APPENDIX
Flow chart for evaluation of measurement uncertainty in compliance testing
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