This document discusses analytical quality control (AQC) and internal quality control (IQC) processes for ensuring accurate laboratory analysis. It describes how AQC involves all processes designed to ensure consistent, comparable, and accurate results within certain limits. IQC is important for maintaining accuracy of results over time by analyzing control samples alongside test samples. The document recommends a three-phase IQC design with the goals of high error detection, low false rejection rates, and defining the duration of analytical runs using integrated normal patient data. Quality control samples should have similar matrices to samples, be easy to use, stable, available in sufficient quantities, and have target values close to samples.
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.
Overview of analytical method validationprarkash_dra
This document provides an overview of analytical method validation in the pharmaceutical industry. It discusses key aspects of method validation including specificity, linearity, range, detection limit, quantitation limit, accuracy, and precision. Validation is important to demonstrate that an analytical method is suitable for its intended use in accurately measuring the quality of pharmaceutical products. The document outlines recommended approaches for establishing performance characteristics during the validation process.
The document discusses various aspects of validation including calibration, process validation, analytical method validation, and cleaning validation. It defines validation as a systematic approach to collecting and analyzing data to give reasonable assurance that a process will consistently produce results within predetermined specifications. It describes the scope, organization, and types of validation including process, analytical method, cleaning, and computer system validation. It also discusses key aspects of analytical method validation like accuracy, precision, specificity, linearity, repeatability, intermediate precision, and robustness.
Review on Bioanalytical Method Development in Human Plasmaijtsrd
1. The document discusses bioanalytical method development and validation which is important for quantifying drug and metabolite concentrations in biological samples like plasma.
2. Key parameters that are validated for a bioanalytical method include selectivity, accuracy, precision, linearity, limits of detection/quantification, recovery, robustness and stability.
3. There are three types of validation - full validation for a new method/drug, partial validation for modifications to an existing method, and cross-validation to compare different methods analyzing the same samples. Validated methods must be used to generate reliable results for clinical and nonclinical studies.
THE CONCEPT OF TRACEABILITY IN LABORATORY MEDICINE - A TOOL FOR STANDARDISATIONMoustafa Rezk
The document discusses the concept of traceability in laboratory medicine. It provides an overview of how traceability developed through the work of organizations like NIST and NCCLS. Traceability means relating measurement values to international standards through an unbroken chain of comparisons. This ensures accuracy and comparability of results across laboratories and diagnostic methods. The key aspects of traceability include certified reference materials, reference measurement procedures, and qualified reference laboratories. Traceability is important for standardization in laboratory medicine and compliance with regulations like the EU IVD directive.
Quality control and quality assurance are important for ensuring accurate lab results. Quality control involves regularly testing controls of known values to monitor a test's performance. Key quality control statistics include the mean and standard deviation, which are used to calculate control limits on a Levey-Jennings chart. Westgard rules provide standards for determining when a test is out of control based on control values. Quality assurance encompasses the overall programs and procedures that a lab follows to ensure accurate and reliable results. It has strategic, tactical, and operational levels.
This document discusses the validation of bioanalytical methods. It defines validation as demonstrating the performance and reliability of an analytical method. There are three types of validation: full validation for new methods, partial validation for modifications to existing methods, and cross-validation to compare two methods. Key validation characteristics discussed include selectivity, accuracy, precision, linearity, stability, carryover, matrix effects, and recovery. Proper validation of bioanalytical methods is necessary to ensure reliable results.
This document discusses validation in the pharmaceutical industry. It begins by defining validation as establishing evidence that a process maintains compliance. It then discusses why validation is important, including that regulatory agencies require validation to ensure consistent, reproducible results. It outlines the types of validation including equipment, facilities, analytical methods, and more. It focuses on analytical method validation, discussing parameters like accuracy, precision, specificity, and more. It emphasizes that validation is necessary to confirm analytical procedures consistently produce the intended results.
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.
Overview of analytical method validationprarkash_dra
This document provides an overview of analytical method validation in the pharmaceutical industry. It discusses key aspects of method validation including specificity, linearity, range, detection limit, quantitation limit, accuracy, and precision. Validation is important to demonstrate that an analytical method is suitable for its intended use in accurately measuring the quality of pharmaceutical products. The document outlines recommended approaches for establishing performance characteristics during the validation process.
The document discusses various aspects of validation including calibration, process validation, analytical method validation, and cleaning validation. It defines validation as a systematic approach to collecting and analyzing data to give reasonable assurance that a process will consistently produce results within predetermined specifications. It describes the scope, organization, and types of validation including process, analytical method, cleaning, and computer system validation. It also discusses key aspects of analytical method validation like accuracy, precision, specificity, linearity, repeatability, intermediate precision, and robustness.
Review on Bioanalytical Method Development in Human Plasmaijtsrd
1. The document discusses bioanalytical method development and validation which is important for quantifying drug and metabolite concentrations in biological samples like plasma.
2. Key parameters that are validated for a bioanalytical method include selectivity, accuracy, precision, linearity, limits of detection/quantification, recovery, robustness and stability.
3. There are three types of validation - full validation for a new method/drug, partial validation for modifications to an existing method, and cross-validation to compare different methods analyzing the same samples. Validated methods must be used to generate reliable results for clinical and nonclinical studies.
THE CONCEPT OF TRACEABILITY IN LABORATORY MEDICINE - A TOOL FOR STANDARDISATIONMoustafa Rezk
The document discusses the concept of traceability in laboratory medicine. It provides an overview of how traceability developed through the work of organizations like NIST and NCCLS. Traceability means relating measurement values to international standards through an unbroken chain of comparisons. This ensures accuracy and comparability of results across laboratories and diagnostic methods. The key aspects of traceability include certified reference materials, reference measurement procedures, and qualified reference laboratories. Traceability is important for standardization in laboratory medicine and compliance with regulations like the EU IVD directive.
Quality control and quality assurance are important for ensuring accurate lab results. Quality control involves regularly testing controls of known values to monitor a test's performance. Key quality control statistics include the mean and standard deviation, which are used to calculate control limits on a Levey-Jennings chart. Westgard rules provide standards for determining when a test is out of control based on control values. Quality assurance encompasses the overall programs and procedures that a lab follows to ensure accurate and reliable results. It has strategic, tactical, and operational levels.
This document discusses the validation of bioanalytical methods. It defines validation as demonstrating the performance and reliability of an analytical method. There are three types of validation: full validation for new methods, partial validation for modifications to existing methods, and cross-validation to compare two methods. Key validation characteristics discussed include selectivity, accuracy, precision, linearity, stability, carryover, matrix effects, and recovery. Proper validation of bioanalytical methods is necessary to ensure reliable results.
This document discusses validation in the pharmaceutical industry. It begins by defining validation as establishing evidence that a process maintains compliance. It then discusses why validation is important, including that regulatory agencies require validation to ensure consistent, reproducible results. It outlines the types of validation including equipment, facilities, analytical methods, and more. It focuses on analytical method validation, discussing parameters like accuracy, precision, specificity, and more. It emphasizes that validation is necessary to confirm analytical procedures consistently produce the intended results.
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.
The document summarizes the results of a within-laboratory analytical quality control exercise conducted with 30 laboratories analyzing standard solutions of nutrients from February 1997 to 1998. It found that while 70% of laboratories participated, the response time was slow and only around 50% of requested analyses were completed. Reasons for incomplete participation included unfamiliarity with quality control procedures, lack of necessary equipment and chemicals, and workload. The document evaluates the precision of results using coefficient of variation, finding some results less precise than quality control goals from published sources. It emphasizes the importance of quality control for obtaining reliable data.
Analytical methods validation as per ich & uspGANESH NIGADE
This document discusses analytical method validation as per ICH and USP guidelines. It defines validation as establishing documentary evidence that a procedure maintains compliance. Method validation involves demonstrating that an analytical procedure is suitable for its intended purpose by testing parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, ruggedness and robustness. It also discusses the different types of analytical procedures that require validation including identification tests, quantitative impurity tests, limit tests and assays.
This presentation include general introduction to validation of analytical method . analytical method validation include following points such as :
Introduction
Objective ,Types of analytical procedures to be validated,Validation parameters as per ICH and USP , cleaning validation , procedure , validation data, accuracy , range , precision, LOD, LOQ ,linearity, ruggedness , robustness
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. Quality guidelines cover stability testing, impurities, and Good Manufacturing Practice. Safety guidelines address carcinogenicity, genotoxicity, and non-clinical testing strategies. Efficacy guidelines relate to clinical trial design and reporting. Multidisciplinary guidelines include the medical terminology MedDRA and electronic data standards.
Quality by design in analytical method developmentpptxPriyankasananse1
This document summarizes a student presentation on quality by design in analytical method development. It discusses:
1) Why QbD is important for analytical methods to improve understanding, ease of improvement, and relationship to process control.
2) The key differences between traditional and QbD analytical method development, including use of an analytical target profile, design of experiments to understand method variables, and concept of a method lifecycle rather than one-time validation.
3) Tools used in QbD analytical method development like risk assessment, identification of critical quality attributes, method design, and qualification to ensure method performance.
Analytical Quality by Design Concise Review on Approach to Enhanced Analytica...ijtsrd
In the last few decades, the pharmaceutical industry has been rapidly progressing by focussing on various aspects of formulation and analytical development such as product Quality, Safety, and Efficacy. It is reflected through the increase in number of product development by the increased use of scientific tools such as QbD Quality by Design and PAT Process Analytical Technology . ICH guidelines Q8 to Q11 have specified QbD implementation in API synthetic process and also in formulation as well as analytical development. QbD has earned considerable reputation by formulation developers. It has enhanced the inculcation of scientific outlook and assessment of risks at an early stage. In this review, we have focussed on the implementation AQbD for API synthetic process and analytical methods development. AQbD key tools are identification of ATP Analytical Target Profile , CQA Critical Quality Attributes with risk assessment, and, MODR method operable design region . AQbD intends to provide product with highest quality through the minimisation of risks and also by providing good input for PAT approach. Thus, AQbD can act as an effective method towards innovative approach of Analytical Method Development along with meeting the necessary desired specifications. Bhosale Abhilash | Darekar Shubhangi | Dr. V. U Barge | Dr. Ashok Bhosale "Analytical Quality by Design: Concise Review on Approach to Enhanced Analytical Method Development" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-3 , April 2020, URL: https://www.ijtsrd.com/papers/ijtsrd30574.pdf Paper Url :https://www.ijtsrd.com/pharmacy/other/30574/analytical-quality-by-design-concise-review-on-approach-to-enhanced-analytical-method-development/bhosale-abhilash
Pharmaceutical Instrument and Analytical Validation and Qualification (SHOPNI...ShopnilAkash5
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages
It is essential to ensure the quality Of a product and Good Manufacturing Practices including all other regulatory requirements
JPBA published-a platform aQbD approach for multiple methods developmentJianmei Kochling
The document describes a platform analytical quality by design (AQbD) approach for developing multiple UHPLC-UV and UHPLC-MS methods for protein analysis. The AQbD approach provides a systematic process for understanding method scientific principles and ensures method robustness is built in during development. The knowledge and understanding gained from developing one method (UHPLC-UV peptide mapping) can be transferred to developing two other methods (UHPLC-MS oxidation method and UHPLC-UV C-terminal heterogeneity method) for analyzing the same protein. Following the AQbD approach helps generate reliable analytical methods that can provide high quality data to support product development and help avoid unnecessary post-approval changes.
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.
Improving Laboratory Performance Through Quality Control - The role of EQA in...Randox
Randox Quality Control's five simple steps to QC success. The second education guide from Randox QC for clinical laboratory staff. The guide will examine how EQA works, benefits of EQA and what a laboratory should look for when choosing an EQA scheme.
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Quality assurance and quality control programs are necessary to ensure the reliability and accuracy of analytical environmental data. An inter-laboratory study by the EPA showed wide variation in nutrient concentration measurements between laboratories. Measurement of total dissolved solids and electrical conductivity also showed significant variation between laboratories. Shewhart control charts can be used to monitor the statistical control of analytical procedures and identify sources of random and systematic error by tracking the spread and displacement of results from control samples over time. Control limits on the charts indicate thresholds for corrective action to maintain method accuracy.
Quality assurance and quality control programs are necessary to ensure the validity and reliability of analytical environmental data. Several studies have shown large variations in results for identical samples analyzed by different laboratories. AQC programs establish procedures for sample collection, analysis, calibration, quality control checks, and data reporting. Key aspects include standard methods, analyst training, instrument maintenance, calibration verification, internal quality control samples, and inter-laboratory sample exchanges to check for accuracy. Control charts can be used to monitor results and identify any loss of statistical control that could indicate errors have been introduced. Both precision and accuracy are important to consider when evaluating results.
Quality assurance and quality control programs are necessary to ensure the reliability and accuracy of analytical environmental data. An inter-laboratory study by the EPA showed wide variation in nutrient concentration measurements between laboratories. Measurement of total dissolved solids and electrical conductivity also showed significant variation between laboratories. Shewhart control charts can be used to monitor the statistical control of analytical procedures and identify issues by tracking results from quality control samples against mean values and standard deviations. Key aspects of a quality assurance program include sample handling procedures, standardized analytical methods, analyst training, instrument maintenance, calibration procedures, analytical quality control tests, data management, and control chart monitoring.
This document discusses validation in the pharmaceutical industry. It begins by defining validation and listing its objectives and advantages. It describes the need for validation and covers validation master plans, types of validation including process, cleaning, and equipment validation. It also discusses validation of specific dosage forms and calibration master plans. Finally, it addresses user requirement specifications, installation qualification, operational qualification, and performance qualification for facilities validation.
The document provides guidance on validation of analytical methods. It defines method validation as demonstrating that a method's performance characteristics meet requirements for intended use. All analytical methods for analyzing samples must be validated. The validation process involves developing a protocol, validating parameters like specificity, linearity, range, and accuracy, and documenting the results. Parameters to be validated depend on the type of test (e.g. assay, impurities identification). Acceptance criteria for characteristics like linearity, range, and accuracy are provided.
This document provides an overview of analytical method validation for biopharmaceuticals. It discusses the different types of analytical methods used in the biopharmaceutical industry, including screening methods, release and stability methods, and characterization methods. It emphasizes that method validation is important but guidelines have focused on validation for commercial products, leaving a gap for earlier stages of development. The document then discusses best practices for qualifying characterization methods and release/stability methods to demonstrate suitability for intended use during development.
The document discusses the life cycle of analytical methods from development through continued use. It proposes a new general chapter called "The Analytical Procedure Lifecycle" to provide a holistic framework. Key points include establishing analytical target profiles, assuring methods remain in a state of control, evaluating measurement uncertainty, and using quality-by-design to increase robustness and reduce lifecycle costs. Regular monitoring and trend analysis can identify needs for optimization or revalidation to ensure methods remain fit for their intended purpose over time.
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
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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.
The document summarizes the results of a within-laboratory analytical quality control exercise conducted with 30 laboratories analyzing standard solutions of nutrients from February 1997 to 1998. It found that while 70% of laboratories participated, the response time was slow and only around 50% of requested analyses were completed. Reasons for incomplete participation included unfamiliarity with quality control procedures, lack of necessary equipment and chemicals, and workload. The document evaluates the precision of results using coefficient of variation, finding some results less precise than quality control goals from published sources. It emphasizes the importance of quality control for obtaining reliable data.
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This document discusses analytical method validation as per ICH and USP guidelines. It defines validation as establishing documentary evidence that a procedure maintains compliance. Method validation involves demonstrating that an analytical procedure is suitable for its intended purpose by testing parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, ruggedness and robustness. It also discusses the different types of analytical procedures that require validation including identification tests, quantitative impurity tests, limit tests and assays.
This presentation include general introduction to validation of analytical method . analytical method validation include following points such as :
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Objective ,Types of analytical procedures to be validated,Validation parameters as per ICH and USP , cleaning validation , procedure , validation data, accuracy , range , precision, LOD, LOQ ,linearity, ruggedness , robustness
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. Quality guidelines cover stability testing, impurities, and Good Manufacturing Practice. Safety guidelines address carcinogenicity, genotoxicity, and non-clinical testing strategies. Efficacy guidelines relate to clinical trial design and reporting. Multidisciplinary guidelines include the medical terminology MedDRA and electronic data standards.
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This document summarizes a student presentation on quality by design in analytical method development. It discusses:
1) Why QbD is important for analytical methods to improve understanding, ease of improvement, and relationship to process control.
2) The key differences between traditional and QbD analytical method development, including use of an analytical target profile, design of experiments to understand method variables, and concept of a method lifecycle rather than one-time validation.
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In the last few decades, the pharmaceutical industry has been rapidly progressing by focussing on various aspects of formulation and analytical development such as product Quality, Safety, and Efficacy. It is reflected through the increase in number of product development by the increased use of scientific tools such as QbD Quality by Design and PAT Process Analytical Technology . ICH guidelines Q8 to Q11 have specified QbD implementation in API synthetic process and also in formulation as well as analytical development. QbD has earned considerable reputation by formulation developers. It has enhanced the inculcation of scientific outlook and assessment of risks at an early stage. In this review, we have focussed on the implementation AQbD for API synthetic process and analytical methods development. AQbD key tools are identification of ATP Analytical Target Profile , CQA Critical Quality Attributes with risk assessment, and, MODR method operable design region . AQbD intends to provide product with highest quality through the minimisation of risks and also by providing good input for PAT approach. Thus, AQbD can act as an effective method towards innovative approach of Analytical Method Development along with meeting the necessary desired specifications. Bhosale Abhilash | Darekar Shubhangi | Dr. V. U Barge | Dr. Ashok Bhosale "Analytical Quality by Design: Concise Review on Approach to Enhanced Analytical Method Development" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-3 , April 2020, URL: https://www.ijtsrd.com/papers/ijtsrd30574.pdf Paper Url :https://www.ijtsrd.com/pharmacy/other/30574/analytical-quality-by-design-concise-review-on-approach-to-enhanced-analytical-method-development/bhosale-abhilash
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Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages
It is essential to ensure the quality Of a product and Good Manufacturing Practices including all other regulatory requirements
JPBA published-a platform aQbD approach for multiple methods developmentJianmei Kochling
The document describes a platform analytical quality by design (AQbD) approach for developing multiple UHPLC-UV and UHPLC-MS methods for protein analysis. The AQbD approach provides a systematic process for understanding method scientific principles and ensures method robustness is built in during development. The knowledge and understanding gained from developing one method (UHPLC-UV peptide mapping) can be transferred to developing two other methods (UHPLC-MS oxidation method and UHPLC-UV C-terminal heterogeneity method) for analyzing the same protein. Following the AQbD approach helps generate reliable analytical methods that can provide high quality data to support product development and help avoid unnecessary post-approval changes.
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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
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quality assurance as well as novel analyzer technologies.
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Quality assurance and quality control programs are necessary to ensure the reliability and accuracy of analytical environmental data. An inter-laboratory study by the EPA showed wide variation in nutrient concentration measurements between laboratories. Measurement of total dissolved solids and electrical conductivity also showed significant variation between laboratories. Shewhart control charts can be used to monitor the statistical control of analytical procedures and identify sources of random and systematic error by tracking the spread and displacement of results from control samples over time. Control limits on the charts indicate thresholds for corrective action to maintain method accuracy.
Quality assurance and quality control programs are necessary to ensure the validity and reliability of analytical environmental data. Several studies have shown large variations in results for identical samples analyzed by different laboratories. AQC programs establish procedures for sample collection, analysis, calibration, quality control checks, and data reporting. Key aspects include standard methods, analyst training, instrument maintenance, calibration verification, internal quality control samples, and inter-laboratory sample exchanges to check for accuracy. Control charts can be used to monitor results and identify any loss of statistical control that could indicate errors have been introduced. Both precision and accuracy are important to consider when evaluating results.
Quality assurance and quality control programs are necessary to ensure the reliability and accuracy of analytical environmental data. An inter-laboratory study by the EPA showed wide variation in nutrient concentration measurements between laboratories. Measurement of total dissolved solids and electrical conductivity also showed significant variation between laboratories. Shewhart control charts can be used to monitor the statistical control of analytical procedures and identify issues by tracking results from quality control samples against mean values and standard deviations. Key aspects of a quality assurance program include sample handling procedures, standardized analytical methods, analyst training, instrument maintenance, calibration procedures, analytical quality control tests, data management, and control chart monitoring.
This document discusses validation in the pharmaceutical industry. It begins by defining validation and listing its objectives and advantages. It describes the need for validation and covers validation master plans, types of validation including process, cleaning, and equipment validation. It also discusses validation of specific dosage forms and calibration master plans. Finally, it addresses user requirement specifications, installation qualification, operational qualification, and performance qualification for facilities validation.
The document provides guidance on validation of analytical methods. It defines method validation as demonstrating that a method's performance characteristics meet requirements for intended use. All analytical methods for analyzing samples must be validated. The validation process involves developing a protocol, validating parameters like specificity, linearity, range, and accuracy, and documenting the results. Parameters to be validated depend on the type of test (e.g. assay, impurities identification). Acceptance criteria for characteristics like linearity, range, and accuracy are provided.
This document provides an overview of analytical method validation for biopharmaceuticals. It discusses the different types of analytical methods used in the biopharmaceutical industry, including screening methods, release and stability methods, and characterization methods. It emphasizes that method validation is important but guidelines have focused on validation for commercial products, leaving a gap for earlier stages of development. The document then discusses best practices for qualifying characterization methods and release/stability methods to demonstrate suitability for intended use during development.
The document discusses the life cycle of analytical methods from development through continued use. It proposes a new general chapter called "The Analytical Procedure Lifecycle" to provide a holistic framework. Key points include establishing analytical target profiles, assuring methods remain in a state of control, evaluating measurement uncertainty, and using quality-by-design to increase robustness and reduce lifecycle costs. Regular monitoring and trend analysis can identify needs for optimization or revalidation to ensure methods remain fit for their intended purpose over time.
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The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
Dynamics of Communal Politics in 21st Century India Challenges and Prospectsijtsrd
Communal politics in India has evolved through centuries, weaving a complex tapestry shaped by historical legacies, colonial influences, and contemporary socio political transformations. This research comprehensively examines the dynamics of communal politics in 21st century India, emphasizing its historical roots, socio political dynamics, economic implications, challenges, and prospects for mitigation. The historical perspective unravels the intricate interplay of religious identities and power dynamics from ancient civilizations to the impact of colonial rule, providing insights into the evolution of communalism. The socio political dynamics section delves into the contemporary manifestations, exploring the roles of identity politics, socio economic disparities, and globalization. The economic implications section highlights how communal politics intersects with economic issues, perpetuating disparities and influencing resource allocation. Challenges posed by communal politics are scrutinized, revealing multifaceted issues ranging from social fragmentation to threats against democratic values. The prospects for mitigation present a multifaceted approach, incorporating policy interventions, community engagement, and educational initiatives. The paper conducts a comparative analysis with international examples, identifying common patterns such as identity politics and economic disparities. It also examines unique challenges, emphasizing Indias diverse religious landscape, historical legacy, and secular framework. Lessons for effective strategies are drawn from international experiences, offering insights into inclusive policies, interfaith dialogue, media regulation, and global cooperation. By scrutinizing historical epochs, contemporary dynamics, economic implications, and international comparisons, this research provides a comprehensive understanding of communal politics in India. The proposed strategies for mitigation underscore the importance of a holistic approach to foster social harmony, inclusivity, and democratic values. Rose Hossain "Dynamics of Communal Politics in 21st Century India: Challenges and Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64528.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/history/64528/dynamics-of-communal-politics-in-21st-century-india-challenges-and-prospects/rose-hossain
Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in...ijtsrd
Background and Objective Telehealth has become a well known tool for the delivery of health care in Saudi Arabia, and the perspective and knowledge of healthcare providers are influential in the implementation, adoption and advancement of the method. This systematic review was conducted to examine the current literature base regarding telehealth and the related healthcare professional perspective and knowledge in the Kingdom of Saudi Arabia. Materials and Methods This systematic review was conducted by searching 7 databases including, MEDLINE, CINHAL, Web of Science, Scopus, PubMed, PsycINFO, and ProQuest Central. Studies on healthcare practitioners telehealth knowledge and perspectives published in English in Saudi Arabia from 2000 to 2023 were included. Boland directed this comprehensive review. The researchers examined each connected study using the AXIS tool, which evaluates cross sectional systematic reviews. Narrative synthesis was used to summarise and convey the data. Results Out of 1840 search results, 10 studies were included. Positive outlook and limited knowledge among providers were seen across trials. Healthcare professionals like telehealth for its ability to improve quality, access, and delivery, save time and money, and be successful. Age, gender, occupation, and work experience also affect health workers knowledge. In Saudi Arabia, healthcare professionals face inadequate expert assistance, patient privacy, internet connection concerns, lack of training courses, lack of telehealth understanding, and high costs while performing telemedicine. Conclusions Healthcare practitioners telehealth perceptions and knowledge were examined in this systematic study. Its collection of concerned experts different personal attitudes and expertise would help enhance telehealths implementation in Saudi Arabia, develop its healthcare delivery alternative, and eliminate frequent problems. Badriah Mousa I Mulayhi | Dr. Jomin George | Judy Jenkins "Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in Saudi Arabia: A Systematic Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64535.pdf Paper Url: https://www.ijtsrd.com/medicine/other/64535/assess-perspective-and-knowledge-of-healthcare-providers-towards-elehealth-in-saudi-arabia-a-systematic-review/badriah-mousa-i-mulayhi
The Impact of Digital Media on the Decentralization of Power and the Erosion ...ijtsrd
The impact of digital media on the distribution of power and the weakening of traditional gatekeepers has gained considerable attention in recent years. The adoption of digital technologies and the internet has resulted in declining influence and power for traditional gatekeepers such as publishing houses and news organizations. Simultaneously, digital media has facilitated the emergence of new voices and players in the media industry. Digital medias impact on power decentralization and gatekeeper erosion is visible in several ways. One significant aspect is the democratization of information, which enables anyone with an internet connection to publish and share content globally, leading to citizen journalism and bypassing traditional gatekeepers. Another aspect is the disruption of conventional media industry business models, as traditional organizations struggle to adjust to the decrease in advertising revenue and the rise of digital platforms. Alternative business models, such as subscription models and crowdfunding, have become more prevalent, leading to the emergence of new players. Overall, the impact of digital media on the distribution of power and the weakening of traditional gatekeepers has brought about significant changes in the media landscape and the way information is shared. Further research is required to fully comprehend the implications of these changes and their impact on society. Dr. Kusum Lata "The Impact of Digital Media on the Decentralization of Power and the Erosion of Traditional Gatekeepers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64544.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64544/the-impact-of-digital-media-on-the-decentralization-of-power-and-the-erosion-of-traditional-gatekeepers/dr-kusum-lata
Online Voices, Offline Impact Ambedkars Ideals and Socio Political Inclusion ...ijtsrd
This research investigates the nexus between online discussions on Dr. B.R. Ambedkars ideals and their impact on social inclusion among college students in Gurugram, Haryana. Surveying 240 students from 12 government colleges, findings indicate that 65 actively engage in online discussions, with 80 demonstrating moderate to high awareness of Ambedkars ideals. Statistically significant correlations reveal that higher online engagement correlates with increased awareness p 0.05 and perceived social inclusion. Variations across colleges and a notable effect of college type on perceived social inclusion highlight the influence of contextual factors. Furthermore, the intersectional analysis underscores nuanced differences based on gender, caste, and socio economic status. Dr. Kusum Lata "Online Voices, Offline Impact: Ambedkar's Ideals and Socio-Political Inclusion - A Study of Gurugram District" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64543.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64543/online-voices-offline-impact-ambedkars-ideals-and-sociopolitical-inclusion--a-study-of-gurugram-district/dr-kusum-lata
Problems and Challenges of Agro Entreprenurship A Studyijtsrd
Noting calls for contextualizing Agro entrepreneurs problems and challenges of the agro entrepreneurs and for greater attention to the Role of entrepreneurs in agro entrepreneurship research, we conduct a systematic literature review of extent research in agriculture entrepreneurship to overcome the study objectives of complications of agro entrepreneurs through various factors, Development of agriculture products is a key factor for the overall economic growth of agro entrepreneurs Agro Entrepreneurs produces firsthand large scale employment, utilizes the labor and natural resources, This research outlines the problems of Weather and Soil Erosions, Market price fluctuation, stimulates labor cost problems, reduces concentration of Price volatility, Dependency on Intermediaries, induces Limited Bargaining Power, and Storage and Transportation Costs. This paper mainly devoted to highlight Problems and challenges faced for the sustainable of Agro Entrepreneurs in India. Vinay Prasad B "Problems and Challenges of Agro Entreprenurship - A Study" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64540.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64540/problems-and-challenges-of-agro-entreprenurship--a-study/vinay-prasad-b
Comparative Analysis of Total Corporate Disclosure of Selected IT Companies o...ijtsrd
Disclosure is a process through which a business enterprise communicates with external parties. A corporate disclosure is communication of financial and non financial information of the activities of a business enterprise to the interested entities. Corporate disclosure is done through publishing annual reports. So corporate disclosure through annual reports plays a vital role in the life of all the companies and provides valuable information to investors. The basic objectives of corporate disclosure is to give a true and fair view of companies to the parties related either directly or indirectly like owner, government, creditors, shareholders etc. in the companies act, provisions have been made about mandatory and voluntary disclosure. The IT sector in India is rapidly growing, the trend to invest in the IT sector is rising and employment opportunities in IT sectors are also increasing. Therefore the IT sector is expected to have fair, full and adequate disclosure of all information. Unfair and incomplete disclosure may adversely affect the entire economy. A research study on disclosure practices of IT companies could play an important role in this regard. Hence, the present research study has been done to study and review comparative analysis of total corporate disclosure of selected IT companies of India and to put forward overall findings and suggestions with a view to increase disclosure score of these companies. The researcher hopes that the present research study will be helpful to all selected Companies for improving level of corporate disclosure through annual reports as well as the government, creditors, investors, all business organizations and upcoming researcher for comparative analyses of level of corporate disclosure with special reference to selected IT companies. Dr. Vaibhavi D. Thaker "Comparative Analysis of Total Corporate Disclosure of Selected IT Companies of India" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64539.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64539/comparative-analysis-of-total-corporate-disclosure-of-selected-it-companies-of-india/dr-vaibhavi-d-thaker
The Impact of Educational Background and Professional Training on Human Right...ijtsrd
This study investigated the impact of educational background and professional training on human rights awareness among secondary school teachers in the Marathwada region of Maharashtra, India. The key findings reveal that higher levels of education, particularly a master’s degree, and fields of study related to education, humanities, or social sciences are associated with greater human rights awareness among teachers. Additionally, both pre service teacher training and in service professional development programs focused on human rights education significantly enhance teacher’s knowledge, skills, and competencies in promoting human rights principles in their classrooms. Baig Ameer Bee Mirza Abdul Aziz | Dr. Syed Azaz Ali Amjad Ali "The Impact of Educational Background and Professional Training on Human Rights Awareness among Secondary School Teachers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64529.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64529/the-impact-of-educational-background-and-professional-training-on-human-rights-awareness-among-secondary-school-teachers/baig-ameer-bee-mirza-abdul-aziz
A Study on the Effective Teaching Learning Process in English Curriculum at t...ijtsrd
“One Language sets you in a corridor for life. Two languages open every door along the way” Frank Smith English as a foreign language or as a second language has been ruling in India since the period of Lord Macaulay. But the question is how much we teach or learn English properly in our culture. Is there any scope to use English as a language rather than a subject How much we learn or teach English without any interference of mother language specially in the classroom teaching learning scenario in West Bengal By considering all these issues the researcher has attempted in this article to focus on the effective teaching learning process comparing to other traditional strategies in the field of English curriculum at the secondary level to investigate whether they fulfill the present teaching learning requirements or not by examining the validity of the present curriculum of English. The purpose of this study is to focus on the effectiveness of the systematic, scientific, sequential and logical transaction of the course between the teachers and the learners in the perspective of the 5Es programme that is engage, explore, explain, extend and evaluate. Sanchali Mondal | Santinath Sarkar "A Study on the Effective Teaching Learning Process in English Curriculum at the Secondary Level of West Bengal" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd62412.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/62412/a-study-on-the-effective-teaching-learning-process-in-english-curriculum-at-the-secondary-level-of-west-bengal/sanchali-mondal
The Role of Mentoring and Its Influence on the Effectiveness of the Teaching ...ijtsrd
This paper reports on a study which was conducted to investigate the role of mentoring and its influence on the effectiveness of the teaching of Physics in secondary schools in the South West Region of Cameroon. The study adopted the convergent parallel mixed methods design, focusing on respondents in secondary schools in the South West Region of Cameroon. Both quantitative and qualitative data were collected, analysed separately, and the results were compared to see if the findings confirm or disconfirm each other. The quantitative analysis found that majority of the respondents 72 of Physics teachers affirmed that they had more experienced colleagues as mentors to help build their confidence, improve their teaching, and help them improve their effectiveness and efficiency in guiding learners’ achievements. Only 28 of the respondents disagreed with these statements. With majority respondents 72 agreeing with the statements, it implies that in most secondary schools, experienced Physics teachers act as mentors to build teachers’ confidence in teaching and improving students’ learning. The interview qualitative data analysis summarized how secondary school Principals use meetings with mentors and mentees to promote mentorship in the school milieu. This has helped strengthen teachers’ classroom practices in secondary schools in the South West Region of Cameroon. With the results confirming each other, the study recommends that mentoring should focus on helping teachers employ social interactions and instructional practices feedback and clarity in teaching that have direct measurable impact on students’ learning achievements. Andrew Ngeim Sumba | Frederick Ebot Ashu | Peter Agborbechem Tambi "The Role of Mentoring and Its Influence on the Effectiveness of the Teaching of Physics in Secondary Schools in the South West Region of Cameroon" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64524.pdf Paper Url: https://www.ijtsrd.com/management/management-development/64524/the-role-of-mentoring-and-its-influence-on-the-effectiveness-of-the-teaching-of-physics-in-secondary-schools-in-the-south-west-region-of-cameroon/andrew-ngeim-sumba
Design Simulation and Hardware Construction of an Arduino Microcontroller Bas...ijtsrd
This study primarily focuses on the design of a high side buck converter using an Arduino microcontroller. The converter is specifically intended for use in DC DC applications, particularly in standalone solar PV systems where the PV output voltage exceeds the load or battery voltage. To evaluate the performance of the converter, simulation experiments are conducted using Proteus Software. These simulations provide insights into the input and output voltages, currents, powers, and efficiency under different state of charge SoC conditions of a 12V,70Ah rechargeable lead acid battery. Additionally, the hardware design of the converter is implemented, and practical data is collected through operation, monitoring, and recording. By comparing the simulation results with the practical results, the efficiency and performance of the designed converter are assessed. The findings indicate that while the buck converter is suitable for practical use in standalone PV systems, its efficiency is compromised due to a lower output current. Chan Myae Aung | Dr. Ei Mon "Design Simulation and Hardware Construction of an Arduino-Microcontroller Based DC-DC High-Side Buck Converter for Standalone PV System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64518.pdf Paper Url: https://www.ijtsrd.com/engineering/mechanical-engineering/64518/design-simulation-and-hardware-construction-of-an-arduinomicrocontroller-based-dcdc-highside-buck-converter-for-standalone-pv-system/chan-myae-aung
Sustainable Energy by Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadikuijtsrd
Energy becomes sustainable if it meets the needs of the present without compromising the ability of future generations to meet their own needs. Some of the definitions of sustainable energy include the considerations of environmental aspects such as greenhouse gas emissions, social, and economic aspects such as energy poverty. Generally far more sustainable than fossil fuel are renewable energy sources such as wind, hydroelectric power, solar, and geothermal energy sources. Worthy of note is that some renewable energy projects, like the clearing of forests to produce biofuels, can cause severe environmental damage. The sustainability of nuclear power which is a low carbon source is highly debated because of concerns about radioactive waste, nuclear proliferation, and accidents. The switching from coal to natural gas has environmental benefits, including a lower climate impact, but could lead to delay in switching to more sustainable options. “Carbon capture and storage” can be built into power plants to remove the carbon dioxide CO2 emissions, but this technology is expensive and has rarely been implemented. Leading non renewable energy sources around the world is fossil fuels, coal, petroleum, and natural gas. Nuclear energy is usually considered another non renewable energy source, although nuclear energy itself is a renewable energy source, but the material used in nuclear power plants is not. The paper addresses the issue of sustainable energy, its attendant benefits to the future generation, and humanity in general. Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadiku "Sustainable Energy" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64534.pdf Paper Url: https://www.ijtsrd.com/engineering/electrical-engineering/64534/sustainable-energy/paul-a-adekunte
Concepts for Sudan Survey Act Implementations Executive Regulations and Stand...ijtsrd
This paper aims to outline the executive regulations, survey standards, and specifications required for the implementation of the Sudan Survey Act, and for regulating and organizing all surveying work activities in Sudan. The act has been discussed for more than 5 years. The Land Survey Act was initiated by the Sudan Survey Authority and all official legislations were headed by the Sudan Ministry of Justice till it was issued in 2022. The paper presents conceptual guidelines to be used for the Survey Act implementation and to regulate the survey work practice, standardizing the field surveys, processing, quality control, procedures, and the processes related to survey work carried out by the stakeholders and relevant authorities in Sudan. The conceptual guidelines are meant to improve the quality and harmonization of geospatial data and to aid decision making processes as well as geospatial information systems. The established comprehensive executive regulations will govern and regulate the implementation of the Sudan Survey Geomatics Act in all surveying and mapping practices undertaken by the Sudan Survey Authority SSA and state local survey departments for public or private sector organizations. The targeted standards and specifications include the reference frame, projection, coordinate systems, and the guidelines and specifications that must be followed in the field of survey work, processes, and mapping products. In the last few decades, there has been a growing awareness of the importance of geomatics activities and measurements on the Earths surface in space and time, together with observing and mapping the changes. In such cases, data must be captured promptly, standardized, and obtained with more accuracy and specified in much detail. The paper will also highlight the current situation in Sudan, the degree to which survey standards are used, the problems encountered, and the errors that arise from not using the standards and survey specifications. Kamal A. A. Sami "Concepts for Sudan Survey Act Implementations - Executive Regulations and Standards" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63484.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63484/concepts-for-sudan-survey-act-implementations--executive-regulations-and-standards/kamal-a-a-sami
Towards the Implementation of the Sudan Interpolated Geoid Model Khartoum Sta...ijtsrd
The discussions between ellipsoid and geoid have invoked many researchers during the recent decades, especially during the GNSS technology era, which had witnessed a great deal of development but still geoid undulation requires more investigations. To figure out a solution for Sudans local geoid, this research has tried to intake the possibility of determining the geoid model by following two approaches, gravimetric and geometrical geoid model determination, by making use of GNSS leveling benchmarks at Khartoum state. The Benchmarks are well distributed in the study area, in which, the horizontal coordinates and the height above the ellipsoid have been observed by GNSS while orthometric heights were carried out using precise leveling. The Global Geopotential Model GGM represented in EGM2008 has been exploited to figure out the geoid undulation at the benchmarks in the study area. This is followed by a fitting process, that has been done to suit the geoid undulation data which has been computed using GNSS leveling data and geoid undulation inspired by the EGM2008. Two geoid surfaces were created after the fitting process to ensure that they are identical and both of them could be counted for getting the same geoid undulation with an acceptable accuracy. In this respect, statistical operation played an important role in ensuring the consistency and integrity of the model by applying cross validation techniques splitting the data into training and testing datasets for building the geoid model and testing its eligibility. The geometrical solution for geoid undulation computation has been utilized by applying straightforward equations that facilitate the calculation of the geoid undulation directly through applying statistical techniques for the GNSS leveling data of the study area to get the common equation parameters values that could be utilized to calculate geoid undulation of any position in the study area within the claimed accuracy. Both systems were checked and proved eligible to be used within the study area with acceptable accuracy which may contribute to solving the geoid undulation problem in the Khartoum area, and be further generalized to determine the geoid model over the entire country, and this could be considered in the future, for regional and continental geoid model. Ahmed M. A. Mohammed. | Kamal A. A. Sami "Towards the Implementation of the Sudan Interpolated Geoid Model (Khartoum State Case Study)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63483.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63483/towards-the-implementation-of-the-sudan-interpolated-geoid-model-khartoum-state-case-study/ahmed-m-a-mohammed
Activating Geospatial Information for Sudans Sustainable Investment Mapijtsrd
Sudan is witnessing an acceleration in the processes of development and transformation in the performance of government institutions to raise the productivity and investment efficiency of the government sector. The development plans and investment opportunities have focused on achieving national goals in various sectors. This paper aims to illuminate the path to the future and provide geospatial data and information to develop the investment climate and environment for all sized businesses, and to bridge the development gap between the Sudan states. The Sudan Survey Authority SSA is the main advisor to the Sudan Government in conducting surveying, mappings, designing, and developing systems related to geospatial data and information. In recent years, SSA made a strategic partnership with the Ministry of Investment to activate Geospatial Information for Sudans Sustainable Investment and in particular, for the preparation and implementation of the Sudan investment map, based on the directives and objectives of the Ministry of Investment MI in Sudan. This paper comes within the framework of activating the efforts of the Ministry of Investment to develop technical investment services by applying techniques adopted by the Ministry and its strategic partners for advancing investment processes in the country. Kamal A. A. Sami "Activating Geospatial Information for Sudan's Sustainable Investment Map" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63482.pdf Paper Url: https://www.ijtsrd.com/engineering/information-technology/63482/activating-geospatial-information-for-sudans-sustainable-investment-map/kamal-a-a-sami
Educational Unity Embracing Diversity for a Stronger Societyijtsrd
In a rapidly changing global landscape, the importance of education as a unifying force cannot be overstated. This paper explores the crucial role of educational unity in fostering a stronger and more inclusive society through the embrace of diversity. By examining the benefits of diverse learning environments, the paper aims to highlight the positive impact on societal strength. The discussion encompasses various dimensions, from curriculum design to classroom dynamics, and emphasizes the need for educational institutions to become catalysts for unity in diversity. It highlights the need for a paradigm shift in educational policies, curricula, and pedagogical approaches to ensure that they are reflective of the diverse fabric of society. This paper also addresses the challenges associated with implementing inclusive educational practices and offers practical strategies for overcoming barriers. It advocates for collaborative efforts between educational institutions, policymakers, and communities to create a supportive ecosystem that promotes diversity and unity. Mr. Amit Adhikari | Madhumita Teli | Gopal Adhikari "Educational Unity: Embracing Diversity for a Stronger Society" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64525.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64525/educational-unity-embracing-diversity-for-a-stronger-society/mr-amit-adhikari
Integration of Indian Indigenous Knowledge System in Management Prospects and...ijtsrd
The diversity of indigenous knowledge systems in India is vast and can vary significantly between different communities and regions. Preserving and respecting these knowledge systems is crucial for maintaining cultural heritage, promoting sustainable practices, and fostering cross cultural understanding. In this paper, an overview of the prospects and challenges associated with incorporating Indian indigenous knowledge into management is explored. It is found that IIKS helps in management in many areas like sustainable development, tourism, food security, natural resource management, cultural preservation and innovation, etc. However, IIKS integration with management faces some challenges in the form of a lack of documentation, cultural sensitivity, language barriers legal framework, etc. Savita Lathwal "Integration of Indian Indigenous Knowledge System in Management: Prospects and Challenges" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63500.pdf Paper Url: https://www.ijtsrd.com/management/accounting-and-finance/63500/integration-of-indian-indigenous-knowledge-system-in-management-prospects-and-challenges/savita-lathwal
DeepMask Transforming Face Mask Identification for Better Pandemic Control in...ijtsrd
The COVID 19 pandemic has highlighted the crucial need of preventive measures, with widespread use of face masks being a key method for slowing the viruss spread. This research investigates face mask identification using deep learning as a technological solution to be reducing the risk of coronavirus transmission. The proposed method uses state of the art convolutional neural networks CNNs and transfer learning to automatically recognize persons who are not wearing masks in a variety of circumstances. We discuss how this strategy improves public health and safety by providing an efficient manner of enforcing mask wearing standards. The report also discusses the obstacles, ethical concerns, and prospective applications of face mask detection systems in the ongoing fight against the pandemic. Dilip Kumar Sharma | Aaditya Yadav "DeepMask: Transforming Face Mask Identification for Better Pandemic Control in the COVID-19 Era" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64522.pdf Paper Url: https://www.ijtsrd.com/engineering/electronics-and-communication-engineering/64522/deepmask-transforming-face-mask-identification-for-better-pandemic-control-in-the-covid19-era/dilip-kumar-sharma
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
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তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
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it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
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A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
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possible in the construction of test equipment,
although there are always some differences. The
results from the control items (control values) are in
the control chart list, and uncontrollable output should
be investigated and resolved. Great care is required in
determining the correct values for determining
statistical control limits, and this can only be
adequately measured during the normal application of
the analysis process. Conversely, targeted control
limits should be placed over objective fit and extend
those statistical control limits. An additional type of
internal quality control can be achieved by analyzing
duplicate test components of other actual test
samples. This gives a real scatter, but only refers to
the accuracy of the repetition. Another problem with
repetition is that the accuracy of the results often
varies depending on the analyst's focus.
IN THE LABORATORY
AQC processes are particularly important in
environmentally friendly sampling laboratories where
the concentration of existing chemicals may be very
low and close to the acquisition limit of the analysis
method. In well-managed laboratories, AQC
procedures are built on the normal operation of the
laboratory usually through the random introduction of
known standards in the sample stream or through the
use of nail-based samples.
Quality control begins with sample collection and
ends with data reporting. AQC is obtained through
the control of analytical laboratory operations. Initial
control of the complete system can be achieved
through the specification of laboratory services,
instrumentation, glassware, reagents, solvents, and
gases. However, daily performance tests should be
written down to ensure continuous production of
active data. First it should be checked to ensure that
the data should appear accurate and precise. Next,
systematic daily assessments such as spatial analysis,
measurement standards, quality control sample
samples, and references should be performed to
determine data reproduction. Testing helps to ensure
that the process measures what is in the sample.
The level of effort of each AQC can vary depending
on the training, professional pride, and the importance
of a particular project to a particular analyst. The
burden of each analyst from AQC efforts can be
reduced through quality assurance programs. With the
implementation of standard and standard quality
assurance systems, two key functions are achieved:
quality determination, and quality control. By
monitoring the accuracy and accuracy of the results,
the quality assurance system should increase
confidence in the reliability of the reported analysis
results, thus achieving adequate AQC.
The purpose of the development of the analysis
method is to obtain the identity, purity, physical
characteristics, and strength of the drug, which
includes drug bioavailability and stability.
Figure-1: analytical method development process
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Analytical quality control materials should have the following features;
Have the same / similar matrix as samples to be measured,
Easy to use because complex re-integration processes increase the risk of errors,
Is stable for a long time,
Available in sufficient quantities,
Have target values close to samples,
Internal quality control (IQC) is an important element of standardized analysis, which works to ensure that the
uncertainty of the results obtained during process validation is maintained for a long time. The IQC's main
method is to analyze the replacement material next to the test material in all analysis cases and thus address the
accuracy of the run to run (sub-set of VIM3 defined 'intermediate conditions'). This ‘regulatory importance’
should be similar to what is possible in the construction of test equipment, although there are always some
differences. Outcomes from control items (control values) are listed in the control chart, and outputs out of
control should be investigated and problems resolved. Great care is required in finding the right values for
determining statistical control limits, and this can only be adequately measured during the normal application of
the analysis process. Conversely, targeted control limits should be placed on purposeful merit and widen those
statistical control limits. An additional type of internal quality control can be achieved by analyzing duplicate
test components of other actual test samples. This gives a real scatter, but only refers to the accuracy of the
repetition. Another problem with duplication is that the accuracy of the results often varies depending on the
focus of the analyte.
PHARMACEUTICAL INDUSTRY
Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a
particular purpose. Common validation characteristics include: accuracy, precision (repeatability and
intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness. In cases
such as changes in synthesis of the drug substance, changes in composition of the finished product, and changes
in the analytical procedure, revalidation is necessary to ensure quality control.
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an
analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum,
chromatographic behavior, and chemical reactivity. Impurity testing can either be a quantitative test or a limit
test. Both tests should accurately measure the purity of the sample. Quantitative tests of either the active moiety
or other components of a sample can be conducted through assay procedures. Other analytical procedures such
as dissolution testing or particle size determination may also need to be validated and are equally important.
Purpose of QA / QC
Find accuracy and precision.
Demonstrating the absence of distractions.
Indicate the absence of contamination (from the sample machine, glassware, and reagents)
QC - Analytical Tools
Use quality control samples to identify problems and accuracy,
AND problem solving,
AND dealing with problems
Field Blank
Field blanks should be of the same quality as laboratory blanks. Stadium spaces should be at the same level as
laboratory spaces. Also called Trip Blank or Preservation Blank. It ensures that the source of the contamination
did not come from the contamination of the laboratory. Empty Goods - some stadium spaces are a real wash of
garden furniture, and it should be. These gaps may reflect other features beyond recognition.
Calibration Blank
Used to set the zero end of the measurement curve.
When contaminated, it can shake the whole curve - favoring the sample results to a lesser extent, especially
at lower concentrations.
Method Blank
A analyte matrix taken from the same process for preparing and analyzing the laboratory as samples.
The lab needs to set the reception distance conditions
Generally, if impurities are found in an empty path but less than 1/10 of the concentration concentrate, the
empty contamination method is ignored in that sample.
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Calibration Check Blank
Stainless steel (blank similar and used for measuring) should be used:
Immediately after measurement
Minimum frequency
after 10 samples
At the end of the update process
Estimating a set of functions that establish, under specified conditions, the relationship between the values
shown by the measurement tool or the measurement system, or the values represented by a significant measure
or reference item, and the corresponding values of the value obtained by the reference level.
Calibration can be carried out for three possible purposes viz.
1. Determining whether a particular instrument or standard is within certain tolerance with respect to deviation
from reference levels.
2. Reporting deviations from estimates based on general values.
3. Adjusting / adjusting the instrument or standard to restore it within the prescribed tolerance.
In the Measurement System In the weighing system, the following items will be explained.
1. Measurement planning
2. Standard and standard standards.
3. Measurement interval and adjustment limit
4. Measurement procedures
5. Action after measurement
6. Terms of use of measuring instrument
7. Measurement procedures
Quality Ratings
The quality of the measurements is understood in terms of accuracy and precision, based on system / random
errors in their sequence that are reflected in the repeated measurements. The most recent upgrade takes care of
both random and systematic errors and leads to a measure of uncertainty about the actual value. Accuracy is an
important parameter, and it is not the same as accuracy. Accuracy is the approximation of the real value
(measurement), while accuracy means the correlation between repetitive measurements (not always available).
Standard required:
ISO / IEC 17025: 2005 ‰ What are the technical requirements? Satisfaction is required to establish the technical
capacity of the Laboratory to perform the evaluation and evaluation functions of the Organization.
Note: Whatever we are talking about in these three days, one of the most important goals is to get the actual
parameter we want to measure (measured) as close as possible. In ISO / IEC 17025, Technical Requirements are
detailed in Section 5.0.
There are several quality control (QC) considerations that apply when using methods listed in EPA's Selected
Analytical Methods for Environmental Remediation and Recovery (SAM). Having appropriate quality analysis
data requires laboratories: (1) to perform the QC required to ensure that the measurement systems are properly
controlled and operational; (2) accurately record research results; and (3) documents appropriate to the QC
evaluation system for specific QC analysis, including corrective actions. Information about the EPA process for
data quality (DQO), consideration and planning is available in Quality Management Tools - Formal Planning.
See: EPA Quality Management Tools.
In addition to the fact that laboratories are able to produce accurate and precise data during site preparation, they
must be able to deliver results in a timely and efficient manner. Therefore, laboratories should be equipped with
standardized tools, appropriate standards, standardized testing procedures, and trained and qualified staff.
Laboratories should also be able to provide rapid changes in sample analysis and data reporting.
The quality or quantity of QC required during sample analysis and reporting depends on the intended purpose of
the data being produced (e.g., decisions to be made). Specific data processing requirements must be identified.
QC requirements and DQOs should be considered based on those requirements, and should be used consistently
in all laboratories where multiple laboratories are used. In almost all chemical warfare agents (CWAs), most
laboratories will not have access to standardized analysis and QC standards. The use of these agents is strictly
regulated by DoD and access is restricted. For information on laboratory analysis of samples containing CWAs
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or laboratory requirements in order to apply the most refined agent standards, please use the contact details
provided on the Environmental Response Laboratory Network (ERLN) website. See: ERN website.
A small set of QC analysis processes should be planned, documented and performed in all chemical tests. Other
QC specific requirements are defined in a number of individual ways and will be referred to any analytical
agreements designed to address specific analysts and sample types of concerns. Individual methods, samples and
analysis agreements or employment contract statements should also be consulted to determine which additional
QC may be required. QC analysis requirements usually include analyzing laboratory control samples to
document whether the analysis system is in control; matrix spikes to identify and measure the accuracy of the
worrying media rating system, and at levels of concern, the various gaps as a measure of freedom from
pollution; and matrix spike duplicates or sample duplicates to assess data accuracy.
In general, in order to evaluate chemical analysts, the appropriate QC includes initial demonstration of the
measurement system capability as well as continuous analysis of standards and other samples to ensure
continuous reliability of analysis results. Examples of relevant QCs include:
An indication that the measurement system is working properly
Initial measurement
Road spaces
Demonstrate the appropriateness of the analysis method for the intended use
Acquisition limits and amountAccuracy and recovery (ensure that the measurement system is accurate)
Analyze / matrix / QC level of anxiety-related samples (ensure that the rating system has adequate sensitivity
to anxiety levels)
Demonstration of the reliability of the continuous analysis method
Acquisition and accuracy of Matrix spike / matrix spike (MS / MSDs) accuracy
QC samples (system accuracy and concern levels of concern)
Surrogate nails (where applicable)
Ensuring continuous balancing
Road spaces
QC testing should comply with EPA Laboratory Ethics Standards and be performed as often as possible to
ensure the reliability of the results of the analysis. Additional guidelines can be found in Quality Management
Tools - Overview; in Chapter 1 of the EPA SW-846 "Solid Waste Testing Methods, Physical / Chemical
Methods"; and the EPA of 2005 "Laboratory Authorization Authorization Manual for Drinking Water" (EPA
815-R-05-004). As the identification of QC samples required, the frequency of QC samples should be
established based on DQO evaluation. The type and frequency of QC tests can be refined over time.
Good Laboratory Practice Standards
Quality Management Tools - Overview
EPA SW-846: Methods for Assessing Hazardous Waste
EPA 815-R-05-004: "Drinking Water Certification Manual Manual"
Ensuring data quality also requires that laboratory results be thoroughly tested and documented. The results of
the data quality assessment are included in the data report when they are passed on to decision makers. This
assessment is as important as the data to ensure informed and effective decisions. Although a certain level of
data testing is required in order to ensure data quality, 100% verification and / or verification is not required or
assisted in making effective decisions in emergencies. The level of this review should be determined based on
the specific case being assessed and the corresponding DQOs. In all cases, the QC levels and data updates
required to support decision-making should be determined. in advance of data collection as possible.
Within-run precision
At this point we should consider the exact meaning of the word ‘run’. Running is a set of experimental items that
are analyzed under repetitive conditions, i.e., during a ‘short period’. During the run, there should be no changes
in the size of the errors. However, repetition in that sense is a concept that has never been achieved. There are
always systematic changes during the run, however the time is short from the first to the last analysis. Therefore,
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in practice we must face 'unreasonable change' rather than 'no change'. We can do that bydealing with ‘repetitive
situations’ and ‘running’ as defined in parallel. For example, running mayinclude a sufficient number of test kits
to provide continuous analysis of three hours. We then treat the in-game variations as random and specify them
in repetition.
Between-run (‘intermediate’) precision
Internal quality control, however, is based on mid-run accuracy, close proximity to agreement between results
obtained in different analytical operations. This really has a much larger dispersion than the internal
performance, due to the additional source of error affecting each run in a different way. This supplement source
introduces uncontrollable changes such as those brought about by analyst modification, new reagents,
remodeling and changes in the laboratory environment. In order to quantify the normal deviation between
running smoothly, control items should be placed in random positions in the order of running analysis. If, for
example, control items were always in sequence, they would be analyzed as soon as the tool was weighed, with
little time for planned changes to appear. Repeated results will usually tend to underestimate the normal
deviation between initiation. Setting control limits Many textbooks tell us that control limits are determined by
the parameters (µ, σ) of the controlled process. However, we never know the parameters: we only know the
corresponding statistical values (x, s) calculated from the multiplied results. These differences have significant
implications that are often overlooked, and make setting up a control chart more difficult than expected. First, in
order to determine the actual rate of normal deviation between use, measurements should be repeated for
successive runs. The whole analysis process should be stopped from the beginning each time, for example by
opening equipment from the refrigerator, refining reagents, re-equipping etc, as appropriate. Control items
should be treated as standard test items will be in standard analysis tasks, i.e., integrated within the number of
test items. That will not happen as part of the verification for each session (it may take a few weeks) and is
actually done when normal activities are already in progress. So a practical strategy to start normal activities
with a temporary control chart. Such a chart may be based on multiplication sums (r) that are readily available
during verification, but with wider control lines than normal, in (specify) r and r from the definition. (This will
indicate the realization that between initiating normal deviation is usually r.) Control lines on that r and r can be
very small, leading to an excessive uncontrolled amount.
Basic principles and terminology he main goal of the IQC is to compare process performance with
expectations under sustainable performance.
Stable performance starts by checking the control elements over a period of time, and then counting the
definition and standard deviation (SD or s). Estimates are then progressively based on those same controls
and are compared to the actual distribution, usually by sorting them into control charts with defined
limitations defined, as well as extracting some SD duplicates (usually 2 and / or 3).
Unexpected values are identified to alert the analyst to possible changes in process performance. A control
chart is a graphical way of showing control results.
Control results are usually sorted according to the time or number of consecutive runs. Lines are usually
drawn from one point to another to emphasize any trends, formal shifts, or informal trips.
In health care laboratory applications, where the practice is to develop individual control rules, the control
chart is often referred to as the Levey-Jennings chart, although the use of individual control values is
presented by Henry and Segalove.10 a decision has been made regarding the state of control. The duration of
the analysis varies from system to system and laboratory to laboratory, depending on the stability of the
analysis system and its tendency to change, such as staff, reagents, re-measurements, or other factors that
may present problems.
Line control limits drawn on the control chart to provide graphical conditions for assessing whether the
measurement process is controlled or uncontrolled. These limits are usually calculated from the definition
and standard deviations determined under stable operation.
Regulatory law means the condition of a judicial decision whether the review is ongoing or not. It is usually
represented by 8 with the symbol of the AL form, where A is the sum of the numbers or represents the
number of control measures, and L indicates the control limits.
Therefore:. 13s means the control rule used with the Levey Jennings chart where the control limits are set as
meaning + 3s. Running is denied if a single control measure exceeds any control limit. . 12s means control
rule where control limits are set as mean + 2s. Shewhart is often considered.
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Figure-2: Flowchart and logic for the multi-rule internal quality control (IQC) procedure commonly
known as ‘Westgard rules’.
Planning strategies (doing the right IQC)
Quality is often defined as `doing the right thing '. IQC level depends on `doing the right IQC '. Right means
doing IQC with the correct number of control measures and applying the appropriate statistical control rules. The
second right refers to the proper use of the IQC by selecting the appropriate controls, calculating the appropriate
control data, setting the appropriate control parameters, translating the control data correctly and
Figure-3: a system of quality requirement and operating specifications
responding to good control signals. Proper IQC is related to planning and design. QC efficiency is related to the
proper use of QC design. General guidelines f or planning and design of IQC Procedures are provided by the
NCCLS (National Laboratory Laboratory Standards Committee). The steps to plan the QC statistics process are
presented as follows:
1. Explain the need for quality testing.
2. Determine the accuracy of the method and the bias.
3. Identify IQC candidate processes.
4. Guess IQC performance.
5. Set IQC performance standards.
6. Select the appropriate IQC process
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Figure-4: Quality planning and statargies control
Figure-5: Quality-control-strategy-implemented
REFERENCES:
[1] analytical quality control (AQC) program to
ensure the highest level of confidence in
reported data Archived March 28, 2012, at the
Way back Machine
[2] HANDBOOK FOR ANALYTICAL
QUALITY CONTROL IN WATER AND
WASTEWATER LABORATORIES Archived
November 14, 2013, at the Way back Machine
[3] https://en.wikipedia.org/wiki/Analytical_qualit
y_control
[4] Thompson, M., Magnusson, B. Methodology in
internal quality control of chemical analysis.
Accred Qual Assur 18, 271–278 (2013).
https://doi.org/10.1007/s00769-013-0955-1
[5] Hovind H, Magnussen B, Krysell M, Lund U,
Mäkinen I (2011) Internal quality control
handbook for chemical laboratories. Nordtest
Technical Report 569, 4th edn
[6] Westgard JO, Barry PL, Hunt MR (1981) Clin
Chem 27:493–501
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[7] Henry RJ, Segalove M. The running of
standards in clinical chemistry and the use of
the control chart. J Clin Pathol 1952; 5: 305-11
[8] Groth T, Falk H, Westgard JO. An interactive
computer simulation program for the design of
statistical control procedures in clinical
chemistry. Comput Programs Biomed 1981; 13:
73-86.
[9] Koch DD, Oryall JJ, Quam EF, Deldbruegge
DH, Dowd DE, Barry PL, et al. Selection of
medically useful quality-control procedures for
individual tests done in a multitest analytical
system. Clin Chem 1990; 36: 230-3.
[10] Ross JW, Boone DJ. Assessing the effect of
mistakes in the total testing process on the
quality of patient care. Proceedings 1989
Institute on Critical Issues in Health Laboratory
Practice. Atlanta, GA: Center for Disease
Control, 1991: 173.
[11] Levey S, Jennings ER. The use of control
charts in the clinical laboratory. Am J Clin
Pathol 1950; 20: 1059-66
[12] Plebani M, Carraro P. Mistakes in a stat
laboratory: types and frequency. Clin Chem
1997; 43: 1348-51.
[13] Marquis P, Masseyeff R. Evaluer une méthode
de contrôle de qualité interne: application au
contrôle multidimensionnel [Evaluating an
internal quality control procedure: application
to multidimensional control]. Ann Biol Clin
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PMID: 12368148.
[14] The National Institute of Standards and
Technology is a physical sciences laboratory
and non-regulatory agency of the United States
Department of Commerce.
https://nvlpubs.nist.gov/nistpubs/Legacy/IR/nbs
ir85-3105.pdf