Good Laboratory Practices (GLP) are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP aims to ensure study data accurately reflects results and is traceable. The regulations were established in response to discovered fraudulent activities and poor practices at toxicology labs in the 1970s. Facilities that do not comply with GLP standards risk disqualification, meaning they cannot conduct new studies or submit existing ones. Disqualified facilities can apply for reinstatement by demonstrating they will adhere to GLP procedures going forward.
GLP refers to Good Laboratory Practice, which are standards set by the FDA for conducting laboratory studies. GLP was created in the late 1970s after investigations found many cases of fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure laboratory data accurately reflects study results and is traceable. Facilities that do not comply with GLP standards risk disqualification, meaning they cannot conduct or submit studies to the FDA. Disqualification can occur if noncompliance affected study validity or a facility failed to improve after warnings.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with standards for facilities, equipment, record-keeping, personnel qualifications and quality control to avoid penalties for noncompliance like disqualification and inability to conduct future studies.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with requirements around facilities, equipment, recordkeeping, personnel qualifications and standard operating procedures to adhere to GLP. Noncompliance can result in disqualification and civil or criminal penalties for the laboratory.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure the quality and integrity of nonclinical safety data from laboratories. GLP provides a framework for how nonclinical studies are planned, performed, monitored, recorded, and reported. They apply to safety studies of products that are regulated by the FDA and EPA, such as pharmaceuticals, pesticides, and industrial chemicals. GLP regulations have since been adopted internationally through the OECD and individual countries to harmonize standards globally.
GLP refers to Good Laboratory Practice, which are standards set by the FDA for conducting laboratory studies. GLP was created in the late 1970s after investigations found many cases of fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure laboratory data accurately reflects study results and is traceable. Facilities that do not comply with GLP standards risk disqualification, meaning they cannot conduct or submit studies to the FDA. Disqualification can occur if noncompliance affected study validity or a facility failed to improve after warnings.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with standards for facilities, equipment, record-keeping, personnel qualifications and quality control to avoid penalties for noncompliance like disqualification and inability to conduct future studies.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with requirements around facilities, equipment, recordkeeping, personnel qualifications and standard operating procedures to adhere to GLP. Noncompliance can result in disqualification and civil or criminal penalties for the laboratory.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure the quality and integrity of nonclinical safety data from laboratories. GLP provides a framework for how nonclinical studies are planned, performed, monitored, recorded, and reported. They apply to safety studies of products that are regulated by the FDA and EPA, such as pharmaceuticals, pesticides, and industrial chemicals. GLP regulations have since been adopted internationally through the OECD and individual countries to harmonize standards globally.
The document discusses Good Laboratory Practices (GLP) which provide a framework for conducting laboratory studies on chemicals and pharmaceuticals. It outlines that GLP were established to ensure quality, consistency and integrity of safety testing. The key points covered include:
- GLP applies to nonclinical safety studies for chemicals and pharmaceuticals
- They help assure regulators that submitted data accurately reflects study results
- Major events leading to their creation in response to fraud and misconduct in some laboratories
The document discusses Good Laboratory Practices (GLP) which provide a framework for conducting laboratory studies. It was developed in response to fraudulent activities and poor practices discovered during FDA investigations of toxicology labs in the 1970s. GLP aims to ensure uniformity, quality and integrity of safety testing through management controls and adherence to standards for personnel, facilities, equipment, test methods and record keeping. Non-compliance can result in disqualification of a testing facility and rejection of any studies submitted to regulatory agencies.
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
Good Laboratory Practices (GLP) are quality standards for designing, conducting, recording, and reporting non-clinical research studies. GLP aims to ensure uniform and reliable testing conditions and accurate recording of results. It originated in response to fraudulent data submitted to regulatory agencies. Key aspects of GLP include standardized operating procedures, trained personnel, calibrated equipment, test article characterization, and maintenance of complete records. Facilities can be disqualified for GLP noncompliance, preventing submission of study data to regulators. Reinstatement requires corrective actions to ensure future compliance.
This document provides an overview of Good Laboratory Practice (GLP) standards. It defines GLP as a set of principles that provide a framework for conducting laboratory studies. GLP was established by the FDA in the 1970s after discovering fraudulent activities and poor practices in laboratories. GLP applies to nonclinical safety studies on chemicals, pharmaceuticals, and other products submitted to regulatory authorities. The document outlines the key components of GLP, including requirements for organization, personnel, facilities, equipment, testing operations, record keeping, and quality assurance. It also summarizes the various subparts and responsibilities defined in the 21 CFR part 58 GLP regulations.
The document provides information about Good Laboratory Practice (GLP) regulations. It begins by stating that GLP is an FDA regulation that provides a framework for conducting laboratory studies. It then discusses the history and reasons for the creation of GLP, including fraudulent activities and poor practices discovered during FDA inspections in the 1970s. Finally, it provides an overview of key aspects of GLP regulations, including definitions, requirements for facilities, equipment, study conduct, records, and reports.
The document discusses regulations for Good Laboratory Practice (GLP). It provides an overview of the history and development of GLP regulations, including reactions from the FDA and EPA to fraud and misinterpreted data. It describes key aspects of GLP regulations, such as requirements for facility management, personnel qualifications, the study director, quality assurance units, facilities, equipment, and computer systems. The document also discusses the applicability of GLP compared to other regulations like GCP, GMP, and Part 11.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP aims to ensure data submitted to regulatory authorities is accurate and traceable. The FDA investigation of laboratories in the 1970s uncovered fraudulent activities and poor practices that led to the creation of GLP. Key aspects of GLP include standard operating procedures, personnel qualifications, facility organization, equipment validation and maintenance of complete records. Noncompliance with GLP can result in the disqualification of a testing facility.
GLP (Good Laboratory Practices) regulations were established by the FDA in the late 1970s after investigations uncovered fraudulent practices and poor laboratory standards in toxicology testing submitted to the agency. The regulations provide a framework to ensure uniformity, quality and integrity of safety testing data. Noncompliance can result in disqualification of a testing facility, rejection of study data, and other consequences like public notification or legal action. A disqualified facility can apply for reinstatement by demonstrating corrective actions taken to assure future compliance.
GOOD LABORATORY PRACTICE by ILyas Mphil student.pptxAtaUrRahman50751
This document discusses Good Laboratory Practice (GLP) guidelines. It was prepared by Ilyas Ahamd and Siyar Khan, who are M.Phil scholars. GLP provides a framework for planning, conducting, monitoring, recording, reporting and archiving laboratory studies to ensure the safety of users, consumers and the environment. Key aspects of GLP include qualified personnel, validated equipment and methods, standard operating procedures, accurate documentation and record keeping, quality assurance programs, and facility organization and management. GLP aims to ensure data integrity and that results submitted to regulatory agencies accurately reflect what was found in studies.
The document provides information about audits, inspections, and compliance from the perspective of a Contract Research Organization (CRO). It discusses what a CRO is and different types of CROs. It outlines the importance of having a structured compliance plan and ensuring compliance with Good Laboratory/Clinical/Manufacturing Practices, applicable rules, regulations, and guidelines. The document emphasizes that quality control, monitoring, auditing, and inspections are necessary to ensure compliance and pass regulatory inspections. It provides tips for sites on preparing for and handling inspections by regulatory authorities like the FDA.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
This document provides an overview of Good Laboratory Practice (GLP) regulations. It discusses how GLP was created by the FDA in 1978 and adopted as international standards by the OECD. GLP aims to ensure safety study data quality and integrity by providing a framework for how studies should be planned, performed, monitored, and reported. The document reviews key GLP requirements such as management responsibility, personnel qualifications, facilities and equipment, standard operating procedures, quality assurance programs, and archiving study records. It emphasizes how following GLP principles helps to ensure internationally accepted non-clinical safety studies.
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
This document summarizes a presentation on handling out-of-specification (OOS) results from a scientific and regulatory perspective. It discusses the history of an OOS case involving Barr Laboratories, the phenomena and scenarios surrounding OOS results, and how to conduct OOS investigations. It provides guidance on classifying results as above the line, below the line, or within the line. It also discusses best practices for OOS investigations including conducting them in a timely, unbiased, and well-documented manner. The presentation emphasizes that OOS investigations should aim to determine the root cause and not to "test into compliance".
This document summarizes a presentation given by Cato Research, a full-service contract research organization. Cato provides drug development services globally with over 300 employees. They have therapeutic expertise across many disease areas. Cato ensures quality assurance through adherence to Good Laboratory Practice regulations, which require proper documentation, record keeping, and quality control procedures. The Quality Assurance Unit at Cato monitors studies and ensures compliance with regulations.
This document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of non-clinical laboratory studies. It was created by the FDA in 1978 after investigations found fraudulent activities and poor practices in toxicology labs. GLP provides principles for planning, conducting, monitoring, recording, reporting and archiving laboratory studies according to standard operating procedures to ensure the quality and integrity of data. Non-compliance with GLP can result in the disqualification of a testing facility, rejection of study data, and civil or criminal penalties.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
The document discusses Good Laboratory Practices (GLP) which provide a framework for conducting laboratory studies on chemicals and pharmaceuticals. It outlines that GLP were established to ensure quality, consistency and integrity of safety testing. The key points covered include:
- GLP applies to nonclinical safety studies for chemicals and pharmaceuticals
- They help assure regulators that submitted data accurately reflects study results
- Major events leading to their creation in response to fraud and misconduct in some laboratories
The document discusses Good Laboratory Practices (GLP) which provide a framework for conducting laboratory studies. It was developed in response to fraudulent activities and poor practices discovered during FDA investigations of toxicology labs in the 1970s. GLP aims to ensure uniformity, quality and integrity of safety testing through management controls and adherence to standards for personnel, facilities, equipment, test methods and record keeping. Non-compliance can result in disqualification of a testing facility and rejection of any studies submitted to regulatory agencies.
1) GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
2) WHY WAS GLP CREATED? • In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. • They discovered a lot fraudulent activities and a lot of poor lab practices. • Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
3) Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
4)GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
5) GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
6) "Good Laboratory Practice", or GLP for short, refers to a quality assurance system that is applied during the pre-clinical stage of research and development. Its aim is to test active ingredients under specific environmental conditions and over a defined period of time.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
Good Laboratory Practices (GLP) are quality standards for designing, conducting, recording, and reporting non-clinical research studies. GLP aims to ensure uniform and reliable testing conditions and accurate recording of results. It originated in response to fraudulent data submitted to regulatory agencies. Key aspects of GLP include standardized operating procedures, trained personnel, calibrated equipment, test article characterization, and maintenance of complete records. Facilities can be disqualified for GLP noncompliance, preventing submission of study data to regulators. Reinstatement requires corrective actions to ensure future compliance.
This document provides an overview of Good Laboratory Practice (GLP) standards. It defines GLP as a set of principles that provide a framework for conducting laboratory studies. GLP was established by the FDA in the 1970s after discovering fraudulent activities and poor practices in laboratories. GLP applies to nonclinical safety studies on chemicals, pharmaceuticals, and other products submitted to regulatory authorities. The document outlines the key components of GLP, including requirements for organization, personnel, facilities, equipment, testing operations, record keeping, and quality assurance. It also summarizes the various subparts and responsibilities defined in the 21 CFR part 58 GLP regulations.
The document provides information about Good Laboratory Practice (GLP) regulations. It begins by stating that GLP is an FDA regulation that provides a framework for conducting laboratory studies. It then discusses the history and reasons for the creation of GLP, including fraudulent activities and poor practices discovered during FDA inspections in the 1970s. Finally, it provides an overview of key aspects of GLP regulations, including definitions, requirements for facilities, equipment, study conduct, records, and reports.
The document discusses regulations for Good Laboratory Practice (GLP). It provides an overview of the history and development of GLP regulations, including reactions from the FDA and EPA to fraud and misinterpreted data. It describes key aspects of GLP regulations, such as requirements for facility management, personnel qualifications, the study director, quality assurance units, facilities, equipment, and computer systems. The document also discusses the applicability of GLP compared to other regulations like GCP, GMP, and Part 11.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP aims to ensure data submitted to regulatory authorities is accurate and traceable. The FDA investigation of laboratories in the 1970s uncovered fraudulent activities and poor practices that led to the creation of GLP. Key aspects of GLP include standard operating procedures, personnel qualifications, facility organization, equipment validation and maintenance of complete records. Noncompliance with GLP can result in the disqualification of a testing facility.
GLP (Good Laboratory Practices) regulations were established by the FDA in the late 1970s after investigations uncovered fraudulent practices and poor laboratory standards in toxicology testing submitted to the agency. The regulations provide a framework to ensure uniformity, quality and integrity of safety testing data. Noncompliance can result in disqualification of a testing facility, rejection of study data, and other consequences like public notification or legal action. A disqualified facility can apply for reinstatement by demonstrating corrective actions taken to assure future compliance.
GOOD LABORATORY PRACTICE by ILyas Mphil student.pptxAtaUrRahman50751
This document discusses Good Laboratory Practice (GLP) guidelines. It was prepared by Ilyas Ahamd and Siyar Khan, who are M.Phil scholars. GLP provides a framework for planning, conducting, monitoring, recording, reporting and archiving laboratory studies to ensure the safety of users, consumers and the environment. Key aspects of GLP include qualified personnel, validated equipment and methods, standard operating procedures, accurate documentation and record keeping, quality assurance programs, and facility organization and management. GLP aims to ensure data integrity and that results submitted to regulatory agencies accurately reflect what was found in studies.
The document provides information about audits, inspections, and compliance from the perspective of a Contract Research Organization (CRO). It discusses what a CRO is and different types of CROs. It outlines the importance of having a structured compliance plan and ensuring compliance with Good Laboratory/Clinical/Manufacturing Practices, applicable rules, regulations, and guidelines. The document emphasizes that quality control, monitoring, auditing, and inspections are necessary to ensure compliance and pass regulatory inspections. It provides tips for sites on preparing for and handling inspections by regulatory authorities like the FDA.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
Good Laboratory Practices (GLPs) are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide.
This document provides an overview of Good Laboratory Practice (GLP) regulations. It discusses how GLP was created by the FDA in 1978 and adopted as international standards by the OECD. GLP aims to ensure safety study data quality and integrity by providing a framework for how studies should be planned, performed, monitored, and reported. The document reviews key GLP requirements such as management responsibility, personnel qualifications, facilities and equipment, standard operating procedures, quality assurance programs, and archiving study records. It emphasizes how following GLP principles helps to ensure internationally accepted non-clinical safety studies.
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
This document summarizes a presentation on handling out-of-specification (OOS) results from a scientific and regulatory perspective. It discusses the history of an OOS case involving Barr Laboratories, the phenomena and scenarios surrounding OOS results, and how to conduct OOS investigations. It provides guidance on classifying results as above the line, below the line, or within the line. It also discusses best practices for OOS investigations including conducting them in a timely, unbiased, and well-documented manner. The presentation emphasizes that OOS investigations should aim to determine the root cause and not to "test into compliance".
This document summarizes a presentation given by Cato Research, a full-service contract research organization. Cato provides drug development services globally with over 300 employees. They have therapeutic expertise across many disease areas. Cato ensures quality assurance through adherence to Good Laboratory Practice regulations, which require proper documentation, record keeping, and quality control procedures. The Quality Assurance Unit at Cato monitors studies and ensures compliance with regulations.
This document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of non-clinical laboratory studies. It was created by the FDA in 1978 after investigations found fraudulent activities and poor practices in toxicology labs. GLP provides principles for planning, conducting, monitoring, recording, reporting and archiving laboratory studies according to standard operating procedures to ensure the quality and integrity of data. Non-compliance with GLP can result in the disqualification of a testing facility, rejection of study data, and civil or criminal penalties.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
2. GLP: GOOD LABORATORY
PRACTICE
GLP is an FDA regulation.
Definition: GLP embodies
a set of principles that
provides a framework
within which laboratory
studies are planned
performed, monitored,
reported and archived.
GLP is sometimes confused
with the standards of
laboratory safety like
wearing safety goggles.
3. HISTORY
GLP is a formal regulation that was created by the
FDA (United states food and drug administration) in
1978.
Although GLP originated in the United States , it had
a world wide impact.
Non-US companies that wanted to do business with
the United states or register their pharmacies in the
United States had to comply with the United States
GLP regulations.
They eventually started making GLP regulations in
their home countries.
In 1981 an organization named OECD (organization
for economic co-operation and development )
produced GLP principles that are international
standard.
4. WHY WAS GLP CREATED?
In the early 70’s FDA became
aware of cases of poor laboratory
practice all over the United States.
FDA decided to do an in-depth
investigation on 40 toxicology
labs.
They discovered a lot fraudulent
activities and a lot of poor lab
practices.
Examples of some of these poor
lab practices found were
1. Equipment not been calibrated to
standard form , therefore giving
wrong measurements.
2. Incorrect/inaccurate accounts of
the actual lab study
3. Inadequate test systems
5. FAMOUS EXAMPLE
One of the labs that went
under such an investigation
made headline news.
The name of the Lab was
Industrial Bio Test. This was a
big lab that ran tests for big
companies such as Procter and
Gamble.
It was discovered that mice
that they had used to test
cosmetics such as lotion and
deodorants had developed
cancer and died.
Industrial Bio Test lab threw
the dead mice and covered
results deeming the products
good for human consumption.
Those involved in production,
distribution and sales for the
lab eventually served jail time.
6. OBJECTIVES OF GLP
GLP makes sure that the data submitted
are a true reflection of the results that are
obtained during the study.
GLP also makes sure that data is
traceable.
Promotes international acceptance of
tests.
7. MISSION OF GLP
Test systems
Archiving of records and materials.
Apparatus, material and reagent facilities.
Quality assurance programs.
Performance of the study.
Reporting of study results.
Standard operating procedures (SOP)
Personnel and test facility organization
8. Standard Operating Procedures
(SOP)
Written procedures for a laboratories
program.
They define how to carry out protocol-
specified activities.
Most often written in a chronological
listing of action steps.
They are written to explain how the
procedures are suppose to work
9. SOP
Routine inspection, cleaning,
maintenance, testing and calibration.
Actions to be taken in response to
equipment failure.
Analytical methods
Definition of raw data
Keeping records, reporting, storage,
mixing, and retrieval of data
10. Statistical Procedures for Data
Evaluation
Statistical procedures are not simply
chosen from a text book
Practitioners in a particular field may
adopt certain standards which are deemed
acceptable within that field.
Regulatory agencies often describe
acceptable statistical procedures.
11. Instrumentation Validation
This is a process necessary for any
analytical laboratory.
Data produced by “faulty” instruments
may give the appearance of valid data.
The frequency for calibration, re-validation
and testing depends on the instrument
and extent of its use in the laboratory.
Whenever an instrument’s performance is
outside the “control limits” reports must
be discontinued
12. Instrument Validation (cont)
Equipment records should include:
Name of the equipment and manufacturer
Model or type for identification
Serial number
Date equipment was received in the
laboratory
Copy of manufacturers operating
instruction (s)
13. Reagent/ Materials Certification
This policy is to assure that reagents used
are specified in the standard operating
procedure.
Purchasing and testing should be handled
by a quality assurance program.
14. Reagents and Solutions cont
Requirements:
Reagents and solutions shall be labeled
Deteriorated or outdated reagents and
solutions shall not be used
Include Date opened
Stored under ambient temperature
Expiration date
15. Analyst Certification
Some acceptable proof of satisfactory
training and/or competence with specific
laboratory procedures must be established
for each analyst.
Qualification can come from education,
experience or additional trainings, but it
should be documented
Sufficient people
Requirements of certification vary
16. Laboratory Certification
Normally done by an external agency
Evaluation is concerned with issues such as
Adequate space
Ventilation
Storage
Hygiene
17. Specimen/Sample Tracking
Vary among laboratories
Must maintain the unmistakable
connection between a set of analytical
data and the specimen and/or samples
from which they were obtained.
Original source of specimen/sample (s)
must be recorded and unmistakably
connected with the set of analytical data.
18. Documentation and Maintenance of
Records
Maintenance of all records provide
documentation which may be required in the
event of legal challenges due to repercussions of
decisions based on the original analytical results.
General guidelines followed in regulated
laboratories is to maintain records for at least
five years
Length of time over which laboratory records
should be maintained will vary with the situation
19. Important questions to be answered for any
analytical instrument
What is the equipment being used for?
Is the instrument within specification and is the
documentation to prove this available?
If the instrument is not within specifications, how
much does it deviate by?
If the instrument is not within specifications what
action has been taken to overcome the defect?
Can the standards used to test and calibrate the
instrument be traced back to national standards?
20. What happens if a workplace
does not comply with federal
Good Laboratory Practice
standards?
21. Disqualification of a Facility
Before a workplace can experience the
consequences of noncompliance, an
explanation of disqualification is needed
The FDA states the purpose of
disqualification as the exclusion of a
testing facility from completing laboratory
studies or starting any new studies due to
not following the standards of compliance
set by the Good Laboratory Practice
manual
22. Possible Violations
Falsifying information for permit,
registration or any required records
Falsifying information related to testing~
protocols, ingredients, observations, data
equipment, ect.
Failure to prepare, retain, or submit
written records required by law
23. Grounds for Disqualification
The testing facility failed to comply with
one or more regulations implemented by
the GLP manual
The failure to comply led to adverse
outcomes in the data; in other words, it
affected the validity of the study
Warnings or rejection of previous studies
have not been adequate to improve the
facility’s compliance
24. Consequences of Noncompliance
The FDA states the following consequences of
noncompliance:
The commissioner will send a written proposal of
disqualification to the testing facility
A regulatory hearing on the disqualification will be
scheduled
If the commissioner finds that after the hearing, the
facility has complied, then a written statement with
an explanation of termination of disqualification will
be sent to the facility
Thus, if it can be shown that such disqualifications did
not affect the integrity and outcome of the study
itself, or did not occur at all, then the study may be
reinstated at the will of the commissioner
25. Upon Disqualification…
If the commissioner finds that the facility was
noncompliant on any of the grounds after the
hearing, then a final order of noncompliance will be
sent to the facility with explanations
If a testing facility has been disqualified, any studies
done before of after the disqualification will need to be
determined as essential to a decision (acceptable or not)
If the study is determined unacceptable, then the facility
itself may need to show that the study was not affected
by the noncompliance that led to the disqualification
Once finally disqualified, the facility may not receive or
be considered for a research or marketing permit and
the study is rejected.
26. Upon Disqualification…
The commissioner may notify the public and all
interested persons, including other federal agencies the
facility may have contacted
The FDA may ask the other agencies to consider
whether to support the facility or not under the
disqualification
Civil or criminal proceedings may occur at the discretion
of the commissioner
Fines of up to $50,000 if one knowingly commits crime
and/or 1 year imprisonment~ for registration applicants and
producers
Fines up to $5,000 all others~ civil penalty after failing to
improve after a minor violation warning was issued~ only
those involved in testing will be given civil penalties
Those involved in the distribution or sales will be assessed
more heavy penalties, such as criminal penalties
27. Upon Disqualification…
The FDA may turn it over to the federal,
state or local law enforcement
The facility’s sponsor may terminate or
suspend the facility from doing any non-
clinical study for a permit
The sponsor is required to notify the FDA
in writing within 15 working days that the
facility is to be suspended or terminated
and why
28. Reinstatement of a Disqualified
Facility
The testing facility may be reinstated as
acceptable non-clinical study to be turned into
the FDA if the commissioner can be certain that
future studies will be conducted in compliance
with the Good Laboratory Practice standards and
that any current studies integrity have not been
severely harmed by the disqualification
The disqualified facility will be required to put in
writing to the commissioner reasons why it
should be reinstated and any actions the facility
will take or have taken to assure any
disqualification problems will not happen again
29. Reinstatement of a Disqualified
Facility
The commissioner will inspect the facility
and determine if it shall be reinstated
If it is reinstated, the commissioner is
required to notify all persons that were
notified of the disqualification including
the facility itself