The document discusses Good Laboratory Practice (GLP) standards which are regulations for conducting non-clinical safety studies to support research and product approvals. It provides an overview of the history and development of GLP, describing how poor laboratory practices in the 1970s led the FDA to create formal GLP regulations in 1978. It also discusses the key principles of GLP for ensuring quality, integrity and traceability of non-clinical study data.
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 the history and importance of the OECD Principles of Good Laboratory Practice (GLP). It notes that GLP was established in response to fraudulent safety studies submitted to regulatory agencies. The OECD harmonized GLP standards across countries to ensure quality and integrity of nonclinical safety studies. The key aspects of GLP include organization, SOPs, facilities, personnel, test system handling, and record keeping. GLP aims to standardize nonclinical study practices to generate reliable and reproducible data for product safety assessments.
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.
Safety is the prime attention of regulatory bodies as it is the critical factor which can destroy even the humankind. Quality system like GLP has a lot tom play in the field of safety
assessments to reach its goal. There are various toxicity studies for assessing the degree of its toxicity. Academic research and peer reviewed journals has their own pitfalls as they could not
monitor or inspect the studies which has been conducted. This presentation speak about the Importance of safety assessment, various studies to evaluate the safety and Importance of GLP in safety assessment.
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.
The document discusses Good Laboratory Practice (GLP), which are quality standards for conducting non-clinical safety studies. It was created by the Organization for Economic Co-operation and Development (OECD) to ensure safety studies are conducted properly and results can be relied upon. Poor practices discovered by regulators in the 1970s, like fraudulent data and inaccurate record keeping, led to the formalization of GLP principles. Adhering to GLP helps generate reliable and reproducible safety data that can be shared internationally without non-tariff trade barriers. Key aspects of GLP covered include personnel responsibilities, facility organization requirements, and terms related to studies and quality assurance.
The document discusses the history and purpose of Good Laboratory Practices (GLP). GLP were established to ensure the quality and integrity of safety data submitted to regulatory agencies. Two notable cases of fraud and misconduct by toxicology labs in the 1970s prompted the FDA to institute GLP regulations in the US. These cases involved fabrication of data, removal of health findings, and other issues. GLP principles were later adopted by the OECD and involve certifying that non-clinical safety studies are properly planned, performed, monitored and reported.
Oecd principles of good laboratory practices (glp)Sriram Mamidi
The document discusses the OECD Principles of Good Laboratory Practice (GLP). It begins with an introduction to GLP and why it was created due to issues of poor laboratory practices discovered by the FDA in the 1970s. It then discusses the scope and principles of GLP established by the OECD, including test facility organization, quality assurance programs, facilities, equipment and materials, test systems, test and reference items, standard operating procedures, study conduct, reporting and storage. The principles are intended to ensure safety data from nonclinical studies are reliable and of high quality.
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 the history and importance of the OECD Principles of Good Laboratory Practice (GLP). It notes that GLP was established in response to fraudulent safety studies submitted to regulatory agencies. The OECD harmonized GLP standards across countries to ensure quality and integrity of nonclinical safety studies. The key aspects of GLP include organization, SOPs, facilities, personnel, test system handling, and record keeping. GLP aims to standardize nonclinical study practices to generate reliable and reproducible data for product safety assessments.
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.
Safety is the prime attention of regulatory bodies as it is the critical factor which can destroy even the humankind. Quality system like GLP has a lot tom play in the field of safety
assessments to reach its goal. There are various toxicity studies for assessing the degree of its toxicity. Academic research and peer reviewed journals has their own pitfalls as they could not
monitor or inspect the studies which has been conducted. This presentation speak about the Importance of safety assessment, various studies to evaluate the safety and Importance of GLP in safety assessment.
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.
The document discusses Good Laboratory Practice (GLP), which are quality standards for conducting non-clinical safety studies. It was created by the Organization for Economic Co-operation and Development (OECD) to ensure safety studies are conducted properly and results can be relied upon. Poor practices discovered by regulators in the 1970s, like fraudulent data and inaccurate record keeping, led to the formalization of GLP principles. Adhering to GLP helps generate reliable and reproducible safety data that can be shared internationally without non-tariff trade barriers. Key aspects of GLP covered include personnel responsibilities, facility organization requirements, and terms related to studies and quality assurance.
The document discusses the history and purpose of Good Laboratory Practices (GLP). GLP were established to ensure the quality and integrity of safety data submitted to regulatory agencies. Two notable cases of fraud and misconduct by toxicology labs in the 1970s prompted the FDA to institute GLP regulations in the US. These cases involved fabrication of data, removal of health findings, and other issues. GLP principles were later adopted by the OECD and involve certifying that non-clinical safety studies are properly planned, performed, monitored and reported.
Oecd principles of good laboratory practices (glp)Sriram Mamidi
The document discusses the OECD Principles of Good Laboratory Practice (GLP). It begins with an introduction to GLP and why it was created due to issues of poor laboratory practices discovered by the FDA in the 1970s. It then discusses the scope and principles of GLP established by the OECD, including test facility organization, quality assurance programs, facilities, equipment and materials, test systems, test and reference items, standard operating procedures, study conduct, reporting and storage. The principles are intended to ensure safety data from nonclinical studies are reliable and of high quality.
Good Laboratory Practice (GLP) is a quality system for research laboratories and organizations to ensure reliable and reproducible testing procedures. GLP was first introduced in the 1970s after cases of fraud were discovered in toxicology data submitted to regulatory agencies. The US FDA and EPA then established GLP regulations to improve testing standards and practices. The OECD principles of GLP aim to promote safety, consistency, and high quality testing of chemicals through non-clinical laboratory studies to facilitate international acceptance of test data. GLP provides requirements for laboratory organization, personnel, facilities, equipment, standard operating procedures, recordkeeping, and quality assurance practices.
Good Laboratory Practice (GLP) is a quality system for research laboratories and organizations to ensure uniformity, consistency, reliability, and integrity in non-clinical safety tests of products intended for human or animal use. GLP was first introduced in the 1970s and aims to promote safety and quality in non-clinical testing of chemicals, pharmaceuticals, and other products through management controls and adherence to standards for facilities, equipment, study design and reporting, record keeping, and personnel responsibilities. GLP applies internationally, including regulations from the US FDA and European Union.
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.
Good Laboratory Practice (GLP) regulations were created by the FDA in the 1970s in response to cases of poor laboratory practices and fraudulent activities in safety testing. GLP aims to ensure that non-clinical safety studies are well-planned, performed, monitored, recorded, and reported in a uniform manner to assure data quality and integrity. Key aspects of GLP include requirements for facilities, equipment, standard operating procedures, personnel training, test system characterization, record keeping, and quality assurance programs. Following GLP standards helps generate reliable and mutually accepted non-clinical data to support regulatory approval of products.
Speaker: Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc.
Topics Addressed
* Planning ahead to add credibility and value with your partners, investors and outside experts
* What is the landscape of various filings for a drug, a medical device or a diagnostic device?
* Developing a multi-disciplinary project team to manage your regulatory strategy:
o Different strategies for different products
o How to formulate a sound path to drug development decision-making
* What is needed for approval of a medical device
* The preclinical studies required for an IND filing
* The multiple components of the actual IND submission
* Management and communication between the teams assembling the IND
o When to outsource and bring in consultants
* Interacting with the regulatory authority
Download an audio file of this presentation at:
http://www.marsdd.com/bioent/jan15
Defined in the OECD Principles as: “...a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”
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 the process for approval of a new drug from development through marketing. It takes 10-15 years on average and costs over $2.6 billion to get a new drug approved. Key steps include:
- Preclinical research to identify biological targets and compounds
- FDA approval to begin clinical trials in three phases involving thousands of subjects to test safety, efficacy, and dosing
- New Drug Application submission including all clinical trial data for FDA review and approval
- Post-marketing studies and generic approval after patents expire
Good Laboratory Practice(GLP) by Kashikant YadavKashikant Yadav
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure quality and integrity of safety data from non-clinical health and environmental safety studies. GLP provides a framework for the organizational processes and conditions under which these studies are planned, performed, monitored, recorded, reported and archived. It aims to make sure data submitted to regulatory authorities is a true reflection of study results. Key aspects of GLP include requirements for facilities, equipment, test systems, personnel, standard operating procedures, study plans and reports. The overall goal of GLP is to promote quality test data for regulatory decision making.
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
Good laboratory practices (GLP) were established in the 1970s after fraudulent data was submitted to the FDA from toxicology laboratories. The key case involved Industrial Bio-Test Laboratories, which falsified safety tests. This led the FDA to create GLP regulations in 1978 to ensure non-clinical study data quality and integrity. The OECD later established universal GLP principles in 1981 to facilitate international acceptance of study data. GLP provides standards for test facility organization and quality management, facilities, test system handling, study conduct, reporting, and record keeping to ensure study data accurately represent results. India has established a National GLP Compliance Monitoring Authority to oversee adherence to GLP standards by domestic testing facilities.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
The fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
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.
Good Laboratory Practice (GLP) provides a framework for conducting laboratory studies in a standard manner. GLP was developed in response to fraudulent data submitted to the FDA from toxicology labs in the 1970s. The key standards developed were adopting standard operating procedures, maintaining accurate records, and ensuring oversight of studies. In 1981, the OECD formalized universal GLP principles to facilitate international acceptance of safety study data. GLP aims to ensure data integrity and reproducibility to support evidence-based decision making.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
This document discusses Good Laboratory Practices (GLP), which are quality standards for conducting non-clinical safety studies. It describes how GLP was established by the Organization for Economic Co-operation and Development and U.S. Food and Drug Administration to ensure study data integrity and reproducibility. GLP provides guidelines for facilities, equipment, personnel responsibilities, standard operating procedures, record keeping, and reporting to ensure studies are properly planned, performed, monitored, and documented. Adherence to GLP standards helps to ensure safety study data is reliable for regulatory assessment of chemicals, drugs, and other products.
हिंदी वर्णमाला पीपीटी, hindi alphabet PPT presentation, hindi varnamala PPT, Hindi Varnamala pdf, हिंदी स्वर, हिंदी व्यंजन, sikhiye hindi varnmala, dr. mulla adam ali, hindi language and literature, hindi alphabet with drawing, hindi alphabet pdf, hindi varnamala for childrens, hindi language, hindi varnamala practice for kids, https://www.drmullaadamali.com
Good Laboratory Practice (GLP) is a quality system for research laboratories and organizations to ensure reliable and reproducible testing procedures. GLP was first introduced in the 1970s after cases of fraud were discovered in toxicology data submitted to regulatory agencies. The US FDA and EPA then established GLP regulations to improve testing standards and practices. The OECD principles of GLP aim to promote safety, consistency, and high quality testing of chemicals through non-clinical laboratory studies to facilitate international acceptance of test data. GLP provides requirements for laboratory organization, personnel, facilities, equipment, standard operating procedures, recordkeeping, and quality assurance practices.
Good Laboratory Practice (GLP) is a quality system for research laboratories and organizations to ensure uniformity, consistency, reliability, and integrity in non-clinical safety tests of products intended for human or animal use. GLP was first introduced in the 1970s and aims to promote safety and quality in non-clinical testing of chemicals, pharmaceuticals, and other products through management controls and adherence to standards for facilities, equipment, study design and reporting, record keeping, and personnel responsibilities. GLP applies internationally, including regulations from the US FDA and European Union.
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.
Good Laboratory Practice (GLP) regulations were created by the FDA in the 1970s in response to cases of poor laboratory practices and fraudulent activities in safety testing. GLP aims to ensure that non-clinical safety studies are well-planned, performed, monitored, recorded, and reported in a uniform manner to assure data quality and integrity. Key aspects of GLP include requirements for facilities, equipment, standard operating procedures, personnel training, test system characterization, record keeping, and quality assurance programs. Following GLP standards helps generate reliable and mutually accepted non-clinical data to support regulatory approval of products.
Speaker: Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc.
Topics Addressed
* Planning ahead to add credibility and value with your partners, investors and outside experts
* What is the landscape of various filings for a drug, a medical device or a diagnostic device?
* Developing a multi-disciplinary project team to manage your regulatory strategy:
o Different strategies for different products
o How to formulate a sound path to drug development decision-making
* What is needed for approval of a medical device
* The preclinical studies required for an IND filing
* The multiple components of the actual IND submission
* Management and communication between the teams assembling the IND
o When to outsource and bring in consultants
* Interacting with the regulatory authority
Download an audio file of this presentation at:
http://www.marsdd.com/bioent/jan15
Defined in the OECD Principles as: “...a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”
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 the process for approval of a new drug from development through marketing. It takes 10-15 years on average and costs over $2.6 billion to get a new drug approved. Key steps include:
- Preclinical research to identify biological targets and compounds
- FDA approval to begin clinical trials in three phases involving thousands of subjects to test safety, efficacy, and dosing
- New Drug Application submission including all clinical trial data for FDA review and approval
- Post-marketing studies and generic approval after patents expire
Good Laboratory Practice(GLP) by Kashikant YadavKashikant Yadav
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure quality and integrity of safety data from non-clinical health and environmental safety studies. GLP provides a framework for the organizational processes and conditions under which these studies are planned, performed, monitored, recorded, reported and archived. It aims to make sure data submitted to regulatory authorities is a true reflection of study results. Key aspects of GLP include requirements for facilities, equipment, test systems, personnel, standard operating procedures, study plans and reports. The overall goal of GLP is to promote quality test data for regulatory decision making.
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
Good laboratory practices (GLP) were established in the 1970s after fraudulent data was submitted to the FDA from toxicology laboratories. The key case involved Industrial Bio-Test Laboratories, which falsified safety tests. This led the FDA to create GLP regulations in 1978 to ensure non-clinical study data quality and integrity. The OECD later established universal GLP principles in 1981 to facilitate international acceptance of study data. GLP provides standards for test facility organization and quality management, facilities, test system handling, study conduct, reporting, and record keeping to ensure study data accurately represent results. India has established a National GLP Compliance Monitoring Authority to oversee adherence to GLP standards by domestic testing facilities.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
The fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
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.
Good Laboratory Practice (GLP) provides a framework for conducting laboratory studies in a standard manner. GLP was developed in response to fraudulent data submitted to the FDA from toxicology labs in the 1970s. The key standards developed were adopting standard operating procedures, maintaining accurate records, and ensuring oversight of studies. In 1981, the OECD formalized universal GLP principles to facilitate international acceptance of safety study data. GLP aims to ensure data integrity and reproducibility to support evidence-based decision making.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
This document discusses Good Laboratory Practices (GLP), which are quality standards for conducting non-clinical safety studies. It describes how GLP was established by the Organization for Economic Co-operation and Development and U.S. Food and Drug Administration to ensure study data integrity and reproducibility. GLP provides guidelines for facilities, equipment, personnel responsibilities, standard operating procedures, record keeping, and reporting to ensure studies are properly planned, performed, monitored, and documented. Adherence to GLP standards helps to ensure safety study data is reliable for regulatory assessment of chemicals, drugs, and other products.
हिंदी वर्णमाला पीपीटी, hindi alphabet PPT presentation, hindi varnamala PPT, Hindi Varnamala pdf, हिंदी स्वर, हिंदी व्यंजन, sikhiye hindi varnmala, dr. mulla adam ali, hindi language and literature, hindi alphabet with drawing, hindi alphabet pdf, hindi varnamala for childrens, hindi language, hindi varnamala practice for kids, https://www.drmullaadamali.com
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
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.
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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2. Medical Testing Laboratory
patient care
clinical drug trial
Research Laboratory
discovery & development of new
drugs/therapy
fundamental research/mechanisms of
diseases
Manufacturing
post clinical trials, bulk drugs, cell-based
therapy, plasma products, medical device
3. Stage I Stage 2 Stage 3 Stage 4
Discovery Non-clinical Clinical Post-approval
Manufacturing
Time line approximately 10 yrs
4. Stage I : discovery of active substance
Stage II : non-clinical study on SAFETY
testing of drugs ,
Stage III : Studies in human/CLINICAL
TRIALS
Stage IV : Post approval Clinical trials
5. Pre Study
During Study
End of Study
Screening
Enrolment : inclusion
criteria exclusion
Verify effects of drugs
clinical efficacy
Monitoring of adverse
effects safety
Clinical efficacy
Data analysis
verification
8. Regulatory Authorities responsible for registering and
controlling pharmaceuticals request :
laboratory to demonstrate data in registration
package for a new chemical/drugs has been gathered
using ‘good laboratory practice’
require organisation be certified (or accredited) by a
third party for ‘GLP’
Organisations (researchers and medical laboratories)
often claimed that they are working under ‘glp’
Clients of laboratories often request that their work be
done using ‘good laboratory practice’
9. Apply when a non-clinical laboratory study
(e.g. Pre-Clinical animal testing) is intended
to support an application for an FDA-
regulated product.
GLP is an FDA regulation.
GLP embodies a set of principles that
provides a framework within which laboratory
studies are planned performed, monitored,
reported and archived.
GLP describes good practices for non-clinical
lab studies that support research or marketing
approvals for FDA-regulated products.
10. 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.
11. 1976 GLP guideline proposed
1978 GLP guideline finalised
1979 GLP guidelines effective
1987 additional changes ( Code of
Federal Regulation 21, part 58)
2000 : International GLP
12. 1970 1976 FDA GLP proposed
1978 FDA GLP regulations published
1980 1982 OECD GLP published (30 countries incl. U.S.),
UK GLP published, Japanese GLP published
1983 EPA GLP regulations published
1986 FDA GLP revised, European Union GLP
Directives
1989 EPA GLP revised
1990 1998 OECD GLPs revised, Canadian PMRA
adopted GLPs
2000 2002 OECD consensus document
2007 EPA may consolidate two parts of EPA GLPs
13. 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
14. 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.
15. Good Laboratory Practice standards
(GLPs) are federal regulations
mandated in the United States by:
• Food and Drug Administration (FDA)
in 21 CFR Part 58
• Environmental Protection Agency (EPA)
both for FIFRA in 40 CFR Part 160 and for
TSCA in 40 CFR Part 792
16. GLP = Good Laboratory Practice
GLP is a quality system concerned with the
organizational process and the conditions under
which non-clinical health and environmental
safety studies are planned, performed,
monitored, recorded, archived and reported.
OECD Principles on Good Laboratory Practice
What is the OECD?
19. Responsibility for establishing the safety
and efficacy of human and veterinary
drugs and devices, and the safety of food
and color additives is placed on the
sponsor (manufacturer) of the regulated
product.
20. Public agencies (FDA, EPA, OECD, etc) are
responsible for reviewing the sponsor’s test
results and determine if they demonstrate the
product’s safety and efficacy.
Only when the agencies are satisfied that
safety and efficacy have been established
adequately is the marketing of the product
permitted.
21. In vivo or in vitro experiments in which test articles
are studied prospectively in test systems under
laboratory conditions to determine their safety. The
term does not include studies utilizing human
subjects or clinical studies or field trials in animals.
The term does not include basic exploratory studies
carried out to determine whether a test article has
any potential utility or to determine physical or
chemical characteristics of a test article.
• 21 CFR Part 58.3(d)
22. GLP is needed for: GLP is not needed for:
•Nonclinical safety studies of
development of drugs
•Agricultural pesticide
development
•Development of toxic
chemicals
•Food control (food additives)
•Test of substance with regard
to explosive hazards
•Basic research
•Studies to develop new
analytical methods
•Chemical tests used to
derive the specifications of a
marketed food product
23. Purpose of GLPs: 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
Requires each study to have a study director
Study director: ultimate responsibility for
implementation of the protocol & conduct of
the study
24. Covers all nonclinical laboratory studies
Food & color additive petitions, NDA &
NADA
Toxicity studies (in vitro & in vivo)
Excluded: human subject trials, clinical or
field trials in animals, basic exploratory
studies
25. Sponsor: person who initiates & supports
nonclinical laboratory study, a person who
submits nonclinical study to FDA or testing
facility that initiates & conducts the study
Testing facility: person who actually
conducts a nonclinical laboratory study
Test system: any animal, plant, or
microorganism to which test or control article
is administered
26. Specimen: any material derived from a test
system for examination or analysis
Raw data: any laboratory work sheets,
records, memoranda, notes or copies that are
result of original observations
Quality assurance unit: monitor study
conduct
Study director: individual responsible for the
overall conduct of a nonclinical laboratory
study
27. formulated the first worldwide OECD Principles
of GLP 1981 ( revised in 1997)
Intergovernmental organization
30 industrialized countries
Meet to co-ordinate and harmonize policies.
Discuss issues of mutual concern
Work together to respond to international
problems.
Eliminate unnecessary duplication of
experiments
28. 1. Australia
2. Austria
3. Belgium
4. Canada
5. Czech
Republic
6. Denmark
7. Finland
8. France
9. Germany
10. Greece
21. Poland
22. Portugal
23. Slovak Republic
24. Spain
25. Sweden
26. Switzerland
27. Turkey
28. UK
29. USA
30. Norway
11. Hungary
12. Iceland
13. Ireland
14. Italy
15. Japan
16. Korea
17. Luxembourg
18. Mexico
19. Netherlands
20. New Zealand
29. 1981, Member countries
(31 member countries)
1997, Non-member
countries, full adherence
(4)
Non-member countries/
Provisional
Mutual Acceptance of
data
Compliance programme
Compliance programme
Malaysia launched in 2009
if full adherence GLP safety data
will be accepted by members
(31) & non-members (4)
30. OECD Principles of GLP: No.1
Guidance Documents for Compliance
Monitoring Authorities : No.2, 3 & 9
Consensus Documents : No.5-8, 10 & 13
Advisory Documents of the Working Group
on GLP : No.11, 12 & 14
http://www.oecd.org
31. 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.
to promote the development of quality and
validity of test data used for determining
the safety of chemicals and chemicals
product.
32. Study Integrity
-Reconstruction
-Proper data acceptance/rejection
Research Integrity
-Training of personnel
-Responsibilities
-Record security
-Checks and controls
-Confidentiality
Data Integrity
-Accuracy
-Completeness
-Consistency
33. Data points
Each non-clinical study
The regulatory submission
The work/career of an investigator
All of the research conducted at a laboratory
Public health, safety and confidence in scientific research
34. GLP should be applied to the non-clinical safety
testing of test items:
Pharmaceutical product
Pesticides product
Cosmetic product
Food additives
Feed additives
Industrial chemical
in the Laboratory, in greenhouses or in the field
35. Good Laboratory Practice applied in whatever
industry targeted, stresses the importance of the
following main points
Resources : Organisation, personnel, facilities,
equipment
Rules : Protocols, Standard Operating Procedures,
concept of Study Director
Characterisation : Test items, test systems
Documentation : Raw data, final report, archives
Quality Assurance : Independence from study conduct
36. 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
37. Physico-chemical properties
Toxicological studies designed to evaluate
human health effects
Ecotoxicological studies designed to
evaluate environmental effects
Ecological studies designed to evaluate
environmental chemical fate (transport,
biodegradation, and bioaccumulation)