Trách nhiệm của trưởng nhóm nghiên cứu trong bộ tiêu chuẩn GLP của OECD. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
The document outlines the fundamental points of Good Laboratory Practice (GLP) which include resources, characterization, rules, results, and quality assurance. GLP aims to standardize nonclinical safety studies to ensure reliability and integrity of study data. It requires organizations to have defined structures, qualified personnel, adequate facilities and equipment. Tests must characterize items and systems. Studies must follow approved protocols and standard operating procedures. All raw data, reports, and records must be retained to allow reconstruction of studies. Quality assurance independently monitors compliance.
This document discusses Good Laboratory Practice (GLP) regulations, which were established in the 1970s in response to malpractice in research and development. GLP regulations set standards for properly managing and organizing studies to generate regulatory data. The key points of GLP include ensuring adequate resources, characterizing test materials, following study plans and procedures, maintaining raw data and final reports, and implementing quality assurance programs. The Organization for Economic Cooperation and Development (OECD) later published GLP Principles that were adopted by its member states.
This document discusses the requirements for facilities under Good Laboratory Practice (GLP) regulations. It states that test facilities must be of appropriate size and construction to minimize disturbances that could affect study validity. There must be adequate separation of different activities through physical or organizational means. Specific facility requirements are outlined for housing test systems, handling test and reference items, storing records and samples, and disposing of waste. Calibrated apparatus must be maintained and suitable computer systems validated.
OECD Principle Of Good Laboratory Practice (GLP).pptxSIRAJUDDIN MOLLA
The document discusses the OECD Principles of Good Laboratory Practice (GLP). It begins by introducing GLP and its purpose of ensuring valid test data for determining chemical safety. It describes the development of the OECD GLP principles in 1979-1981. The document then covers the scope and definitions of key terms related to GLP. It provides details on 10 GLP principles regarding test facility organization, quality assurance programs, facilities, equipment, test systems, test items, standard operating procedures, study conduct, reporting, and record keeping.
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.
Good Laborarory Practices. Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.
The document discusses the MOD, which is an abbreviation that stands for Ministry of Defence in the United Kingdom. The MOD is responsible for implementing the defence policy set by Her Majesty's Government and the defence of the UK and overseas territories. It is the largest government department, employing over 100,000 full-time personnel and is responsible for defence policy, procurement, and the Armed Forces of the UK.
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
The document outlines the fundamental points of Good Laboratory Practice (GLP) which include resources, characterization, rules, results, and quality assurance. GLP aims to standardize nonclinical safety studies to ensure reliability and integrity of study data. It requires organizations to have defined structures, qualified personnel, adequate facilities and equipment. Tests must characterize items and systems. Studies must follow approved protocols and standard operating procedures. All raw data, reports, and records must be retained to allow reconstruction of studies. Quality assurance independently monitors compliance.
This document discusses Good Laboratory Practice (GLP) regulations, which were established in the 1970s in response to malpractice in research and development. GLP regulations set standards for properly managing and organizing studies to generate regulatory data. The key points of GLP include ensuring adequate resources, characterizing test materials, following study plans and procedures, maintaining raw data and final reports, and implementing quality assurance programs. The Organization for Economic Cooperation and Development (OECD) later published GLP Principles that were adopted by its member states.
This document discusses the requirements for facilities under Good Laboratory Practice (GLP) regulations. It states that test facilities must be of appropriate size and construction to minimize disturbances that could affect study validity. There must be adequate separation of different activities through physical or organizational means. Specific facility requirements are outlined for housing test systems, handling test and reference items, storing records and samples, and disposing of waste. Calibrated apparatus must be maintained and suitable computer systems validated.
OECD Principle Of Good Laboratory Practice (GLP).pptxSIRAJUDDIN MOLLA
The document discusses the OECD Principles of Good Laboratory Practice (GLP). It begins by introducing GLP and its purpose of ensuring valid test data for determining chemical safety. It describes the development of the OECD GLP principles in 1979-1981. The document then covers the scope and definitions of key terms related to GLP. It provides details on 10 GLP principles regarding test facility organization, quality assurance programs, facilities, equipment, test systems, test items, standard operating procedures, study conduct, reporting, and record keeping.
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.
Good Laborarory Practices. Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.
The document discusses the MOD, which is an abbreviation that stands for Ministry of Defence in the United Kingdom. The MOD is responsible for implementing the defence policy set by Her Majesty's Government and the defence of the UK and overseas territories. It is the largest government department, employing over 100,000 full-time personnel and is responsible for defence policy, procurement, and the Armed Forces of the UK.
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
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.
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.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a quality system for non-clinical health and environmental safety studies. The document outlines the history of GLP, elements of GLP including standard operating procedures and quality assurance units, objectives of GLP, scope of GLP application, and principles of GLP. It describes GLP as having four pillars: management, quality assurance, study director, and national compliance monitoring authorities. The goal of GLP is to ensure quality and integrity in laboratory studies submitted to regulatory authorities.
This document provides an overview of Good Laboratory Practice (GLP) principles established by the Organization for Economic Co-operation and Development (OECD). It discusses the key personnel involved in GLP studies including study directors, quality assurance personnel, and principal investigators. Facilities, equipment, test systems, standard operating procedures, study plans, and conduct of studies are also summarized in relation to adhering to GLP principles. The goal of GLP is to promote quality and validity of safety testing data for chemicals and products.
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
The document discusses Good Laboratory Practice (GLP) guidelines for conducting non-clinical laboratory studies. It provides an introduction to GLP, describing how the guidelines were developed by the FDA and OECD in response to issues with data integrity. It then summarizes key aspects of the US FDA, OECD, and Indian draft GLP guidelines regarding the scope, organization, roles and responsibilities of testing facility management, study directors, quality assurance units, principal investigators, and study personnel involved in GLP-compliant non-clinical studies.
The document discusses the application of Good Laboratory Practice (GLP) principles to in vitro studies. It outlines that the OECD developed GLP principles to promote valid safety testing data for chemicals. While many GLP requirements apply equally to in vitro and in vivo studies, some areas require special consideration for in vitro studies, such as test system handling and characterization, environmental control, and standard operating procedures. The document provides guidance on applying GLP requirements to facilities, equipment, materials, test systems, studies and record keeping for in vitro testing to ensure quality and integrity of safety data.
GLP (Good Laboratory Practice) is a quality system concerned with conducting non-clinical safety studies. It aims to ensure studies are accurately reported and not fraudulent. GLP has principles for organization, personnel, facilities, test systems, operating procedures, performance and reporting of studies. India's National GLP Compliance Monitoring Authority monitors adherence. GLP compliance certification is required for safety studies of products like pesticides, pharmaceuticals and food additives, and helps protect human and environmental health while facilitating international trade.
OECD principles of Good laboratory practice. this ppt include the basic and necessary information required for OECD GLP guideline . Content is taken from official site
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities
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 regulations were established in the 1970s in response to issues in pharmaceutical R&D. GLP provides a quality system for non-clinical studies by requiring organization, facilities, personnel, test characterization, study plans, and record-keeping. Key aspects of GLP include defining organizational structure and staff responsibilities, ensuring adequate facilities and equipment, documenting test materials and systems, having written protocols and procedures, recording raw data, archiving records, and independent quality assurance oversight of studies. GLP applies primarily to safety studies for products regulated by drug authorities.
This document provides guidance for a practical activity where students stain root tips and calculate the mitotic index. It includes instructions for preparing root tips from garlic cloves and hyacinth bulbs. Students will either vary the plant material or staining method used. Precise protocols are given for making lactopropionic orcein and toluidine blue stains. Students will examine slides under a microscope and calculate the mitotic index to draw conclusions about mitosis rates or staining efficiency. Advice is provided on meeting assessment criteria and potential extensions, such as varying experimental conditions.
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
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.
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.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a quality system for non-clinical health and environmental safety studies. The document outlines the history of GLP, elements of GLP including standard operating procedures and quality assurance units, objectives of GLP, scope of GLP application, and principles of GLP. It describes GLP as having four pillars: management, quality assurance, study director, and national compliance monitoring authorities. The goal of GLP is to ensure quality and integrity in laboratory studies submitted to regulatory authorities.
This document provides an overview of Good Laboratory Practice (GLP) principles established by the Organization for Economic Co-operation and Development (OECD). It discusses the key personnel involved in GLP studies including study directors, quality assurance personnel, and principal investigators. Facilities, equipment, test systems, standard operating procedures, study plans, and conduct of studies are also summarized in relation to adhering to GLP principles. The goal of GLP is to promote quality and validity of safety testing data for chemicals and products.
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
The document discusses Good Laboratory Practice (GLP) guidelines for conducting non-clinical laboratory studies. It provides an introduction to GLP, describing how the guidelines were developed by the FDA and OECD in response to issues with data integrity. It then summarizes key aspects of the US FDA, OECD, and Indian draft GLP guidelines regarding the scope, organization, roles and responsibilities of testing facility management, study directors, quality assurance units, principal investigators, and study personnel involved in GLP-compliant non-clinical studies.
The document discusses the application of Good Laboratory Practice (GLP) principles to in vitro studies. It outlines that the OECD developed GLP principles to promote valid safety testing data for chemicals. While many GLP requirements apply equally to in vitro and in vivo studies, some areas require special consideration for in vitro studies, such as test system handling and characterization, environmental control, and standard operating procedures. The document provides guidance on applying GLP requirements to facilities, equipment, materials, test systems, studies and record keeping for in vitro testing to ensure quality and integrity of safety data.
GLP (Good Laboratory Practice) is a quality system concerned with conducting non-clinical safety studies. It aims to ensure studies are accurately reported and not fraudulent. GLP has principles for organization, personnel, facilities, test systems, operating procedures, performance and reporting of studies. India's National GLP Compliance Monitoring Authority monitors adherence. GLP compliance certification is required for safety studies of products like pesticides, pharmaceuticals and food additives, and helps protect human and environmental health while facilitating international trade.
OECD principles of Good laboratory practice. this ppt include the basic and necessary information required for OECD GLP guideline . Content is taken from official site
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities
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 regulations were established in the 1970s in response to issues in pharmaceutical R&D. GLP provides a quality system for non-clinical studies by requiring organization, facilities, personnel, test characterization, study plans, and record-keeping. Key aspects of GLP include defining organizational structure and staff responsibilities, ensuring adequate facilities and equipment, documenting test materials and systems, having written protocols and procedures, recording raw data, archiving records, and independent quality assurance oversight of studies. GLP applies primarily to safety studies for products regulated by drug authorities.
This document provides guidance for a practical activity where students stain root tips and calculate the mitotic index. It includes instructions for preparing root tips from garlic cloves and hyacinth bulbs. Students will either vary the plant material or staining method used. Precise protocols are given for making lactopropionic orcein and toluidine blue stains. Students will examine slides under a microscope and calculate the mitotic index to draw conclusions about mitosis rates or staining efficiency. Advice is provided on meeting assessment criteria and potential extensions, such as varying experimental conditions.
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
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Danh mục được ban hành bới Cục Quản lý Dược Việt Nam tháng 7 năm 2023.
Ngày 21/06 vừa qua, cục Quản lý Dược vừa ban hành quyết định về việc công bố danh mục thuốc biệt dược gốc - đợt 2 năm 2023.
Ban hành kèm theo quyết định này bao gồm 83 thuốc biệt dược gốc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP-EU.
Hướng dẫn thực hành này cung cấp thông tin cho các nhà sản xuất thức ăn có chất sát khuẩn không an toàn do thuốc chuyển sang thức ăn chăn nuôi không chứa thuốc hoặc một loại thức ăn khác. Mục đích của hướng dẫn này:
• “Sản xuất và phân phối thức ăn có chứa thuốc” đề cập đến việc sử dụng thiết bị để sản xuất, chế biến, đóng gói, giữ và phân phối thức ăn.
• “Thức ăn chăn nuôi” được sản xuất có thêm hóa chất bảo quản. Thức ăn cho động vật như vậy có thể được gọi trong hướng dẫn này là “thức ăn có tẩm thuốc” hoặc “thức ăn không có tẩm thuốc”, tùy thuộc vào việc thức ăn đó có được pha chế để chứa một loại thuốc mới dành cho động vật hay không. Để thuận tiện, chúng tôi gọi những loại thuốc mới dành cho động vật này đơn giản là “thuốc”.
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• “Ô nhiễm không an toàn”: đề cập đến mức độ nhiễm bẩn, do một loại thuốc được phép sử dụng trong thức ăn chăn nuôi, gây ra rủi ro không thể chấp nhận được đối với sức khỏe con người hoặc động vật.
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Hướng dẫn này không bao gồm đầy đủ tất cả các quy định liên quan đến việc ghi nhãn sữa công thức dành cho trẻ sơ sinh. Vì vậy bạn có thể xem thêm các hướng dẫn khác tại www.fda.gov/FoodGuidances hoặc các tài liệu trên kênh của công ty cổ phần tư vấn thiết kế GMP EU.
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Theo đó, ban hành kèm theo Quyết định này danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 64 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 05 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 03 năm (Phụ lục II kèm theo).
Xem thêm các tài liệu khác trên trang của công tư cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược đã ban hành quyết định số 352/QĐ-QLD về việc ban hành danh mục 231 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đề nghị của Trưởng phòng Đăng ký thuốc, Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 231 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 172 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 52 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 03 năm (Phụ lục II kèm theo).
3. Danh mục 07 thuốc sản xuất trong nước được gia hạn đăng ký lưu hành đến 31/12/2025 (Phụ lục III kèm theo).
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược đã ban hành quyết định số 371/QĐ-QLD về việc công bố danh mục thuốc biệt dược gốc Đợt 1 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược, quyết định:
Công bố Danh mục 56 thuốc Biệt dược gốc Đợt 1 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược vừa ra quyết định số 370/QĐ-QLD về việc ban hành danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung, bao gồm:
1. Danh mục 41 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục I kèm theo).
2. Danh mục 01 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 03 năm - Đợt 111 bổ sung (tại Phụ lục II kèm theo).
3. Danh mục 07 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục III kèm theo).
4. Danh mục 01 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành đến 31/12/2025 - Đợt 111 bổ sung (tại Phụ lục IV kèm theo).
Ngày 24/05 vừa qua, Bộ Y tế vừa ban hành quyết định về việc công bố danh mục thuốc có chứng minh tương đương sinh học đợt 2 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục quản lý Dược, quyết định:
Công bố Danh mục 28 thuốc có chứng minh tương đương sinh học Đợt 2 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác của Công ty cổ phần Tư vấn thiết kế GMP EU.
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Trách nhiệm của trưởng nhóm nghiên cứu trong bộ tiêu chuẩn GLP của OECD
1. ENV/JM/MONO(99)24
Unclassified
Unclassified ENV/JM/MONO(99)24
Organisation de Coopération et de Développement Economiques OLIS : 14-Sep-1999
Organisation for Economic Co-operation and Development Dist. : 15-Sep-1999
Or. Eng.
ENVIRONMENT DIRECTORATE
JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY
ON CHEMICALS
OECD Series on Principles of GLP and Compliance Monitoring
Number 8 (Revised)
Consensus Document
THE ROLE AND RESPONSIBILITIES OF THE STUDY DIRECTOR
IN GLP STUDIES
81453
Document complet disponible sur OLIS dans son format d’origine
Complete document available on OLIS in its original format
Or.
Eng.
2. 2
REVISED CONSENSUS DOCUMENT
OECD SERIES
ON
PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING
Number 8 (revised)
GLP Consensus Document
THE ROLE AND RESPONSIBILITIES OF THE
STUDY DIRECTOR IN GLP STUDIES
Environment Directorate
ORGANISATIONFORECONOMICCO-OPERATIONANDDEVELOPMENT
Paris 1999
3. 3
FOREWORD
In the framework of the third OECD Consensus Workshop on Good Laboratory Practice held 5th to
8th October 1992 in Interlaken, Switzerland, a working group of experts discussed the interpretation of the
GLP Principles as applied to the role and responsibilities of the Study Director. This working group was
chaired by Dr. David F. Moore of the United Kingdom GLP Compliance Monitoring Authority; the
Rapporteur was Dr. Heinz Reust (Swiss FederalOffice of Public Health). Participants in the Working Group
were from both national GLP compliance monitoring authorities and from testing laboratories in the
following countries: Austria, Canada, Federation of Russia, Finland, Germany, Japan, Netherlands,
Switzerland, United Kingdom and United States.
The draft document developed by the working group was circulated to Member countries for
comments. The text was revised, based on comments received, and reviewed by the OECD Panel on Good
Laboratory Practice at its fifth meeting in March 1993, which amended the text and forwarded it to the Joint
Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of
Chemicals. At its 20th Session, the Joint Meeting endorsed the document with minor editorial changes and
recommended that it be derestricted under the authority of the Secretary-General.
In light of the adoption of the Revised OECD Principles of GLP in 1997, this Consensus Document
was reviewed by the Working Group on GLP and revised to make it consistent with modifications made to
the Principles. It was endorsed by the Working Group in April 1999 and, subsequently by the Joint Meeting
of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology in August
1999. . It too is declassified under the authority of the Secretary-General.
4. 4
CONTENTS
THE ROLE OF THE STUDY DIRECTOR............................................................................................7
MANAGEMENT RESPONSIBILITIES................................................................................................7
Appointment of Study Directors..........................................................................................................8
Training of Study Directors................................................................................................................8
RESPONSIBILITIES OF THE STUDY DIRECTOR............................................................................. 8
Study initiation..................................................................................................................................8
Study conduct....................................................................................................................................9
Final Report......................................................................................................................................9
Archives..........................................................................................................................................10
Sub-contracting...............................................................................................................................10
STUDY PLAN AMENDMENTS AND DEVIATIONS........................................................................10
Study Plan Amendment....................................................................................................................10
Study Deviations.............................................................................................................................10
QUALIFICATIONS OF THE STUDY DIRECTOR.............................................................................11
INTERFACE WITH THE STUDY......................................................................................................11
REPLACEMENT OF THE STUDY DIRECTOR.................................................................................11
LEGAL STATUS OF THE STUDY DIRECTOR.................................................................................12
5. 5
GLP CONSENSUS DOCUMENT
THE ROLE AND RESPONSIBILITIES OF THE STUDY DIRECTOR
IN GLP STUDIES
The Role ofthe Study Director
The Study Director represents the single point of study control with ultimate responsibility for the
overall scientific conduct of the study. This is the prime role of the Study Director, and all duties and
responsibilities as outlined in the GLP Principles stem from it. Experience has shown that unless
responsibility for the proper conduct of a study is assigned to one person, there is a potential for personnel to
receive conflicting instructions, which can result in poor implementation of the study plan. There can be only
one Study Director for a study at any given time. Although some of the duties of the Study Director can be
delegated, as in the case of a subcontracted study, the ultimate responsibility of the Study Director as the
single central point of control cannot.
In this regard, the Study Director serves to assure that the scientific, administrative and regulatory
aspects of the study are controlled. The Study Director accomplishes this by coordinating the inputs of
management, scientific/technical staff and the Quality Assurance programme.
In multi-site studies which involve work at more than one test site and the Study Director cannot
exercise immediate supervision, study procedures may be controlled by an appropriately trained, qualified
and experienced member of the staff, called the Principal Investigator. He is responsible for the conduct of
certain defined phases of the study in accordance with the applicable Principles of Good Laboratory Practice,
acting on behalf of the Study Director.
Scientifically, the Study Director is usually the scientist responsible for study plan design and
approval, as well as overseeing data collection, analysis and reporting. The Study Director is responsible for
drawing the final overall conclusions from the study. As the lead scientist, the Study Director must
coordinate with other study scientists, and/or Principal Investigator(s) keeping informed of their findings
during the study and receiving and evaluating their respective individual reports for inclusion in the final
study report.
Administratively, the Study Director must request and coordinate resources provided by
management, such as personnel, equipment and facilities, to ensure they are adequate and available as
scheduled for the proper conduct of the study.
Compliance with regulations is also the responsibility of the Study Director. In this role the Study
Director is responsible for ensuring that the study is carried out in accordance with the Principles of GLP,
which require the Study Director’s signature on the final study report to confirm compliance with the GLP
Principles.
Management Responsibilities
Management of a testing facility is responsible for ensuring that the facility operates in compliance
with GLP Principles. This responsibility includes the appointment and effective organisation of an adequate
6. 6
number of appropriately qualified and experienced staff throughout the facility, including Study Directors,
and, in the event of multi-site studies, Principal Investigator(s), if needed.
Appointment of Study Directors
Management should maintain a policy document defining the procedures adopted for selection and
appointment of Study Directors, their deputies, and Principal Investigator(s) if required by national
programmes.
When appointing a Study Director to a study, management should be aware of that person’s current
or anticipated workloads. The master schedule, which includes information on the type and timing of studies
allocated to each Study Director, can be used to assess the volume of work being performed by individuals
within the testing facility and is a useful management tool when allocating studies.
Replacement of a Study Director and/or Principal Investigator should be done according to
established procedures and should be documented.
Training of Study Directors
Management should ensure that there is documentation of training in all aspects of the Study
Director’s work. A training programme should ensure that Study Directors have a thorough understanding of
GLP Principles and an appropriate knowledge of testing facility procedures. This may include an awareness
and working knowledge of other guidelines and regulations pertinent to the testing facility and the particular
study type, for example, the OECD Test Guidelines. Training may include work experience under the
supervision of competent staff. Observation periods or work experience within each discipline involved in a
study can provide a useful basic understanding of relevant practical aspects and scientific principles, and
assist in the formation of communication links. Attendance at in-house and external seminars and courses,
membership in professional societies and access to appropriate literature may allow Study Directors to
maintain current awareness of developments within their scientific field. Professionaldevelopment should be
continuous and subject to periodic review. All training should be documented and records should be retained
for the period specified by the appropriate authorities.
Documented records of such a programme should reflect the progression of training and provide a
clear indication of the type of study that an individual is considered competent to direct. Further training or
retraining may be necessary from time to time, for example, following the introduction of new technology,
procedures or regulatory requirements.
Responsibilities ofthe Study Director
The Study Director is the individual who has overall responsibility for the scientific conduct of a
study and can confirm the compliance of the study with the OECD Principles of Good Laboratory Practice.
Study Initiation
7. 7
The Study Director has to approve the study plan which is prepared before study initiation by dated
signature. This document should clearly define the objectives and the whole conduct of the study and how
they are to be achieved. Any amendments to the study plan have to be approved as mentioned above. For a
8. 8
multi-site study the study plan should identify and define the role of any Principal Investigator(s) and any test
facilities and test sites involved in the conduct of the study.
The Study Director should take responsibility for the study by dated signature of the study plan, at
which stage the study plan becomes the official working document for that study (study initiation date). If
appropriate, the Study Director should also ensure that the study plan has been signed by the sponsor and the
management, if required by national programmes.
Before the study initiation date the Study Director should make the study plan available to Quality
Assurance (QA) staff for verifying that it contains all information required for compliance with the GLP
Principles.
Before the experimental starting date of the study, the Study Director should assure that copies of
the study plan are supplied to all personnel involved in the study; this should include Quality Assurance (QA)
staff.
Before any work on the study is undertaken, the Study Director should ascertain that management
have committed adequate resources toperform the study, and that adequate test materials and test systems are
available.
Study Conduct
The Study Director has responsibility for the overall conduct of the study and should ensure that the
procedures laid down in the study plan including amendments are followed and all data generated during the
study are fully documented. Specific technical responsibilities may be delegated to competent staff, and need
to be documented.
The Study Director’s involvement during the course of the study should include overviewing the
study procedures and data to ensure that the procedures laid down in the study plan are being followed and
that there is compliance with the relevant Standard Operating Procedures, and should include computer-
generateddata. In order to demonstrate this, the type and frequency of the reviews should be documented in
the study records.
As all decisions that may affect the integrity of the study should ultimately be approved by the
Study Director, it is important that he remains aware of the progress of the study. This is of particular
importance following temporary absence from the study and can only be achieved by maintaining effective
communication with all the scientific, technical and administrative personnel involved, and for a multi-site
study with Principal Investigator(s). Of necessity, lines of communication should ensure that deviations from
the study plan can be rapidly transmitted and that issues arising are documented.
If data are recorded on paper, the Study Director should ensure that the data generated are fully and
accurately documented and that they have been generated in compliance with GLP Principles. For data
recorded electronically onto a computerised system, the Study Director’s responsibilities are the same as for
paper systems. In addition, the Study Director should also ensure that computerised systems are suitable for
their intended purpose, have been validated, and are fit for use in the study.
Final Report
9. 9
The final report of a study should be produced as a detailed scientific document outlining the
purpose of the study, describing the methods and materials used, summarising and analysing data generated,
and stating the conclusions drawn.
10. 10
If the Study Director is satisfied that the report is a complete, true and accurate representation of the
study and its results, then and only then, should the Study Director sign and date the final report to indicate
acceptance of responsibility for the validity of the data. The extent of compliance with the GLP Principles
should be indicated. He should also assure himself that there is a QA statement and that any deviations from
the study plan have been noted.
Archives
On completion (including termination) of a study the Study Director is responsible for ensuring that
the study plan, final report, raw data and related material are archived in a timely manner. The final report
should include a statement indicating where all the samples of test and reference items, specimens, raw data,
study plan, final report and other related documentation are to be stored. Once data are transferred to the
archives, the responsibility for it lies with management.
Sub-contracting
Where parts of any study are contracted out, the Study Director (and QA staff) should have
knowledge of the GLP compliance status of that facility. If a contract facility is not GLP compliant, the
Study Director must indicate this in the final report.
Study Plan Amendments and Deviations
Study Plan Amendment
A study plan amendment should be issued to document an intended change in study design after the
study initiation date and before the event occurs. An amendment may also be issued as a result of unexpected
occurrences during the study that willrequire significant action. Amendments should indicate the reason for
the change and be sequentially numbered, dated, signed and distributed to all recipients of the original study
plan by the Study Director.
Study Deviations
Whereas an amendment is an intended change to the study plan, a deviation is an unintended
change which occurs during the execution of the study. Study information such as a deviation from the study
plan should be noted in the study documentation. Such notes may be initiated by other personnel involved in
the study, but should be acknowledged, described, explained and dated in a timely fashion by the Study
Director and/or Principal Investigator(s) and maintained with the study raw data. The Study Director should
approve any corrective action taken. The Study Director should consider whether to consult with other
scientists to determine the impact of any such information on the study, and should report (and discuss where
necessary) these deviations in the finalreport.
11. 11
Qualifications ofthe Study Director
Qualifications for a Study Director will be dictated by the requirements of each individual study.
Setting the criteria is the responsibility of the management. Furthermore, management has the responsibility
for selection, monitoring and support of the Study Director to ensure that studies are carried out in
compliance with the GLP Principles. Any minimal qualifications established by management for the position
of Study Director should be documented in the appropriate personnel records. In addition to a strong
technical background, the coordinating role of the Study Director requires an individual with strengths in
communication and problem solving and managerial skills.
Interface with the Study
The Study Director has the overall responsibility for the conduct of a study. The term
"responsibility for the overall conduct of the study and for its final report" may be interpreted in a broad sense
for those studies where the Study Director may be geographically remote from parts of the actual
experimental work. With multiple levels of management, study personnel and QA staff, it is critical that
there are clear lines of authority and communication, and assigned responsibilities, so that the Study Director
can effectively carry out his GLP responsibilities. This should be documented in writing. Test facility
management should ensure that for multi-site studies clear lines of communication exist between the Study
Director, Principal Investigator(s), the Quality Assurance Programme(s) and the study personnel
For studies that have delegated responsibilities to a PrincipalInvestigator(s), the Study Director will
rely on that individual to assure that relevant phase(s) of the study are conducted in accordance with the study
plan, relevant SOPs and with GLP Principles. The Principal Investigator should contact the Study Director
when event(s) occur that may affect the objectives defined in the study plan. All communications should be
documented.
Communication between the Study Director and QA is required at allstages of the study.
This communication may involve:
— an active involvement with QA, for example, review of study plans in a timely manner,
involvement in the review of new and revised Standard Operating Procedures, attendance of
QA personnelat study initiation meetings and in resolving potential problems related to GLP.
— responding to inspection and audit reports promptly, indicating corrective action and, if
necessary, liaising with QA staff and scientific and technicalpersonnelto facilitate responses to
inspection/audit findings.
Replacement ofthe Study Director
The Study Director has the responsibility for the overall conduct of a study according to the GLP
12. 12
Principles and he has to ascertain that in every phase of a study these principles are fully complied with, that
the study plan is followed faithfully and that all observations are fully documented. Theoretically, this
13. 13
responsibility can only be fulfilled if the Study Director is present all the time during the whole study. This is
not always feasible in practice and there willbe periods of absence which might make replacement necessary.
While the circumstances under which a Study Director would be replaced are not defined in the GLP
Principles, they should be addressed to the degree feasible by the facility’s SOPs. These SOPs should also
address the procedures and documentation necessary to replace a Study Director.
The decision for replacement or temporary delegation is the responsibility of management. All
such decisions should be documented in writing. There are two circumstances where replacement might be
considered, both of which are of importance only in longer-term studies, since the continuing presence of a
Study Director during a short study may be assumed. In the event of termination of employment of a Study
Director, the need for replacing this key person is obvious. In this case, one of the responsibilities of the
replacement Study Director is, with the assistance of Quality Assurance personnel, to assure himself as soon
aspracticable of the GLP compliance in the study asconducted to date. The replacement of a Study Director
and the reasons for it must be documented and authorised by management. It is also recommended that the
results of any interim GLP review should be documented in case deficiencies or deviations have been found.
The second circumstance is when a Study Director is temporarily absent because of holidays,
scientific meeting, illness or accident. An absence of short duration might not necessitate the formal
replacement of the Study Director if it is possible to communicate with him if problems or emergencies arise.
If critical study phases are expected to fall into the period of absence, they may either be moved to a more
suitable time (with study plan amendment, if necessary), or a replacement of the Study Director may be
considered, either by formally nominating a replacement Study Director or by temporary delegation of
responsibilities to competent staff for this specific phase of the study. Should the unavailability of the Study
Director be of longer duration, a replacement should be named rather than delegation to competent staff.
The returning Study Director must ascertain as soon as practicable whether or not deviations from
GLP Principles have occurred, irrespective of whether or not he was formally replaced during his absence.
Deviations from GLP Principles during his absence should be documented by the returning Study Director.
Legal Status of the Study Director
The Study Director, by virtue of his signature in the final report confirming compliance with the
GLP Principles, assumes responsibility for the performance of the study in compliance with GLP Principles
and for the accurate representation of the raw data in the final report. However, the legal liability of the
Study Director is established by national legislation and legal processes, and not by the OECD Principles of
GLP.