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| title | chunk | source | category | tags | date_saved | instance |
|---|---|---|---|---|---|---|
| Good laboratory practice | 3/4 | https://en.wikipedia.org/wiki/Good_laboratory_practice | reference | science, encyclopedia | 2026-05-05T09:03:28.428083+00:00 | kb-cron |
== European Union == Source: The Principles of GLP help ensure the quality and accuracy of data in chemical testing, and help prevent scientific fraud, as adopted by the European Union (EU). European GLP Regulations and Directives also apply to European Economic Area (EEA) member states which include Iceland, Liechtenstein, and Norway. GLP principles govern the laboratory safety testing of substances in various products, mandated by product-specific legislation in the EU/EEA. Directive 2004/9/EC mandates EU/EEA countries to designate GLP inspection authorities and includes requirements for reporting and mutual acceptance of data within the internal market. Annex I of the Directive incorporates OECD Revised Guides for Compliance Monitoring Procedures for GLP, along with OECD Guidance for the Conduct of Test Facility Inspections and Study Audits. It ensures compliance with these guidelines during laboratory inspections and study audits. This directive replaced Directive 88/320/EEC as of 11 March 2004. Directive 2004/10/EC, the second core EU GLP Directive, harmonizes laws and administrative provisions for applying GLP principles and verifying their implementation in chemical substance tests. It includes GLP principles in Annex I and requires EU/EEA countries to ensure that laboratories conducting safety studies on chemical products comply with OECD GLP principles. It replaces Directive 87/18/EEC. The Clinical Trials Facilitation Group (CTFG) of the Heads of Medicines Agency issued a Q&A document in 2017 addressing Good Laboratory Practice (GLP) requirements within the context of clinical trials for human medicines. This document aims to provide clarification and guidance on GLP principles applicable to non-clinical safety studies conducted as part of clinical trial applications. In March 2024, the Clinical Trials Coordination Group (CTCG) of the Heads of Medicines Agencies released a new recommendation paper on the principles of Good Laboratory Practices (GLP) for clinical trial applications governed by the EU Clinical Trials Regulation (Regulation (EU) No 536/2014). This paper was developed in collaboration with relevant groups from the European Medicines Agency (EMA) and the European Commission (EC) to clarify the applicable regulatory requirements and ensure transparency regarding the level of information required about GLP status in Clinical Trial Applications. This will assist researchers and sponsors in understanding what is expected and how to include the necessary information to support their applications. GLP supports the sharing of test data between countries, which helps avoid repeated testing, benefits animal welfare, and saves money for businesses and governments. Having common GLP standards also makes it easier to share information and prevents trade barriers, while helping to protect human health and the environment. The EU has established Mutual Recognition Agreements for GLP with Israel, Japan, and Switzerland.
== Key role for the Organisation for Economic Cooperation and Development == Source: USA's new GLP rule was adopted into the new toxicity test methods (called the Test Guidelines, TG) that the OECD created. The OECD Principles of Good Laboratory Practice (GLP) cover the testing of chemicals or chemical products in non-clinical settings, either in laboratory conditions or environmental settings, such as greenhouses and field experiments. These principles exclude studies involving human subjects. Depending on the location or governing rules in an OECD-member country, the OECD Principles of GLP might also extend to non-clinical safety testing of other regulated items, like medical devices. Examples studies conducted under GLP in OECD-member countries include:
Physical-chemical testing; Toxicity studies; Mutagenicity studies; Environmental toxicity studies on aquatic and terrestrial organisms; Studies on behavior in water, soil, and air; bioaccumulation; Studies to determine pesticide residues in food or animal feedstuffs; Studies on effects on mesocosms and natural ecosystems; Analytical and clinical chemistry testing. Safety testing data must be submitted to regulatory authorities for product marketing authorization. During the review process, the submitted data undergoes verification to ensure compliance with GLP standards. Additionally, the GLP compliance status of the testing facility where the study was conducted is assessed by referring to inspection information from national GLP compliance monitoring programs. OECD member countries where non-clinical health and environmental safety testing follows the OECD Principles of Good Laboratory Practice (GLP) have established national GLP Compliance Monitoring Programs (CMP) responsible for overseeing GLP compliance of test facilities within their jurisdictions. These CMPs verify GLP compliance through inspections of test facilities and audits of GLP studies. Test facilities that undergo periodic inspections by a CMP and are found to operate in accordance with GLP principles are recognized as GLP compliant. In OECD-member countries, testing facilities seeking recognition as GLP compliant can apply to the national CMP. The CMP then conducts inspections to assess if the test facility adheres to the OECD Principles of GLP. In other countries, CMPs have the authority to inspect any test facility that claims to conduct studies according to GLP standards.