Good Laboratory Practice
Good Laboratory Practice (GLP) principles are vital for ensuring the quality, reliability, and integrity of data produced during chemical testing, crucial for both regulatory compliance and scientific research.
Developed in collaboration with the Organisation for Economic Cooperation and Development (OECD), the GLP principles have been embraced by the European Union through the adoption of these standards and corresponding OECD guides into its GLP Directives. These principles facilitate the mutual acceptance of test data across countries, significantly reducing redundant testing, benefiting animal welfare, lowering costs for industries and governments, and aiding in the protection of human health and the environment. Read more on GLP on the OECD Good Laboratory Practice webpage.
Following Decision C (97)186/Final of the OECD Council, the EU has also established Mutual Recognition Agreements for GLP with several countries outside the EU, including Israel, Japan, and Switzerland, extending the applicability of these principles and ensuring the smooth exchange of test data. These agreements, coupled with OECD's broader framework, mean that data generated in compliance with OECD GLP guidelines are accepted among all OECD member countries as well as some non-member countries that adhere to the OECD's mutual acceptance of data (MAD) policy.
The application of GLP is mandated across a wide spectrum of non-clinical safety testing for various products, underlying the importance of these practices in maintaining high standards of testing integrity and safety evaluation. European Directives specifically outline the responsibilities of EU member states in designating authorities for GLP inspections, ensuring compliance, and facilitating the mutual recognition of test data within the internal market.
Implementation of the GLP Directives in the European states
In essence, GLP standards are a cornerstone for scientific testing in the chemical industry, supporting international collaboration, enhancing trade, and safeguarding public and environmental health.
Practical implementation:
Contact point:
Developed in collaboration with the Organisation for Economic Cooperation and Development (OECD), the GLP principles have been embraced by the European Union through the adoption of these standards and corresponding OECD guides into its GLP Directives. These principles facilitate the mutual acceptance of test data across countries, significantly reducing redundant testing, benefiting animal welfare, lowering costs for industries and governments, and aiding in the protection of human health and the environment. Read more on GLP on the OECD Good Laboratory Practice webpage.
Following Decision C (97)186/Final of the OECD Council, the EU has also established Mutual Recognition Agreements for GLP with several countries outside the EU, including Israel, Japan, and Switzerland, extending the applicability of these principles and ensuring the smooth exchange of test data. These agreements, coupled with OECD's broader framework, mean that data generated in compliance with OECD GLP guidelines are accepted among all OECD member countries as well as some non-member countries that adhere to the OECD's mutual acceptance of data (MAD) policy.
The application of GLP is mandated across a wide spectrum of non-clinical safety testing for various products, underlying the importance of these practices in maintaining high standards of testing integrity and safety evaluation. European Directives specifically outline the responsibilities of EU member states in designating authorities for GLP inspections, ensuring compliance, and facilitating the mutual recognition of test data within the internal market.
- Directive 2004/9/EC lays down the obligation of EU countries to designate the authorities responsible for GLP inspections in their territory. It also comprises reporting and internal market (mutual acceptance of data) requirements. The Directive requires that the OECD Revised Guides for Compliance Monitoring Procedures for GLP, as well as the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits, be followed during laboratory inspections and study audits. Directive 2004/9/EC has replaced Directive 88/320/EEC as of 11 March 2004.
- Directive 2004/10/EC requires EU countries to take all measures necessary to ensure that laboratories carrying out safety studies on chemical products comply with the OECD Principles of Good Laboratory Practice. Directive 2004/10/EC replaces Directive 87/18/EEC.
Implementation of the GLP Directives in the European states
In essence, GLP standards are a cornerstone for scientific testing in the chemical industry, supporting international collaboration, enhancing trade, and safeguarding public and environmental health.
Practical implementation:
Contact point:
