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Good laboratory practice (GLP) is a standardised way of planning, performing and reporting laboratory-based studies to ensure a high standard of quality and reliability. Good Laboratory Practice (GLP) principles refers to a set of quality and validity standards for the organisation and management of test facilities and the data they produce. GLPGood laboratory practice (GLP) is a standardised way of planning, performing and reporting laboratory-based studies to ensure a high standard of quality and reliability guides the conduct and reporting of non-clinical studies supporting food and feed chain applications that EFSA evaluates. The principles of GLP were elaborated by the Organisation for Economic Cooperation and Development (OECD) and incorporated into EU law through the GLP directives, together with the OECD Guides on GLP and Compliance Monitoring Procedures. See the European Commission website for more information. The requirements for the application of GLP principles are laid down by a variety of different sectoral legal acts falling within EFSA’s remit and reflected in the corresponding EFSA guidance documents.

See the Applications section for the food sector areas. EFSA accepts GLP studies that are performed in GLP compliant test facilities located in an OECD member country or in a non-member country that adhere to the Mutual Acceptance of Data (MAD) system. The OECD website provides a list of OECD members and MAD-adherent countries. To find out whether a test facility is GLP compliant (e.g. for the relevant area of expertise), you should consult the respective GLP monitoring authoritybody established within an EU Member State or an OECD or Mutual Acceptance of Data (MAD)-adherent country with responsibility for monitoring the GLP compliance of test facilities within its territories. The European Commission provides information on test facilities inspected by EU GLP monitoring authorities. If the test facility is located outside the EU, links to national websites on GLP are available on the OECD website. We may accept studies that are conducted in a test facility located in a non-MAD adherent country under certain conditions, e.g. when the test facility has been inspected by an EU GLP monitoring authority and found to be GLP compliant for the respective area of expertise.

Information on the GLP status of such a test facility can be obtained from the respective EU GLP monitoring authority. Links to EU GLP monitoring authority contact points. EFSA can ask a GLP monitoring authority to carry out a GLP study audit to verify the GLP status of submitted studies under the relevant procedure. This may be either in the context of EFSA’s annual audit programme, or on ad hoc basis when we identify specific GLP-related concerns. There is an EFSA Working Group on Good Laboratory Practice, which contributes to our GLP activities and provides advice on specific GLP issues that may come up during the completeness/suitability check or risk assessmentA specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and MedicGLP Product risk characterisation of an application. For the meeting minutes and information on WG members see here. External Scientific Report for refining the methodology on the verification of GLP studies submitted within an application for regulated products. This report is the outcome of an EFSA Grant on the establishment of a GLP verification checklist for verifying GLP studies. Training material on the use of this checklist is made available on the EU academy platform.

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