GLP certification and how to check a laboratory's compliance
GLP certification means facility-level compliance under a national monitoring programme. Check laboratory status, study scope and the receiving regulator.
Good laboratory practice certification, usually called GLP certification, means a test facility has been inspected and found compliant under a national monitoring programme. It is not a universal OECD certificate or a guarantee that every study will be accepted, as the OECD framework makes clear.
For a sponsor choosing a laboratory, the task is to check what its compliance evidence actually covers. The UK issues a statement of GLP compliance, while Switzerland publishes a facility register. US FDA and EPA programmes have different regulatory scopes, as the comparison below explains. A document labelled "GLP certificate" needs to be read against the relevant authority's system.
What good laboratory practice compliance covers
GLP is a quality system for non-clinical health and environmental safety studies. It governs how studies are planned, performed, monitored, recorded, reported and archived. National authorities monitor compliance through facility inspections and study audits. These are the foundations of facility recognition described by the OECD.
Keep training separate. An individual's GLP course certificate does not establish the facility-level compliance recognised under OECD monitoring. When buying study work, ask for evidence about the facility, not just staff training.
The phrase "GLP compliant" also needs context. Which site does the evidence identify? Does it cover the relevant study activities? The Swiss register, for example, records inspection dates and areas of expertise. A name on a list is not permanent, unrestricted approval.
How GLP recognition differs by country
Use the authority's own terminology when checking a laboratory. The same request for a "GLP lab certification" can lead to different evidence in each system.
| System | Evidence to check | Limit to keep in mind |
|---|---|---|
| UK | Statement of GLP compliance and programme membership | Prospective membership is not full membership. |
| Switzerland | Public GLP register, inspection dates and areas of expertise | The register records compliance at the time of inspection. |
| US FDA | Nonclinical laboratory inspection information | This is inspection information, not a certification register. |
| US EPA | Evidence relevant to its GLP inspection and data-audit programme | Its regulatory scope does not cover all laboratory services. |
The UK MHRA guidance explains its membership and statement process. For Switzerland, consult the official facility register.
In the US, FDA inspects nonclinical laboratories for compliance with 21 CFR Part 58. EPA's monitoring programme covers pesticide-registration data under FIFRA and specified testing under TSCA. EPA identifies 40 CFR Part 160 for FIFRA and Part 792 for TSCA. Don't treat the two agencies as one programme.
How to check a GLP laboratory before commissioning work
These are practical buyer checks, not a universal legal checklist. Start with the study you need and the authority that will receive it.
Identify the relevant programme
Ask the laboratory which national authority monitors its GLP compliance. Then check that programme against the intended regulatory use. In the US, distinguish FDA-related nonclinical work from testing within EPA's stated scope.
Avoid accepting the phrase "internationally certified" without supporting details. Ask which authority and monitoring programme the laboratory means.
Match the facility and study activities
Check the facility name and site against the compliance evidence. Don't assume one site's status covers every location operated by the same business.
Compare the proposed work with the recorded activities or expertise. Switzerland's register supplies areas of expertise alongside inspection information. Use those details to assess whether the entry fits the work you plan to commission.
Request evidence and check current status
For a UK facility, request its statement of GLP compliance. The MHRA guidance says facilities should be able to supply it and links the membership list.
For a Swiss facility, check the register's inspection date. Contact the authority if current status is uncertain, as the register page advises. An old inspection entry alone cannot settle that question. Ask the laboratory to explain any mismatch between its supplied evidence and the authority's record. Resolve uncertainty before relying on the claimed status for your proposed work.
Dates need care. A register page's publication date and a facility's inspection date are different things. Read the facility record rather than judging status from the page heading.
Confirm the intended submission requirements
Ask whether the proposed study meets the receiving regulator's requirements. Facility recognition does not settle every question about study compliance or test methods.
The OECD Mutual Acceptance of Data decision concerns chemical test data generated in an OECD member country. The data must meet both OECD Test Guidelines and OECD GLP Principles. Acceptance is for assessment, not automatic product authorisation.
How a laboratory obtains GLP recognition
There is no single global application procedure. The UK provides a useful example, but its programme is open only to UK facilities.
Under the UK process, a facility applies to the UK GLP Monitoring Authority. Meeting the application requirements leads to prospective membership. An implementation inspection then examines quality systems, premises and available supporting records.
The facility must respond to findings with corrective actions. Once satisfied, the authority grants full membership and issues a statement of GLP compliance. Subsequent inspections examine systems, facilities, and completed and ongoing studies. Serious concerns can lead to membership suspension or disqualification of specified studies' GLP status.
In Switzerland, applications for register inclusion go to the Notification Authority for Chemicals. Use the Swiss authority's application instructions rather than assuming the UK procedure applies. The authority coordinates inspections and study audits with FOPH, FOEN and Swissmedic. Their responsibilities depend on the study properties, as the Swiss general guidance explains.
Does a GLP certificate guarantee international acceptance?
No. OECD mutual acceptance depends on specified conditions, not merely possession of a document called a certificate. The 1989 compliance decision provides for national monitoring, designated authorities and exchange of compliance information.
Check the receiving authority's requirements before relying on cross-border acceptance. Ask whether the particular study, methods and regulatory use meet those requirements. A laboratory's compliance document alone does not answer that question.
RegAffairs AI's answer on GLP certification explains facility recognition and Swiss GLP monitoring.