Good laboratory practice explained for regulatory teams
Good laboratory practice is a quality system for non-clinical safety studies, covering OECD principles, GLP vs GMP and GCP, and US, UK and Swiss rules.
Good laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. That wording is from the OECD principles.
The instrument was adopted in 1981, and the principles in Annex II are the 1997 revision. A 2019 amendment of the instrument is not a new edition of those principles. For a team commissioning safety data, GLP is about how the study was run and whether the records can be traced. Laboratory tidiness, or safe working on its own, does not meet the definition. The principles assign responsibilities to management, the study director and independent quality assurance personnel, and they set requirements for study plans, equipment, raw data and final reports. OECD GLP principles
What studies does GLP cover?
OECD GLP covers non-clinical safety testing of pharmaceuticals, pesticides, cosmetics, veterinary drugs, food and feed additives, and industrial chemicals. These studies can take place in laboratories, greenhouses or the field. The scope therefore extends beyond work inside a laboratory building. National legal exemptions can apply, so the principles do not make every research activity subject to GLP. OECD scope
Non-clinical does not mean non-pharmaceutical: pharmaceutical safety studies are expressly within the OECD scope. Studies using human subjects are excluded. That distinction separates GLP safety studies from the human-subject trials addressed by good clinical practice. OECD explanation
Before commissioning work, identify the receiving authority and the purpose of the study. Then check the applicable rules rather than treating GLP as one worldwide legal requirement. For example, FDA Part 58 defines its own scope, while EPA operates separate GLP programmes for pesticide and industrial-chemical data.
The ten areas in the OECD GLP principles
Readers searching for good laboratory practice guidelines should start with these principles, not a general laboratory-safety checklist. The requirements below come from Annex II of the OECD instrument.
Organisation and quality assurance
Test facility management must provide qualified personnel and define their responsibilities. Each study needs an appointed study director with responsibility for its conduct. The facility has to document those responsibilities. OECD organisation requirements
A documented quality assurance programme is a separate requirement. QA personnel must be independent of the study they assess. Their work includes inspections and a QA statement for the final report. A study team's own checks do not replace this independent role. OECD quality assurance requirements
Facilities, equipment and test systems
Premises must suit the work, with separation of activities where needed and suitable storage and archive areas. Equipment needs maintenance and calibration records. Computerised systems must be validated, and reagents must be identified. OECD facilities and apparatus requirements
Test systems form another area. Physical, chemical and biological systems need appropriate conditions, identification and records. Test and reference items have their own requirements for identity, characterisation, handling, storage and stability information. Do not confuse the item being tested with the system used to test it. OECD test-system and test-item requirements
Procedures and study performance
Written standard operating procedures must have management approval, and current versions must be available to staff. Deviations need documentation. Each study also needs a written plan approved by the study director before initiation. The study record must preserve traceable data and distinguish plan amendments from deviations during the work. OECD SOP and study-performance requirements
For a buyer, asking whether a laboratory "has SOPs" is only a starting point. Ask how staff access the approved versions and how the study director handles changes. OECD principles
Reporting and archives
The final report must be signed and dated, with compliance and QA statements. Later amendments must remain controlled. Archives need indexing, authorised access and records of material movements. Retention depends on applicable requirements. The OECD principles do not supply one universal retention period for every study. OECD reporting and storage requirements
GLP vs GMP vs GCP
The distinction is the activity each regime principally governs. But the name on the laboratory door does not decide which regime applies.
| Regime | Principal focus |
|---|---|
| GLP: good laboratory practice | Organisation and conduct of non-clinical health and environmental safety studies. OECD |
| GMP: good manufacturing practice | Minimum standards a medicines manufacturer must meet in its production processes, including consistent quality and suitability for intended use. EMA |
| GCP: good clinical practice | International ethical and scientific quality standard for designing, recording and reporting human-subject trials, protecting participants and supporting credible data. EMA |
This comparison describes the main focus, not exclusive organisational boundaries. GMP does not exclude quality-control testing, and GCP does not mean that laboratories have no role. EMA GMP guidance and GCP guidance
Good laboratory practice regulations and monitoring
United States
FDA's 21 CFR Part 58 applies to nonclinical laboratory studies that support, or are intended to support, applications for research or marketing permits for FDA-regulated products. Its scope includes human and animal drugs, food and color additives, animal food additives, human medical devices, biological products and electronic products. FDA sections 58.1 and 58.3
The FDA definition excludes human-subject studies, clinical studies or field trials in animals, and specified basic exploratory studies. Those exclusions belong to that FDA definition. Do not transfer them to the OECD framework, which expressly allows field studies within its scope. FDA definitions and OECD scope
EPA has separate GLP regulations for pesticide and industrial-chemical regulatory data. Its compliance monitoring includes facility inspections and study data audits. Checking FDA Part 58 alone will not resolve an EPA study's requirements. EPA compliance monitoring programme
United Kingdom
For good laboratory practice in the UK, MHRA guidance says facilities conducting the listed regulatory safety studies must comply with GLP and join the compliance monitoring programme. The sectors include pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives, and biocides. Programme membership is open only to UK facilities.
Admission involves an application, an implementation inspection and satisfactory responses before full membership and a compliance statement. A staff training certificate doesn't establish programme membership. For a UK provider, ask about its facility-level monitoring status. MHRA membership process
Switzerland
Swiss GLP is based on OECD principles under the GLP ordinance, OGLP, SR 813.112.1. Monitoring responsibilities are shared by FOPH, FOEN and Swissmedic. Swiss notification authority
The Swiss register lists facilities found compliant at the time inspected and included in the authorities' monitoring programme. It describes routine reinspection every two to three years. That interval is Swiss guidance, not a universal GLP inspection schedule. Register inclusion does not establish perpetual compliance or acceptance of every study. Check the current entry and relevant study categories. Swiss GLP test-facility register
GLP study provider checklist
Use these questions when assessing a provider. They are a procurement checklist derived from the principles, not a complete statutory checklist or guarantee of acceptance. GLP compliance does not, by itself, choose the test method or secure product approval. OECD principles
- What monitoring status and study scope cover the proposed work?
- Who is the study director, and how are responsibilities documented?
- How does independent QA inspect the study and report its findings?
- When will the study plan be approved, and how will changes be recorded?
- How can raw data be traced into the final report?
- Where will records be archived, and which retention requirements will apply?
Request supporting documents rather than relying on a general claim of "GLP certification." For Swiss providers, compare the proposed work with the official register entry and its study categories. OECD documentation requirements and Swiss register
RegAffairs AI provides a source-linked answer to "What is good laboratory practice?".