OECD Principles on Good Laboratory Practice

What the authority record establishes

OECD GLP principles organize test-facility management, quality assurance, facilities, apparatus, test systems, materials, procedures, study performance, reporting, and archives.

Implemented through national GLP programs and applicable requirements

The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.

Why it matters to this market

Scientific systems should preserve study responsibilities, test-system identity, methods, observations, changes, reports, and archives without conflating system capability with study validity.

Affected operating stages

• Study Planning
• Test-System Management
• Procedure Execution
• Observation
• Reporting
• Archive

Capabilities to examine

Sample Registration Identity And Lifecycle Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for sample registration identity and lifecycle management.

Aliquot Batch Container And Chain-Of-Custody Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for aliquot batch container and chain-of-custody management.

Instrument Asset Calibration And Maintenance Records

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for instrument asset calibration and maintenance records.

ELN Experiment Authoring And Collaboration

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for ELN experiment authoring and collaboration.

Protocol Method Template And Version Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for protocol method template and version management.

Electronic Signatures Audit Trails And Record History

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for electronic signatures audit trails and record history.

Role Identity Access And Segregation-Of-Duties Controls

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for role identity access and segregation-of-duties controls.

Deployment Administration Change Control And Validation Support

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for deployment administration change control and validation support.

Affected buyer audiences

• nonclinical laboratories
• study directors
• quality assurance
• sponsors
• inspectors

Implementation questions

• Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
• What is binding, what is guidance, and what is a technical or consensus standard?
• Which publication, adoption, effective, application, transition, and enforcement dates differ?
• Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
• How will a source revision affect open work and historical decisions?

Interpretation boundary

The principles do not validate software, determine a study's scientific validity, or establish GLP status for a facility or study.