Good Laboratory Practice (GLP) provides a quality framework for applicable nonclinical safety studies. Good Laboratory Practice connects study planning and execution with defined responsibilities, quality assurance, reliable records, reporting, and archiving.

GLP does not automatically apply to every laboratory activity. Before establishing controls, determine the purpose of the study, its intended regulatory use, and the requirements of the relevant jurisdiction.

This guide explains the FDA and OECD GLP frameworks and practical considerations for personnel, procedures, equipment, study oversight, data integrity, and record retention.

This guide explains the FDA and OECD Good Laboratory Practice frameworks and practical considerations for personnel, procedures, equipment, study oversight, data integrity, and record retention. Understanding Good Laboratory Practice is essential for compliance.

What Is Good Laboratory Practice (GLP)?

Good Laboratory Practice is a quality system covering how applicable nonclinical health and environmental safety studies are organized, planned, conducted, monitored, documented, reported, and archived. Good Laboratory Practice supports confidence in the reliability and traceability of study data.

The OECD Principles of GLP address responsibilities, facilities, equipment, procedures, raw data, study reports, and record archiving. These controls help reviewers reconstruct what happened during a study and evaluate its results.

Why Is Good Laboratory Practice Important?

Nonclinical safety studies can inform important decisions about a product’s development and potential risks. Missing source records, unsuitable equipment, or undocumented changes can make the results difficult to interpret and undermine confidence in the study.

To adhere to Good Laboratory Practice, nonclinical safety studies can inform important decisions about a product’s development and potential risks.

For example, if a laboratory discovers that a balance was outside its acceptance limits, the team needs to identify which measurements and studies may have been affected. Equipment history, study records, and a documented assessment help establish the potential impact.

• Define responsibility for study activities and oversight.
• Support consistent execution of approved methods.
• Maintain traceability of test materials, equipment, and observations.
• Identify and evaluate departures from planned activities.
• Preserve evidence supporting study results and conclusions.
• Keep records accessible for review and reconstruction.

What Is the Difference Between GLP, GMP, and GCP?

GLP, GMP, and GCP address different regulated activities. Identify the purpose of the work and the applicable requirements before deciding which framework governs it.

• Good Laboratory Practice (GLP): Focuses on the organization, conduct, documentation, and reporting of applicable nonclinical safety studies.
• Good Manufacturing Practice (GMP): Focuses on manufacturing controls and product quality, including relevant quality-control laboratory activities.
• Good Clinical Practice (GCP): Focuses on protecting clinical trial participants and supporting reliable clinical trial results.

A laboratory’s name alone does not determine which requirements apply. Different activities within the same organization may fall under different frameworks, so responsibilities, procedures, and records should reflect the work being performed.

Define GLP Study Responsibilities

Clearly defined Good Laboratory Practice responsibilities help prevent gaps in study oversight. Good Laboratory Practice ensures that all aspects of the study are covered.

Clear responsibilities help prevent gaps in study oversight. Define who manages resources, directs the study, performs assigned activities, provides independent quality assurance, and maintains archived records.

Testing Facility Management

Management establishes the organizational support needed for study activities. This includes providing suitable personnel, facilities, equipment, procedures, and quality assurance arrangements under the applicable GLP framework.

Study Director

The Study Director provides overall study control and oversight. Responsibilities include directing study conduct, evaluating relevant departures from the plan, and ensuring that the report and retained records accurately represent the work.

Quality Assurance Personnel

Quality assurance provides independent monitoring of compliance with the applicable GLP framework. Define its reporting arrangements and separation from the study activities being monitored. Quality assurance oversight complements the Study Director’s responsibilities rather than replacing them.

Use Controlled Study Plans and Laboratory SOPs

A study plan or protocol describes the study’s objectives and planned methods. Standard Operating Procedures (SOPs) define established laboratory activities. Keep both controlled and accessible so personnel can identify which instructions apply to their work.

Prepare Before Study Activities Begin

Confirm that the relevant plan, procedures, personnel, equipment, and materials are ready before starting affected activities. Identify required records and clarify responsibilities for documenting observations and reporting unexpected events.

Distinguish Planned Changes from Deviations

Manage intended changes to the study plan through the applicable amendment process. When actual conduct departs from the approved instructions, document what happened and assess its effect on the study. Do not retrospectively rewrite instructions to conceal a departure.

Maintain Equipment Suitable for GLP Study Activities

Equipment performance can affect dosing, sample preparation, storage conditions, and analytical results. Establish maintenance, calibration, and performance checks appropriate to the equipment’s intended use and applicable requirements.

Identify Equipment and Track Its Status

Assign equipment identifiers and maintain relevant service, calibration, and performance records. Make its status clear to users and define how equipment is restricted when it is unsuitable for use.

Assess Failures for Study Impact

If equipment fails a check or is found outside acceptance limits, evaluate its previous use and identify potentially affected data and studies. Repairing or recalibrating the equipment addresses its current condition, but does not by itself resolve questions about earlier results.

Control Test Articles and Study Materials

Reliable study interpretation depends on knowing which materials were used and how they were handled according to Good Laboratory Practice. Establish identification, receipt, storage, preparation, and use controls appropriate to the study and applicable GLP framework.

Maintain Identification and Traceability

Record relevant material identifiers, batch or lot numbers, receipt details, storage conditions, and study use. Check that labels and preparation records allow personnel to distinguish materials and connect them to the correct study.

Evaluate Storage and Handling Problems

If a temperature excursion, labeling discrepancy, or preparation error occurs, identify the affected material and assess its suitability before further use. Document the evidence, potential study impact, and resulting decision.

Preserve GLP Raw Data and Study Traceability

Good Laboratory Practice emphasizes the importance of preserving raw data and study traceability to ensure accurate results.

Study records should allow reviewers to understand what was performed, who performed it, and how the reported results were obtained. Identify the source data and supporting information needed to reconstruct each activity.

Record Observations and Changes Transparently

Record observations promptly using the approved method. Preserve original entries when making corrections, and identify who made the change, when it was made, and the reason where required. Handle missing information through a documented process rather than inventing or backdating entries.

Retain the Information Behind Reported Results

A summary report may not contain all the information needed to evaluate an analysis. Determine which source records, calculations, methods, metadata, and relevant change histories must be preserved. Maintain links between those records and the reported results.

Review Final Study Reports and Archive Supporting Records

The final report should accurately represent the study’s methods, results, limitations, and conclusions. Review it against supporting records so discrepancies can be evaluated before finalization.

Resolve Differences Between the Report and Source Data

Check that reported values, calculations, and conclusions can be traced to retained evidence. Evaluate unexplained differences and describe relevant departures from planned activities. Follow the applicable process for report approval and subsequent corrections.

Plan for Retention and Retrieval

Identify the records and materials to be archived, their retention requirements, and the person responsible for their custody. Control access, storage, transfer, and authorized disposal. Check that paper and electronic records remain readable and retrievable throughout retention.

GLP Study Quality Checklist

Use this practical checklist to review study readiness and supporting controls. Adapt it to the applicable GLP framework, study type, and testing facility procedures.

• Are study responsibilities clearly assigned?
• Are personnel qualified for their tasks?
• Are applicable protocols and SOPs approved and accessible?
• Is equipment suitable, with its status and history documented?
• Are test materials identified and traceable?
• Are storage and handling conditions controlled?
• Are observations recorded promptly and corrections traceable?
• Are deviations documented and assessed for study impact?
• Is quality assurance appropriately independent?
• Can reported results be traced to supporting data?
• Are final reports reviewed and approved appropriately in accordance with Good Laboratory Practice?
• Are archived records protected and retrievable?

Frequently Asked Questions About Good Laboratory Practice

What Are the Benefits of Good Laboratory Practice?

Does GLP Apply to Every Laboratory?

No. Applicability depends on the study’s purpose, intended regulatory use, and relevant jurisdiction. Routine manufacturing quality-control testing should not automatically be classified as GLP simply because it takes place in a laboratory.

What Is the Difference Between a Protocol Amendment and a Deviation?

An amendment documents an intended change to the study plan through the appropriate approval process. A deviation documents a departure during study conduct and requires evaluation of its potential impact. An amendment should not be used to conceal an earlier departure.

Does an Electronic Quality Management System Guarantee GLP Compliance?

No. Software can support controlled procedures, training, equipment records, investigations, and audits. Compliance also depends on qualified personnel, appropriate oversight, proper study execution, reliable data, and effective operational controls.

Strengthen Your GLP Study Controls

Strengthening your Good Laboratory Practice controls can lead to better study outcomes and regulatory compliance.

Effective Good Laboratory Practice connects study planning with qualified personnel, suitable equipment, controlled procedures, independent quality assurance, and reliable records. These controls should support the study throughout its lifecycle.

Start by tracing one reported result back to its source records. Can your team identify the methods, equipment, materials, personnel, and relevant deviations involved? Use any gaps to improve traceability and oversight.

Contact Qualcy to discuss your organization’s needs for managing laboratory quality processes, including controlled procedures, training, equipment records, investigations, and audits in line with Good Laboratory Practice.

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