Good Laboratory Practice (GLP) is a quality system for nonclinical safety studies. “Current GLP” or cGLP appears in some search phrasing, but OECD and FDA frameworks use GLP and do not define a separate universal cGLP tier. GLP is distinct from routine pharmaceutical QC under GMP.
Key takeaways
- GLP protects the quality and integrity of nonclinical safety data submitted to regulators.
- OECD GLP supports international data acceptance through the Mutual Acceptance of Data (MAD) system.
- FDA’s 21 CFR Part 58 applies to specified nonclinical studies supporting FDA research or marketing permits.
- Routine commercial batch testing is generally a GMP activity, not automatically a GLP study.
What is GLP in pharmaceutical research?
GLP is a management system for planning, conducting, monitoring, recording, reporting and archiving nonclinical safety studies. OECD GLP principles apply to test facilities generating data for regulatory decisions, including some studies of pharmaceuticals, chemicals, pesticides and veterinary products.
In the United States, 21 CFR Part 58 covers specified nonclinical studies supporting FDA research or marketing permits for products such as drugs, biologics and devices. It excludes clinical studies involving people and basic exploratory studies of potential utility or physical and chemical characteristics. Not every experiment in a pharma laboratory is a GLP study.
Terminology note: The cited OECD and FDA frameworks use “GLP.” This article uses “cGLP” to match the search phrase, but readers should identify the applicable national GLP framework rather than assume a separate, harmonized “current GLP” standard.
GLP vs GMP: what is the difference?
| Area | GLP | GMP |
|---|---|---|
| Main purpose | Ensure the quality and integrity of nonclinical study data. | Control the manufacture, testing and release of medicines to required quality standards. |
| Typical example | Repeat-dose toxicity study of a new drug candidate in test systems. | Assay and release testing of a commercial tablet batch. |
| Study controls | Study protocol, Study Director, independent Quality Assurance Unit, raw data and archive. | Approved manufacturing procedures, batch records, laboratory controls and quality-unit oversight. |
| Regulatory reference | OECD Principles; U.S. 21 CFR Part 58; applicable national requirements. | Applicable regional GMP laws and guidance, such as U.S. drug cGMP regulations. |
Both systems require controlled work, but have different scopes. A GLP toxicology study may include drug-concentration analysis; a separate assay used to release a commercial batch is generally controlled under GMP.
Core principles of a GLP-compliant study
OECD GLP assigns responsibilities across test-facility management, the Study Director, study personnel and the Quality Assurance Unit (QAU). Practical controls commonly include:
- Defined roles: management appoints a qualified Study Director responsible for overall study conduct.
- Independent quality assurance: the QAU inspects study phases, reports findings and checks that records and reports match the study.
- Approved protocol and SOPs: methods, responsibilities and study changes are controlled and documented.
- Suitable facilities and equipment: test systems and instruments are appropriate, maintained and documented for the study.
- Reliable raw data: original observations are attributable, complete and recorded so the study can be reconstructed.
- Final report and archive: the report reflects the data, and protocols, records and specimens are retained as required.
For a toxicity study, the protocol defines doses and observations, staff record findings, the QAU inspects study phases, and the final report is checked against raw data before archiving. A practical development example is a repeat-dose toxicity study for a new oral candidate. Assigned staff record observations under controlled procedures, the Study Director oversees conduct, and the independent QAU inspects study phases. If an unexpected result occurs, its context and any correction are documented so the final report can be checked against underlying records. This supports a reviewable safety package rather than disconnected laboratory results.
OECD MAD and acceptance of GLP studies
The OECD Mutual Acceptance of Data (MAD) system supports reuse of qualifying safety-study data across participating countries. Studies must follow OECD Test Guidelines and GLP; the facility must be inspected and its national compliance-monitoring programme successfully evaluated by OECD.
For EFSA dossiers, studies generally need to come from compliant facilities in OECD or MAD-adherent countries and fall within the relevant scope. EFSA may accept some non-MAD studies under specified conditions, including inspection by an EU GLP authority. Sponsors should verify a facility’s status and expertise with the monitoring authority. This matters when preparing multi-country regulatory submissions.
Practical checks before submitting a GLP study
- Confirm the study and regulatory use fall within the applicable GLP framework.
- Verify facility compliance status for the relevant study area.
- Reconcile protocol, amendments, raw data, QAU statements and final report.
- Check that records are archived and retrievable.
- Define sponsor and facility responsibilities for outsourced work.
EFSA may request a study audit if a GLP concern arises. Under U.S. Part 58, FDA may refuse to consider a particular nonclinical study found non-compliant. Outcomes depend on the facts and applicable procedure.
Frequently asked questions about cGLP and GLP
1. What does cGLP mean?
It is commonly expanded as “current Good Laboratory Practice,” but the OECD and FDA frameworks cited here use the term GLP. It should not be assumed to mean a separate universal regulatory tier.
2. What is the purpose of GLP?
GLP helps ensure that nonclinical safety studies are planned, conducted, recorded, reported and archived in a controlled way so regulators can assess reliable data.
3. Does GLP apply to routine pharmaceutical QC testing?
Not automatically. Routine testing supporting manufacture or batch release is generally controlled under applicable GMP requirements. GLP applies when work is a regulated nonclinical study within the relevant framework.
4. What is the FDA GLP regulation?
FDA’s Good Laboratory Practice requirements for nonclinical laboratory studies are in 21 CFR Part 58.
5. Are GLP studies clinical trials?
No. FDA Part 58 excludes studies using human subjects and clinical studies. Clinical trials follow clinical-research requirements such as Good Clinical Practice.
6. What is the OECD MAD system?
It is an agreement that supports acceptance of qualifying nonclinical safety data among participating countries when studies follow OECD test and GLP standards.
7. Who checks GLP compliance at a test facility?
National GLP compliance-monitoring authorities inspect facilities and may audit studies within their programme’s scope.
8. What is the role of the Study Director?
The Study Director has overall responsibility for the technical conduct, interpretation, documentation and reporting of an individual GLP study.
9. What does the GLP Quality Assurance Unit do?
The QAU independently monitors study conduct and records against GLP requirements, documents inspections and communicates issues that may affect study integrity.
10. Can a regulator reject a non-compliant GLP study?
Regulatory consequences depend on the jurisdiction and circumstances. Under U.S. Part 58, FDA may refuse to consider a particular study found not to comply with GLP regulations.