Start with the regulatory scope
- Good Laboratory Practice
- Good Laboratory Practice, or GLP, is a quality system for nonclinical laboratory studies. In FDA's 21 CFR Part 58, the scope is nonclinical laboratory studies that support or are intended to support applications for FDA research or marketing permits. OECD describes GLP as a managerial quality-control system for how nonclinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived.1,2,3
- Good Manufacturing Practice
- Good Manufacturing Practice, often written as GMP or CGMP in FDA drug context, is a quality system for manufacturing and controlling products. FDA says drug CGMP regulations contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing drug products, and 21 CFR Part 210 frames those requirements around assuring identity, strength, quality, purity, and safety under the Federal Food, Drug, and Cosmetic Act.4,5
The simplest difference is the object being controlled. GLP controls the integrity of a defined nonclinical study and its records. GMP controls the production and quality system used to make, test, package, hold, and release regulated products or batches. A program can need both, but they answer different regulatory questions.1,2,4,5
How the systems assign responsibility
| Question | GLP answer | GMP answer |
|---|---|---|
| Primary object | A defined nonclinical study, its protocol, raw data, specimens, report, and archives | A manufacturing or quality system, product batch, facility, process, material, label, laboratory record, or release decision |
| Quality role | Testing facility management designates a study director and quality assurance unit for each study | The quality control unit has authority over components, drug product containers, closures, in-process materials, packaging, labeling, records, and release decisions |
| Core record | Protocol, protocol changes, raw data, final report, quality assurance statement, and retained records | Master production and control records, batch production and control records, laboratory records, stability records, and deviation investigations |
| Typical trigger | A nonclinical safety or related study intended for submission to a receiving authority | Manufacturing, processing, packing, holding, or distributing a regulated product under the applicable quality-system rule |
In FDA GLP, testing facility management designates the study director before the study begins, assures that a quality assurance unit exists, and assures that resources, personnel, facilities, equipment, materials, and methods are available as scheduled. The study director is the single point of study control for technical conduct, interpretation, analysis, documentation, and reporting.1
In FDA drug CGMP, the quality-control unit reviews and approves production and control records before batch release, while Part 211 also sets requirements for written production controls, in-process sampling, laboratory controls, master records, batch records, and investigations of unexplained discrepancies or specification failures.4,6
Where GLP usually matters
- FDA GLP applies to nonclinical laboratory studies that support or are intended to support applications for FDA research or marketing permits for regulated products, including drugs, medical devices, biological products, food and color additives, animal food additives, and electronic products.1
- OECD GLP covers nonclinical health and environmental safety studies for chemical products and related test items submitted to receiving authorities for registration, licensing, or regulation.2
- GLP records center on the approved protocol, direct and dated raw data entries, test and control article characterization, final report content, quality assurance statement, and archives.1
- OECD explicitly separates GLP nonclinical testing from studies that use human subjects, so GLP should not be confused with clinical-trial quality systems.2
Where GMP usually matters
For drugs, FDA says CGMP regulations are the minimum quality requirements for methods, facilities, and controls used in manufacturing, processing, and packing drug products. FDA also states that the marketing-application review includes assessing whether the manufacturer has the facilities, equipment, and ability to manufacture the drug it intends to market.4,5
- 21 CFR Part 210 identifies current good manufacturing practice requirements for drug manufacture, processing, packing, or holding, and points to detailed requirements in related parts such as Part 211.5
- 21 CFR Part 211 covers finished-pharmaceutical controls such as quality-control responsibilities, production and process controls, packaging and labeling controls, laboratory controls, master records, batch records, and laboratory records.6
- FDA's CGMP explanation cautions that finished-product testing alone is not enough to assure quality because batch testing usually samples only part of the batch, so quality must be built into the process.7
- For medical devices, FDA's QMSR became effective on February 2, 2026, amended device CGMP requirements in 21 CFR Part 820, and incorporates ISO 13485:2016 by reference, so device programs need the device quality-system frame rather than a drug-only CGMP shorthand.8
How to choose when both appear in one program
| Workstream | GLP question | GMP or QMS question |
|---|---|---|
| Nonclinical safety study | Is the study intended to support a research or marketing permit, and does it need GLP protocol, conduct, reporting, quality assurance, and archival controls? | Were the test article, control article, batch, container closure, or supplied materials made and documented under the applicable manufacturing-quality system? |
| Clinical or commercial drug batch | Is any testing part of a GLP nonclinical study, or is it development, release, stability, or comparability work outside GLP scope? | Are the manufacturing, release, laboratory, stability, packaging, labeling, and record controls aligned with drug CGMP requirements? |
| Medical device or accessory | Is a nonclinical safety study being generated for regulatory submission, and does the study need GLP controls? | Is the product a finished device or accessory subject to QMSR design, production, risk-management, record, and inspection expectations? |
| Method development or feasibility testing | Will the report be used as regulated nonclinical safety data, or only to select a method or design the later study? | Will the result support a controlled manufacturing, in-process, release, stability, or quality-system decision? |
What to define before requesting testing
- State the intended regulatory use of the result: exploratory development, GLP nonclinical study, GMP release or stability support, QMSR device evidence, or another defined quality decision.1,6,8
- Identify the test article, control article, product batch, manufacturing status, container closure, storage condition, acceptance criteria, method status, and target jurisdiction before study start.1,6
- Define responsible roles before samples move: sponsor, test facility, study director, and quality assurance unit for GLP; manufacturer and quality-control or quality-system owners for GMP or QMSR work.1,6,8
- Keep report claims separated. A report can document study conduct, test results, method details, and quality records, but it does not by itself certify a site, authorize a product, or convert one quality system into another.1,4,8