GLP vs. GLP-like in MedTech Studies | Practical Guide

GLP or not? This question arises in nearly every preclinical MedTech project. Misclassifying the role of Good Laboratory Practice (GLP) can lead to either unnecessarily high study costs or data that may not withstand regulatory review. Especially in the medical technology sector, a clear decision-making framework is often lacking, as GLP practices were originally designed for pharmaceutical and chemical safety studies. While they can be applied to medical devices, this is not mandatory in every scenario.

This article distinguishes between key GLP-related terms, classifies typical project scenarios from a regulatory perspective, and provides an operational checklist to help study sponsors and internal regulatory/QA teams make the right decision. All information is intended for general professional guidance and does not replace project-specific consulting or legal assessment in individual cases.

Distinguishing the key terms: GLP practices, GMP/QSR, QMSR and “GLP-like”

GLP (OECD Principles): What It Really Means

Good Laboratory Practice (GLP) is a quality system for non-clinical safety studies, defined by the OECD (Organization for Economic Co-operation and Development) principles and, in the U.S., by 21 CFR Part 58. Historically, GLP emerged as a direct response to data manipulation in the 1970s, including the IBT scandal (Industrial Bio-Test Laboratories), in which raw data in safety studies was falsified. The system ensures that studies are not only scientifically sound but also documented completely and protected against manipulation. The GLP principles provide guidelines on how studies must be planned, conducted, monitored, recorded, reported and archived. Key elements include a designated Study Director, an independent Quality Assurance Unit (QAU), complete raw data documentation and the possibility of regulatory GLP inspections at the testing facility.

Crucially: Good Laboratory Practice (GLP) is not a scientific but an organizational quality system. It ensures that studies are documented in a traceable, reproducible and integrity-assured manner.

GMP/QSR/QMSR: When are they relevant for MedTech?

Good Manufacturing Practice (GMP) and the FDA (U.S. Food and Drug Administration) Quality System Regulation (QSR, 21 CFR 820) govern the manufacturing and product quality of medical devices. The Quality Management System Regulation (QMSR) aligns the U.S. requirements in 21 CFR Part 820 more closely with ISO 13485:2016. These systems primarily concern manufacturing, not the conduct of preclinical safety studies.

GMP requirements apply only indirectly to preclinical studies, for example in the manufacture of test articles. Regulatory authorities require evidence that the test article or test sample was manufactured under controlled conditions that represent the subsequent production batch. An insufficient link between investigational product manufacturing, characterization and testing strategy can lead to inquiries, additional requests or limited usability of data.

“GLP-like”: Definition, Regulatory Positioning, Risks

“GLP-like” is not an official legal term and is not defined in any regulation. The term describes studies that apply selected GLP principles, such as SOPs (Standard Operating Procedures), data integrity requirements and documented deviations, without achieving full GLP compliance. The key risk: regulatory authorities do not automatically recognize GLP-like studies as equivalent.

A study declared “GLP-like” may be classified as insufficient during a regulatory review by the FDA or in the context of the MDR if crucial structural elements are missing. Sponsors choosing a GLP-like approach must therefore transparently define which GLP elements are implemented and which are intentionally omitted. The following table summarizes the key differences between the terms.

Terminology Matrix: GLP vs. GLP-like vs. GMP/QSR vs. QMSR

Legal basis	GLP: 21 CFR 58 / OECD GLP-like: none, internally defined GMP / QSR: 21 CFR 820 / EU MDR QMSR: 21 CFR 820 (revised)
Primary focus	GLP: data integrity and traceability GLP-like: scientific quality within an internally defined framework GMP / QSR: manufacturing process and product quality QMSR: harmonization with ISO 13485
QA structure required	GLP: yes, with QAU and Study Director GLP-like: recommended and to be documented project-specifically GMP / QSR: yes, through the quality management system QMSR: yes, aligned with ISO 13485
Archiving	GLP: required and regulated GLP-like: recommended, but clearly defined GMP / QSR: required as part of the product file QMSR: required
Regulatory usability	GLP: yes, as a formal evidence framework GLP-like: not automatic, depending on purpose and implementation GMP / QSR: yes, related to manufacturing and product quality QMSR: yes, related to manufacturing and quality management
Cost indicator	GLP: high GLP-like: medium GMP / QSR: context-dependent QMSR: context-dependent

When is GLP relevant — and when is GLP-like sufficient?

Regulatory scenarios requiring GLP

For nonclinical safety studies supporting IDE or PMA submissions, GLP is typically the reference framework; deviations must be transparently identified and justified. Whether GLP is required depends on the submission type, study design and the regulatory use of the data. GLP is particularly relevant for nonclinical safety studies intended to support FDA submissions, especially in the context of IDE (Investigational Device Exemption) and PMA (Premarket Approval).

For other submission types and in the MDR context, the required study quality should be assessed on a project-specific basis based on the purpose, endpoints and regulatory use of the data. In these cases, the regulatory authority expects a GLP-compliant test facility with a comprehensive quality assurance structure, traceable archiving and study materials ready for inspection. Deviations from GLP requirements must be documented in the final report in accordance with 21 CFR 58 Subpart J and evaluated for their impact on data integrity.

Special attention should be given to combination products. For combination products, additional toxicological and quality assurance requirements may apply. Their scope should be determined based on the specific regulatory pathway and the function of the drug component.

Typical GLP-like scenarios in everyday MedTech practice

GLP-like approaches are useful in situations where agility and scientific exploration are the primary focus. Typical scenarios in everyday MedTech practice are:

• Exploration phase and screening, such as early material selection or prototype comparisons
• Proof-of-concept without toxicological endpoints
• Internal pilot studies to validate animal models or surgical techniques
• Exploratory efficacy studies, provided they do not serve as primary safety evidence

In all these situations, full GLP compliance is often not required, provided that the data is not intended to serve as a key regulatory safety basis.

A common gray area involves pre-submission studies whose data are initially intended for internal use only but are later incorporated into a submission. Early communication with regulatory authorities via an FDA Pre-Submission Meeting or a Q-Submission inquiry is often the most appropriate route here. Audit readiness does not begin with the GLP study itself, but rather with strategic study planning. Those who skip this step risk one of the most costly experiences in preclinical development: having to repeat the study.

GLP-like as a minimum standard: The essential structural elements

Data integrity, SOPs, QA, raw data, archiving, deviations/CAPA

Even without formal GLP compliance, preclinical studies must meet a clear minimum standard: data integrity according to the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available), binding SOPs for core processes, a documented deviation management process with CAPA logic (Corrective and Preventive Action), and an archiving system that enables subsequent study reconstruction. Those who consistently implement these structural elements support audit readiness, even without the formal overhead of a fully GLP-compliant testing facility.

Graphic: “GLP-like Core Elements: 10-Point Checklist”

Alternative: PDF for download

The Cost-Time Leverage: Clarifying issues early on saves you from having to repeat studies

The wrong choice between GLP and GLP-like can quickly cost twice as much: both financially and in terms of time. Depending on the study design, QA structure and documentation requirements, GLP studies often incur a significant additional cost. This extra cost is an insurance policy: in long-term implant studies, a data set that is not usable for regulatory purposes can result in substantial additional costs running into the high six-figure range.

A typical scenario from project practice: A sponsor conducts a preclinical study under GLP-like conditions, later determines that the collected data is indeed needed for regulatory submission and must verify whether it is sufficiently usable for regulatory purposes. Otherwise, a repeat study under full GLP compliance may be required. In practice, the time required for early, structured project scoping can usually be completed in a short period. A repeated study, on the other hand, entails significant additional costs, months of delay in the development process and, as a result, often a later market launch.

The key rule is: The earlier the regulatory strategy is established, the lower the subsequent adjustment effort. Backward planning from the target regulatory milestone is crucial here: biological processes such as in-vivo phases or histopathology cannot be shortened. Those who integrate GLP practice requirements early into study planning ensure audit readiness from the start. Those who thoroughly clarify before the study begins whether full GLP practices or GLP-like standards are appropriate avoid duplication of effort and costly rework. Especially for novel devices, combination products or products on the borderline between Class IIb and III, early communication with regulatory authorities is an effective tool for risk reduction.

Checklist for Study Sponsors: “Ready for GLP / Regulatory”

Before commissioning a preclinical study, every study sponsor should have systematically clarified the following points. This checklist outlines the minimum requirements for strategic preparation, regardless of whether the study is to be conducted under GLP or GLP-like conditions:

• Regulatory pathway defined (510(k), PMA, IDE, MDR class)?
• Are study data intended for regulatory submission — yes or no?
• GLP-compliant test facility identified and qualification or audit requirements assessed?
• Test article fully characterized (batch documentation, sterility, shelf life)?
• SOPs, study protocol and deviation management documented?
• QA structure established (for GLP: QAU / for GLP-like: risk-based or sample-based QA checks)?
• Data integrity and archiving concept agreed upon?
• Has early communication with regulatory authorities (Pre-Sub / Q-Sub) been reviewed and, if necessary, initiated?

FAQ: GLP Practices in the MedTech Sector

What is the legal distinction between GLP and GLP-like?

GLP is based on binding legal frameworks such as the OECD Principles, 21 CFR Part 58 and EU Directive 2004/10/EC. “GLP-like,” on the other hand, is not a term defined by regulations. GLP-like studies are not automatically considered equivalent to GLP-compliant studies under regulatory guidelines; their acceptability depends on the purpose of the data and the specific design of the study. The responsibility for correct classification and documentation lies with the study sponsor.

Does the FDA accept GLP-like studies?

Not across the board. For nonclinical safety data from formal laboratory studies, the FDA may — depending on the type of submission, the purpose of the data and the study design — expect GLP compliance under 21 CFR Part 58. Exploratory studies not intended for regulatory submission are not subject to GLP requirements. In case of doubt, a pre-submission meeting clarifies the specific requirements.

How much more expensive is a GLP study than a GLP-like study?

Based on experience, the 20–40% premium is due to the QA structure, archiving, the study director role and the testing facility’s readiness for inspection. The overall cost analysis shows: repeating a study due to incorrect classification is almost always more expensive than the additional expense of a properly designed GLP study.

Can a GLP-like study be retroactively converted into a GLP study?

Retroactive formal GLP compliance cannot be established. Non-GLP-compliant data may still be submitted depending on the submission context, but must then be disclosed as such and justified. If it is later determined that the data should be included in a regulatory submission, the sponsor must assess whether the collected data is sufficiently usable for regulatory purposes; otherwise, a repeat study in full GLP compliance may be required.

When should I request a pre-submission meeting with the FDA?

Especially if the approval pathway is unclear or the question of GLP vs. GLP-like cannot be clearly answered. Early communication with regulatory authorities is one of the most effective tools for risk reduction.

Sources & further links

External references

• OECD – Principles of Good Laboratory Practice
• FDA / eCFR – 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies)
• EU – Directive 2004/10/EC on the application of the principles of Good Laboratory Practice
• ISO – ISO 13485:2016 “Medical devices — Quality management systems — Requirements for regulatory purposes”

Internal Links

• GLP practices in MedTech: 10 key elements for audit-ready reports
• Medical Device Compliance under the EU MDR: GLP compliance as part of MDR conformity
• ISO 13485: Where GLP and QMS documentation overlap
• Choosing a Preclinical CRO: GLP level as a central question in the scoping call

As of: May 2026 | Last reviewed: May 2026