How do test facilities meet GLP requirements under the OECD Principles without being cited during regulatory monitoring?
We support research and test facilities across pharma, biotech, MedTech and IVD in building GLP-compliant processes in line with the OECD Principles of Good Laboratory Practice: from the gap analysis through SOPs, raw data and archive management, all the way to preparing for the test facility inspection. The limiting factor is rarely a single document, but the chain of evidence: a test facility passes the inspection on the traceability from raw data to final report, not on individual SOPs.
- Pharma
- Biotech
- MedTech
- IVD
Overview
Which GLP requirements arise in test facilities?
GLP support for pharma, biotech, MedTech and IVD · OECD Principles of Good Laboratory Practice
Last updated: 2026-06-13
The OECD Principles of Good Laboratory Practice (GLP) are mandatory for non-clinical safety studies whose results are submitted to authorities for the approval of medicinal products, medical devices, biocides or chemicals. In the EU these principles are harmonised through Directive 2004/10/EC; in Germany implementation is handled via the Chemicals Act (ChemG). The points where test facilities most often get stuck during the inspection:
- Standard operating procedures (SOPs) are missing, outdated or not structured in a GLP-compliant way, so that the actual conduct deviates from the documented method.
- Raw data capture and audit trail do not meet the GLP requirements for data integrity, particularly with electronic laboratory systems (LIMS) that lack validated traceability.
- Archiving and sample management do not conform to the OECD principles, for example with regard to retention periods, access control and retrievability of study records.
- The Quality Assurance Unit (QAU) is not set up with sufficient independence from study direction, or its study-based, process-based and facility-based inspections are not documented without gaps.
- Traceability from the raw data through the evaluation to the final report is broken, so that the authority cannot follow the study integrity end to end.
Services
How we support you
GLP gap analysis & readiness assessment
Systematic assessment of the test facility's GLP status against the OECD principles. The result is a prioritised action plan with concrete steps for each core process on the path to GLP compliance.
GLP process & SOP development
Preparation of GLP-compliant SOPs for all core processes: study management, raw data capture, archiving, sample management, equipment qualification and personnel qualification, including the master SOP list with version control.
Raw data & data integrity
Assessment and optimisation of raw data capture, audit trail and archiving in line with GLP. Audit trail and access concepts for electronic laboratory systems (LIMS) with documented traceability.
Learn more →Setting up the Quality Assurance Unit (QAU)
Establishing a QAU independent of study direction, with an inspection plan for study-based, process-based and facility-based inspections, along with documented QAU statements for every study.
GLP mock audit & inspection preparation
Simulation of a regulatory test facility inspection by experienced auditors. Complete findings report with CAPA plan and preparation of test facility management for the inspection interview.
Learn more →How we work together
What it comes down to
The OECD Principles of Good Laboratory Practice do not assess polished documents, but an end-to-end chain of evidence. Three strands have to line up, and in the right order: the SOPs define how an activity is to be carried out. The raw data capture has to prove that the study was conducted exactly that way. And the Quality Assurance Unit has to confirm independently that the final report accurately reflects the raw data. Whoever clarifies the raw data definition or the audit trail in the LIMS too late loses precisely that strand as the critical point, because integrity cannot be created after the fact, only documented or not.
This is exactly where we come in. At the outset, the gap analysis makes visible which strand is critical, before SOPs are written and systems are validated. That shifts the effort to the front: into defining what constitutes the raw datum in the specific procedure and how the Quality Assurance Unit is set up to be independent, rather than into the test facility inspection, where a broken chain of evidence is no longer repairable and GLP recognition is at risk.
Our approach
Our approach
Step
Result
Gap analysis
Prioritised action list for each GLP core process: where the test facility stands against the OECD principles, what is critical, and what is effort.
SOP & process build-up
GLP-compliant SOPs for study direction, raw data, archive, samples, equipment and personnel, with version control and a master list.
Data integrity & LIMS
An assessed and traceable audit trail, documented access control, and a raw data lifecycle from capture through archiving.
QAU & study integrity
An independent Quality Assurance Unit in operation, the inspection plan worked through, and end-to-end traceability up to the final report.
Mock audit
Findings report with CAPA plan, critical findings closed, inspection interviews prepared.
Test facility inspection
Supported regulatory inspection, structured handling of the citations, GLP recognition obtained or confirmed.
Common pitfalls
Where projects commonly fail
SOPs describe a target process that diverges from actual practice.
The inspection compares raw data and laboratory notebooks against the valid SOP; any deviation without documented justification becomes a citation, regardless of how cleanly the SOP is worded.
The raw data definition is unclear.
If it is not established what constitutes the raw datum in the specific procedure (instrument printout, electronic data record or laboratory notebook entry), a gap opens in the chain of evidence that the authority routinely addresses.
The audit trail in the LIMS is not validated or can be disabled.
If it can be altered after the fact who captured or corrected a measurement, GLP data integrity cannot be demonstrated; this ties closely to computer system validation and 21 CFR Part 11 where there is an FDA nexus.
The Quality Assurance Unit is not independent.
If the QAU effectively reports to study direction, or documented QAU inspections are missing, one of the central pillars of the OECD principles falls away, which weighs heavily in the facility inspection.
The archive meets the requirements formally but not functionally.
Retention periods are on file, yet access control, a named archivist and demonstrable retrievability of the study records are missing, so the integrity of long-term storage is not substantiated.
FAQ
Frequently asked questions
Sources
- OECD Principles of Good Laboratory Practice (GLP): primary text
- Directive 2004/10/EC and Directive 2004/9/EC (EU harmonisation and GLP inspection)
- Chemicals Act (ChemG): national implementation of the GLP principles in Germany
- https://theentourage.de/expertise/good-laboratory-practice/ (existing page content, revised)
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Case Studies
What this looks like in practice
Regulations & standards considered
- OECD Principles of Good Laboratory Practice (GLP)
- Directive 2004/10/EC (harmonisation of GLP principles in the EU)
- Directive 2004/9/EC (inspection and verification of Good Laboratory Practice)
- Chemicals Act (ChemG): national implementation of the GLP principles in Germany
Related topics
GxP Audits (GMP, GLP, GCP) →
Cross-GxP audits beyond GLP
Computer System Validation (CSV) →
Validation of LIMS and electronic laboratory systems for GLP data integrity
Inspection Readiness →
Preparation for the regulatory test facility inspection
Quality Management →
Overarching QM system into which the GLP processes are embedded
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