Quality & Compliance
Good Laboratory Practice (GLP).
We help research and testing laboratories in the pharmaceutical and medtech industries establish and document GLP-compliant processes and prepare effectively for GLP inspections by regulatory authorities in accordance with OECD principles.
How do pharmaceutical laboratories comply with GLP requirements in accordance with OECD principles?
Good Laboratory Practice (GLP) is mandatory for nonclinical safety studies. Testing facilities often encounter compliance gaps in this regard:
- Archiving requirements and sample management do not comply with the strict OECD GLP requirements.
- Standard operating procedures (SOPs) are missing, outdated, or not structured in a way that complies with GLP.
- Inspections of testing facilities by national GLP authorities (e.g., BfR, BfArM) result in regulatory non-compliance.
- Audit trails and raw data management (both electronic and paper-based) do not meet data integrity requirements.
Has your testing facility been successfully inspected in the past three years without any significant GLP violations?
Our GLP consulting services.
We provide systematic support to GLP laboratories, from the initial gap analysis through to successful regulatory approval.
GLP Gap Analysis & Readiness Assessment
Systematic assessment of your testing facility’s status against the current OECD principles. Development of a prioritized action plan to achieve GLP compliance.
GLP Process & SOP Development
Development of GLP-compliant SOPs for all core processes: study management, raw data entry, archiving, sample management, equipment qualification, and personnel management.
GLP Audit & Pre-inspection
Simulation of a real GLP inspection by experienced auditors. Includes a findings report, a CAPA plan, and preparation of the test facility management for interviews.
Raw Data & Data Integrity
Evaluation and optimization of raw data collection and archiving (minimum 15 years). Audit trail concepts for LIMS and electronic laboratory systems in accordance with GAMP5.
Frequently Asked Questions About Good Laboratory Practice (GLP).
To which studies does GLP apply?
GLP applies to non-clinical safety studies: toxicity studies, genotoxicity tests, environmental toxicity studies, and preclinical studies submitted for regulatory approval. Basic academic research is not subject to GLP.
What is the difference between GLP and GMP?
GLP applies to non-clinical laboratory studies (safety testing on test systems). GMP applies to the manufacture and release of medicinal products. Both are GxP regulations, but they cover entirely different areas.
Who oversees GLP in Germany?
GLP regulatory oversight is a matter for the federal states. Agencies such as the BfR, regional councils, and state offices conduct inspections and grant GLP inspection approvals. At the federal level, the BfArM coordinates these activities.
What is raw data according to GLP?
Raw data refers to all original records and certified copies of observations from a study: laboratory notebooks, measurement logs, printouts, and dictations. GLP requires that these be archived in their entirety for at least 15 years.
Additional expertise in the area of Quality & Compliance.
Expertise
GxP Audit Consulting
Professional auditing across all GxP areas (GMP, GLP, GCP).
ExpertiseComputer System Validation
Securely validating LIMS, ELNs, and electronic laboratory IT systems (GAMP5).
ExpertiseInspection Readiness
Methodical preparation of your organization for upcoming government inspections.
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