GLP certification
Good Laboratory Practice — OECD certified
EnviroLab holds GLP certification confirming that non-clinical health and environmental safety studies conducted at our facility meet OECD Good Laboratory Practice standards required for regulatory submissions to the JFDA, EMA, and US FDA.
What is GLP?
Good Laboratory Practice (GLP) is an OECD-defined quality framework that governs the organisational processes and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. GLP certification is a prerequisite for studies submitted to regulatory authorities such as the US EPA, the European Chemicals Agency (ECHA), and national medicines agencies.
Why GLP matters for pharmaceutical submissions
For pharmaceutical manufacturers, GLP-certified data is required for toxicology, genotoxicity, and safety studies submitted as part of drug registration dossiers. EnviroLab's GLP certification means that method validation studies, stability data, and analytical results generated at our facility meet the evidentiary standards required by the JFDA, EMA, and US FDA for regulatory submissions.
Study integrity
Every study is conducted under a written protocol with a designated Study Director responsible for the overall conduct and final report.
Data traceability
Raw data, instrument records, and audit trails are archived in a manner that allows full reconstruction of any study.
Quality assurance unit
An independent QA unit inspects studies in progress and audits final reports before submission to sponsors or regulators.
GLP-applicable studies at EnviroLab
- Analytical method validation to ICH Q2(R1)
- Stability studies for drug substances and drug products
- Nitrosamine testing, risk assessment and confirmatory testing
- Extractables and leachables studies
- Heavy metals and elemental impurity testing (ICH Q3D)
- Residual solvent analysis (ICH Q3C)