News
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Is Lipotype GCP-certified?
No – and that distinction matters. GCP compliance is an inspectable state, not a certifiable standard. Lipotype should not be described as “GCP-certified.” The correct terminology is “GCP-aligned,” “GCP-compliant,” or “inspection-ready.”
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What does “GCP-compliant” mean for a bioanalytical laboratory?
GCP (Good Clinical Practice) is not a certification but an inspectable state of readiness demonstrated through quality systems, documented procedures, trained personnel, and comprehensive audit trails. For Lipotype, it means our analytical workflows, documentation, and quality management system are aligned with ICH E6(R3) and the EMA GCLP Reflection Paper (EMA/INS/GCP/532137/2010), so data we generate is traceable, audit-ready, and suitable for integration into a regulatory submission.
