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.

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.”

ALCOA++ is the data integrity framework requiring that all records be Attributable, Legible, Contemporaneous, Original, and Accurate – plus Complete, Consistent, Enduring, and Available. During GCP analysis, every action at Lipotype is recorded contemporaneously and traceably in accordance with these principles, including sample chain of custody, instrument logs, QC batch records, and deviation documentation.

Signed contractual document including a Quality Agreement (QA), Data Transfer Agreement (DTA), Study Analysis Protocol (SAP), must all be executed before analysis starts.

The SAP is a sponsor-agreed analytical plan that governs all aspects of the study – methods, acceptance criteria, QC strategy, and deviation handling. It must be reviewed and signed by both parties before any samples are analyzed. Any deviation from the SAP during the study is a formal event requiring documentation and Quality Management sign-off in GCP compliant tier.

Yes. CDISC SDTM-formatted data transfer is available as a module within the Data Transfer Agreement, alongside a simple format option and a customized format. CDISC SDTM format is typically required for regulatory submissions to the FDA.

Data, QC records, and the final Bioanalytical Report are archived for a minimum of 25 years under controlled access for regulatory-grade projects. This is a genuine long-term operational commitment reflected in project pricing and contract structures.

No. Data generated under RUO conditions cannot be retrospectively reclassified as GCP/GCLP-compliant. If the regulatory intent of a study changes, the bioanalytical work must be restarted under a properly controlled framework from sample receipt onward.
This is a common and avoidable situation. Lipotype addresses it proactively by completing a regulatory tier assessment with every new customer before project initiation – ensuring the right quality framework is in place from day one, regardless of whether a clinical submission is immediately anticipated.

Any expansion to an ongoing GCP study constitutes a protocol amendment and requires formal QM approval. This is handled through a -formal change request. This protects data integrity and ensures traceability of the analytical record.

Sponsor audits are standard practice for GCP vendor qualification and Lipotype welcomes them. Audit scheduling is coordinated through Quality Management, not Operations or Sales. Please raise this requirement early in the project conversation.

Lipotype is the bioanalytical subcontractor, not the regulatory submission holder. Lipotype’s deliverable is regulatory-grade bioanalytical data and documentation (SAP, BAR, DTA) supporting regulatory submissions. TMF ownership, submission responsibilities, and post-market surveillance obligations remain entirely with the sponsor.