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GxP Solutions provides regulatory-grade GxP audit services aligned with FDA inspection methodology and global regulatory expectations.
Our audits deliver clear, actionable findings that support remediation, inspection readiness, and long-term compliance.
Former FDA Investigator methodology
Risk-based inspection logic
FDA-style observations
Practical remediation guidance
Executive-ready reporting
A Good Clinical Laboratory Practice (GCLP) audit is a systematic, independent evaluation of a laboratory’s processes, systems, and records to confirm that clinical trial laboratory activities are conducted in a consistent, accurate, reliable, and traceable manner—and that generated data are fit for regulatory submission.
GCLP bridges Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and is specifically applied to laboratories that support clinical trials (central labs, specialty labs, bioanalytical labs, biomarker labs, and genetic testing labs).
The main goal of GLP regulations is to ensure compliance in the conducting of nonclinical laboratory studies. These studies investigate certain test articles and test substances.
Conducting GLP audits is a required step in obtaining premarket approval of regulated products.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analyses of samples from clinical trials while ensuring the purpose and objectives of the Good Clinical Practice principles are maintained.
The main objective of developing a quality system using GCLP standards was to provide research data that are of high quality and reliable while also achieving GCLP accreditation. GCLP was chosen as the best platform to achieve this because samples used for this research were being received from clinical trials.
Laboratories are a fundamental source of scientific evidence critical for clinical research and decision-making in clinical diagnostics and patient care. Because of this, laboratories must meet quality and management standards so that the results they produce are unbiased, accurate, and complete. GCLP provides a bridge between GCP and GLP audits and regulations.
GCLP compliance auditing allows for:
