GLP Auditing Services: Ensuring Compliance with 21 CFR Part 58 & OECD Standards
In drug development, the integrity of non-clinical data is essential. Good Laboratory Practice (GLP) ensures that safety studies submitted to regulators are credible, traceable, and reproducible.
For sponsors working with Contract Research Organizations (CROs), auditing is both a regulatory requirement and a strategic necessity. GLP compliance applies to a wide range of study types, each with distinct risks.
GxP Cellators Consultants provides independent GLP auditing services to sponsors worldwide. Our expertise in global regulations ensures your data is inspection-ready for both US and international submissions.
This blog outlines the essentials of GLP auditing, the range of studies we cover, and our systematic approach to global compliance.
What is GLP Auditing?
A GLP audit is a systematic and independent examination of a non-clinical safety study’s entire lifecycle from protocol development to the final report. The goal is to verify that the study was conducted in compliance with GLP regulations, ensuring that the data generated is of high quality and integrity.
For regulatory submissions, audits serve as a critical checkpoint to identify compliance gaps before inspection by the FDA, EMA, or OECD authorities.
The Scope of GLP Studies: Where We Audit
“GLP” encompasses a broad range of non-clinical studies evaluating product safety. GxP Cellators audits the full spectrum of these regulatory studies:
- Toxicology Studies: The cornerstone of GLP. We audit acute, sub-chronic, and chronic toxicity studies, including rodent and non-rodent species. This involves scrutinizing necropsy records, histopathology reports, and dose formulation analyses .
- Pharmacokinetics (PK) & Toxicokinetics (TK): We verify the accuracy of data used to determine drug exposure levels, ensuring that blood sampling times, analytical runs, and calculations are precise.
- Bioanalytical Method Validation: We audit assay validation for drug and metabolite measurement, ensuring compliance with regulatory criteria for sensitivity, selectivity, and reproducibility.
- Genotoxicity Studies: We audit in-vitro and in-vivo tests for genetic mutations, ensuring proper controls and cell line management.
- Reproductive Toxicology (Segments I, II, III): We review fertility, teratology, and peri/post-natal studies, emphasizing meticulous record-keeping.
- Carcinogenicity Studies: We provide oversight for long-term studies, focusing on animal husbandry, pathology, and data integrity.
- Dermal and Ocular Toxicology: We audit specialized studies, including dosing techniques and irritation scoring.
- Ecotoxicology: We ensure GLP compliance in aquatic and terrestrial toxicity tests for environmental impact assessments.
Our Global Compliance Mandate: OECD & 21 CFR Part 58
Sponsors often face challenges due to differences in international regulations. European submissions must comply with OECD GLP standards, while US submissions must comply with 21 CFR Part 58.
GxP Cellators Consultants has the expertise to harmonize both regulatory frameworks. We audit to ensure studies meet the standards of the target authority, regardless of CRO location. Our consultants identify discrepancies against the global GLP compliance standard.
The GxP Cellators 4-Step Audit Process
At GxP Cellators, we follow a rigorous, transparent, collaborative, and effective four-step methodology.
Step 1: Pre-Inspection and Checklist Development
Auditing begins long before we step onto the CRO floor. We conduct a thorough pre-inspection phase in which we review the study protocol, the CRO’s Standard Operating Procedures (SOPs), and the CRO’s previous audit history.
We develop a comprehensive, risk-based checklist tailored to your specific study, whether a 28-day rat toxicity study or a complex bioanalytical validation. The checklist covers critical areas such as:
We develop a comprehensive, risk-based checklist tailored to your specific study, whether a 28-day rat toxicity study or a complex bioanalytical validation. The checklist covers critical areas such as:
- Personnel training and Job descriptions.
- Master schedule review.
- Equipment calibration and maintenance logs.
- Test article characterization and formulation.
- Raw data integrity and audit trail reviews .
Step 2: Conducting the On-Site Audit
During the audit, we conduct in-depth interviews with the Study Director and Quality Assurance Unit (QAU) and observe laboratory practices to ensure they align with written procedures.
We trace data from the animal receipt log through dosing, observations, and the final pathology report, verifying strict adherence to ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) data integrity principles.
We trace data from the animal receipt log through dosing, observations, and the final pathology report, verifying strict adherence to ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) data integrity principles.
Step 3: Final Report Preparation
Following the audit, we compile a detailed, objective, and actionable report. Findings are categorized, and each observation is linked to the relevant regulation, helping sponsors and CROs address specific issues. The true value of an audit lies in the remediation it enables. We work with you and your CRO to review the proposed Corrective and Preventive Actions (CAPA) .
Once the CAPA plan is implemented, GxP Cellators doesn’t just walk away. We offer follow-up services to verify the effectiveness of the CAPA, ensuring that the root cause has been eliminated and that the same issue will not resurface during a future regulatory inspection.
Once the CAPA plan is implemented, GxP Cellators doesn’t just walk away. We offer follow-up services to verify the effectiveness of the CAPA, ensuring that the root cause has been eliminated and that the same issue will not resurface during a future regulatory inspection.
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Why Partner with GxP Cellators?
Data integrity is critical to patient safety. You need a partner who understands the scientific and regulatory nuances across the GLP spectrum.
- Regulatory Mastery: Deep expertise in both OECD and FDA (21 CFR Part 58) guidelines.
- Sponsor Advocacy: We audit exclusively on behalf of sponsors, ensuring your interests are protected.
- Full Scope Coverage: From single-dose tox to reproductive toxicology and bioanalysis.
- Global Reach: Experience auditing CROs in North America and Europe.
- Lifecycle Partnership: From pre-audit preparation to CAPA effectiveness verification, we support you throughout the process. Ensure your GLP studies are compliant, credible, and inspection-ready.
Contact GxP Cellators Consultants to schedule a consultation or request our auditing services.
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