The Scope of a GLP Audit
A Good Laboratory Practices audit is a comprehensive examination of your laboratory’s compliance with regulatory requirements. Whether conducted by the FDA, OECD member authorities, or your own internal auditors, a GLP audit covers every aspect of your non-clinical study operations.
Understanding the critical areas that auditors will scrutinize is the first step toward successful audit preparation. This article outlines the key areas every laboratory should review before a GLP audit, helping you identify potential compliance gaps and take corrective action before inspectors arrive.
Auditors examine not just your documentation but also your facilities, equipment, personnel qualifications, and quality systems. They look for evidence that GLP principles are embedded in your daily operations, not just documented in policies that are not followed. By reviewing these critical areas thoroughly, you can transform a potentially stressful audit experience into a smooth and successful inspection.
Critical Area 1: Personnel and Training
What Auditors Review
Auditors will examine the qualifications, training, and responsibilities of all personnel involved in GLP studies. This includes Study Directors, Principal Investigators, QA personnel, and technical staff.
Key Compliance Requirements
Documented job descriptions defining GLP responsibilities are essential. Complete training records for all personnel, including initial and ongoing training, must be maintained. There must be clear designation of Study Directors and Principal Investigators. Training on updated SOPs and regulatory changes must be documented and current.
Common Findings
Inadequate training records are frequently cited in FDA 483 observations. Personnel performing tasks without appropriate training is a significant compliance gap. Unclear roles and responsibilities can lead to confusion and errors. QAU personnel involved in study conduct compromises the independence required for effective quality assurance.
Review Checklist
Verify all personnel have current job descriptions. Confirm training records are complete and up-to-date. Ensure Study Directors are properly designated and qualified. Check that QAU operates with genuine independence. Review training matrices for all personnel to confirm coverage.
Critical Area 2: Quality Assurance Unit
What Auditors Review
Auditors will evaluate the independence, effectiveness, and documentation of your QAU activities. The QAU is the cornerstone of GLP compliance, and its shortcomings are a frequent source of regulatory findings.
Key Compliance Requirements
QAU independence from study conduct is non-negotiable. Study-based inspections of all studies must be conducted and documented. Facility-based inspections of laboratory operations must occur regularly. Process-based inspections of critical procedures must be performed. Protocol and final report reviews must be completed and documented. All QAU activities must be thoroughly documented.
Common Findings
QAU personnel participating in studies they inspect is a critical violation. QAU reporting to Study Directors rather than senior management compromises independence. Insufficient QAU resources leading to superficial inspections is a common issue. Missing or inadequate QAU inspection records are frequently cited.
Review Checklist
Confirm QAU independence from study conduct. Verify study-based inspection records for all studies. Review facility-based inspection schedules and reports. Check process-based inspection documentation. Ensure protocol and final report reviews are documented.
Critical Area 3: Facilities and Equipment
What Auditors Review
Your laboratory’s physical infrastructure and equipment form the foundation of GLP compliance. Auditors will examine whether facilities are adequate, equipment is properly maintained, and systems are validated.
Key Compliance Requirements
Separate laboratory space for routine and specialized procedures must be provided. Environmental controls including temperature, humidity, and ventilation must be documented and monitored. Equipment calibration must occur at defined intervals. Maintenance records for all equipment must be complete and accessible. Computerized systems must be validated with audit trails. Controlled access to electronic systems must be maintained.
Common Findings
Inadequate separation of test systems or species is a frequent violation. Missing or incomplete calibration records are commonly cited. Unvalidated computerized systems pose significant data integrity risks. Inadequate environmental monitoring can compromise study validity. Poor equipment maintenance documentation indicates systemic compliance gaps.
Review Checklist
Verify facility layout meets GLP requirements. Check equipment calibration records and certificates. Review maintenance logs for completeness. Confirm computerized systems are validated. Verify environmental monitoring records are complete and current.
Critical Area 4: Documentation and Data Integrity
What Auditors Review
Documentation is at the heart of GLP compliance. Auditors will examine study plans, raw data, final reports, SOPs, and all other documentation to ensure data integrity and traceability.
Key Compliance Requirements
Approved written study plans for all studies must be in place. Raw data must be recorded promptly and legibly. Traceable modifications to data must be documented. Accurate final reports reflecting raw data must be prepared. SOPs for all activities must be current and available. Secure archiving of plans, data, and samples must be maintained.
Common Findings
Corrections that obscure original entries are a major red flag. Missing signatures or dates indicate poor documentation practices. Failure to document deviations compromises study integrity. Data recorded on loose notes before transcription is unacceptable. Inadequate archival procedures risk data loss. Missing or outdated SOPs indicate systemic compliance issues.
Review Checklist
Verify study plans are approved and documented. Check raw data for completeness and legibility. Review data modifications for traceability. Confirm final reports accurately reflect raw data. Ensure all activities have current SOPs. Verify archival procedures are in place and functioning.
How GxP Cellators Can Help You Prepare for a GLP Audit
At GxP Cellators, we have conducted over 500 GLP audits for clients worldwide. Our certified GLP and IRCA auditors bring extensive experience in identifying compliance gaps and helping laboratories achieve GLP readiness. We offer comprehensive pre-audit reviews covering all critical areas, helping you identify and address potential findings before regulators arrive.
Our team includes professionals with RQAP-GLP and IRCA Auditor certifications, ensuring that our auditing methodologies comply with international standards for management systems and technical compliance. We perform GLP audits on behalf of clients and sponsors, ensuring compliance with OECD guidelines and 21 CFR Part 58.
Our services include:
Internal gap assessments covering all ten OECD GLP sections and corresponding subparts of 21 CFR Part 58
Sponsor-side audits of CROs including pre-study qualification, for-cause investigations, and ongoing monitoring
Full-spectrum GLP study audits covering toxicology, pharmacokinetics, bioanalytical method validation, genotoxicity, reproductive toxicology, carcinogenicity, dermal and ocular toxicology, and ecotoxicology
Detailed audit reports with major and minor non-conformities, observations, and CAPA tracking logs
CAPA support and verification to ensure corrective actions are effective
Why sponsors choose us: We speak both the regulatory language and the scientific language. Our findings are factual, evidenced, and actionable. As an independent third-party audit firm, we have no organizational biases or conflicts of interest. Our audit reports carry greater credibility with regulatory authorities, clients, and business partners.
Our global presence spans Saskatchewan, Calgary, Toronto, North Carolina, Indiana, and Frankfurt, enabling us to deploy auditors worldwide and understand local regulatory nuances while upholding the OECD framework.
Ready to review your laboratory’s critical areas? Let GxP Cellators help you achieve GLP readiness with confidence.
Reach out to us today to schedule your GLP audit.
Email:
Phone: +1 (306) 715-9460
Website: /gxp-auditing/
GxP Cellators – Your Certified GLP Audit Partners
