Integrity is essential in drug development. Pharmaceutical and biotechnology companies must ensure that non-clinical studies comply with Good Laboratory Practice (GLP) to support successful regulatory submissions.
Sponsors submitting to the FDA or an OECD Member Authority face close scrutiny of raw data, facility operations, and study conduct. Sponsor-led audits are therefore essential.
Under 21 CFR Part 58 (FDA) and OECD Principles of GLP, sponsors are responsible for the validity of nonclinical studies. However, most lack the resources or expertise to audit every testing facility or bioanalytical site internally.
As a result, many sponsors engage expert consultants to conduct GLP audits on their behalf.
Complexity of Nonclinical Study Audits
Auditing a testing facility differs significantly from routine financial or internal audits. GLP audits require in-depth knowledge of infrastructure, SOPs, and qualified staff.
- Archives: Verify the integrity of raw data and specimens, ensuring protection from damage or unauthorized access. The QA unit must independently monitor the study.
- Data Integrity: Cross-reference raw data, both paper and electronic, with final reports to identify inconsistencies, often using ALCOA+ principles.
Failure in any of these areas may result in a Form 483, a warning letter, or rejection of a New Drug Application (NDA).
Why Hire a Consultant to Perform GLP Audits?
Internal audits can introduce risks such as auditor fatigue or unconscious bias. Engaging, a third-party GLP auditing consultant offers these benefits:
- Objectivity: Unbiased review of the testing facility’s compliance.
- Regulatory Agility: Experienced consultants understand current priorities of global regulatory agencies.
- Cost Efficiency: Sponsors access targeted expertise as needed, avoiding the cost of maintaining an internal global audit team.
Introducing GxP Cellators: Your Certified GLP Audit Partners
To safeguard your nonclinical studies, engage a certified GLP auditor rather than a general consultant.
At GxP Cellators, we conduct comprehensive GLP audits for sponsors. We ensure every phase of the study, from protocol review to final reporting, meets OECD and 21 CFR Part 58 requirements.
Why GxP Cellators?
Our team includes certified GLP auditors with respected industry certifications:
- RQAP-GLP (Registered Quality Assurance Professional – GLP): This certification demonstrates mastery of GLP regulations and principles, ensuring our auditors are recognized globally as leaders in the field.
- IRCA Certified Auditor (International Register of Certified Auditors): This certification ensures our auditing methodologies comply with international standards for management systems and technical compliance.
By leveraging these certified professionals, GxP Cellators ensures your testing facilities and sites are inspected against the highest industry benchmarks.
When you engage GxP Cellators for a GLP audit, you can expect a rigorous process tailored to your drug development program:
- Facility Audits: We inspect the testing facility’s infrastructure, equipment calibration, and environmental controls to ensure they support study validity.
- Study-Based Audits: We reconstruct the study from raw data to final report, verifying every calculation, observation, and statistical analysis.
- Vendor/Third-Party Audits: If your testing facility subcontracts bioanalytical work or toxicology services, we audit those sites to ensure end-to-end compliance.
- Comprehensive Reporting: We provide a detailed audit report with clear classification of findings (Critical, Major, Minor) and practical corrective action plans (CAPAs) to address any gaps before regulatory submission.
Secure Your Nonclinical Data Integrity
In drug development, your nonclinical data forms the foundation of your regulatory submission. Don’t leave its integrity to chance. Partner with auditors who hold RQAP-GLP and IRCA certifications. Partner with GxP Cellators.
We ensure your CROs and testing sites are fully compliant with global standards, allowing you to focus on developing life-saving therapies.
Ready to strengthen your GLP compliance strategy?
Contact GxP Cellators today to schedule your GLP audit.
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