Why GLP Auditing Is a Regulatory Imperative
Good Laboratory Practice (GLP) is the backbone of nonclinical safety testing. Whether you follow the OECD Principles of GLP (revised 1997) – accepted in over 37 countries through the Mutual Acceptance of Data (MAD) – or the US FDA 21 CFR Part 58 regulations, one truth remains: a single GLP gap can invalidate years of research.
Regulators expect:
A single point of study control – the Study Director.
An independent Quality Assurance Programme that performs study‑based, facility‑based, and process‑based inspections.
Raw data that is recorded directly, promptly, and legibly, with changes that never obscure the original entry.
Test and reference items fully characterised (purity, stability, homogeneity) with reserve samples retained.
Archives that are secure, indexed, and access‑controlled.
Yet, in real‑world laboratory environments – from Montreal to San Francisco to Singapore – we repeatedly find the same issues: missing calibration records, undocumented deviations, inadequate QAU independence, and incomplete audit trails.
GxP Cellators exists to find and fix those gaps before a regulatory inspector does.
Our GLP Auditing Services – Tailored for Canada, USA & Global Operations
We offer two main service streams, both delivered by auditors trained in OECD GLP and 21 CFR Part 58.
1. Internal GAP Assessments (for Test Facilities)
A proactive, confidential audit of your entire GLP system. We cover all ten OECD GLP sections and the corresponding subparts of 21 CFR Part 58.
What we audit:
Test facility organisation & personnel – job descriptions, training records, designation of Study Directors and Principal Investigators (multi‑site studies).
Quality Assurance Programme – independence, master schedule, inspection records, QA statement in final reports.
Facilities – separation of test article storage from animal housing, archive security, waste disposal.
Apparatus & computerised systems – calibration traceability, validation documentation, full audit trail retention.
Test & reference items – characterisation, stability, homogeneity in vehicles, reserve samples (required for studies >4 weeks under 21 CFR 58.105).
SOPs – availability in lab areas, historical file, documented deviations.
Study performance – protocol approval before study initiation, raw data integrity (ink, dated, signed, changes justified).
Final report – Study Director signature, QA statement, archiving location.
Multi‑site studies – single study plan, documented communication, Principal Investigator delegation.
Output: A detailed audit report with major/minor non‑conformities, observations, and a CAPA tracking log. We also verify effectiveness of corrective actions – no rubber‑stamping.
2. Sponsor‑Side Audits of CROs (Contract Research Organisations)
Before you place your nonclinical study with a CRO – or if a study shows unexpected results – let us audit the CRO on your behalf.
We perform:
Pre‑study qualification audits – evaluate facilities, equipment calibration, QA independence, and personnel training.
For‑cause audits – investigate raw data, deviation logs, and audit trails when integrity is questioned.
Tox auditing services – deep dive into toxicology studies: test system health, dose formulation stability, necropsy documentation, histopathology specimen tracking.
Ongoing monitoring audits – verify that the Study Director remains the single point of control and that delegated phases (e.g., analytical chemistry) comply with GLP.
Why sponsors choose us: We speak both the regulatory language and the scientific language. Our findings are factual, evidenced, and actionable.
What Makes GxP Cellators Different?
| Feature | GxP Cellators Approach |
|---|---|
| Global regulatory reach | OECD GLP (MAD system) + 21 CFR Part 58. Your audit is valid for Health Canada, FDA, and any OECD member country. |
| Multi‑site expertise | We audit studies with Principal Investigators across remote locations, verifying communication mechanisms and master schedule cross‑references. |
| Raw data scrutiny | We check for the “golden rules”: direct, prompt, legible, dated, signed, changes with reason and no obscuring. |
| CAPA effectiveness | We don’t close an audit until we see objective evidence that the fix works – e.g., 3 months of clean raw data after retraining. |
| Confidentiality & independence | We never audit our own work. Full confidentiality agreements. |
Example – How We Saved a Sponsor from Study Rejection
A global pharmaceutical company engaged us to audit a CRO performing a 28‑day repeat‑dose toxicity study in rats (OECD Test Guideline 407). Our auditor discovered:
Finding: Test article in vehicle (corn oil) – no stability determination performed before study initiation.
Reference: OECD GLP 6.2.5 & 21 CFR 58.113.Classification: Major Non‑Conformity – the actual concentration administered over time was unknown.
Our immediate action: We notified the sponsor and the CRO’s management. The CRO halted dosing, performed retrospective stability analysis, and documented the deviation. The final report included an amendment explaining the impact.
Result: The sponsor’s NDA submission was accepted because they had a transparent, documented justification – thanks to the early audit finding. Without our audit, that study would have been rejected.
https://www.gxptrainings.com/course-category/glp-training/
Get Your GLP Audit Today – Protect Your Data, Your Submission, Your Reputation
Whether you are a test facility in Toronto, a sponsor in Boston, or a CRO operating globally – GxP Cellators is ready to deliver a thorough, professional GLP audit.
Contact us now
Let’s close your GLP gaps – before regulators find them.
GxP Cellators – Your trusted partner in GLP, GCP, GMP, and GVP auditing across Canada, the United States, and the world.
