GLP OECD Internal Auditor Certification – Ensure Compliance Across Single‑Site and Multi‑Site Nonclinical Studies
Good Laboratory Practice (GLP), as defined by the OECD, is the global gold standard for nonclinical health and environmental safety studies. Whether you operate a single test facility or manage complex multi‑site studies with Principal Investigators across multiple locations, having a certified internal auditor is essential for maintaining GLP compliance, passing regulatory inspections, and safeguarding data integrity.
This blog introduces the GLP OECD Internal Auditor Certification program – a comprehensive, self‑paced training designed for quality assurance professionals, Study Directors, Principal Investigators, and laboratory personnel.
GLP Internal Auditor Certification (OECD Focused) I GLP Trainings
Why GLP OECD Internal Auditing Matters
Nonclinical studies must comply with the OECD Principles of GLP (as revised in 1997) to be accepted under the Mutual Acceptance of Data (MAD) among OECD member countries. A robust internal audit programme helps you:
- Detect non‑conformities before a regulatory inspection.
- Ensure the integrity of raw data, final reports, and specimen archives.
- Manage multi‑site studies with clear Principal Investigator delegation and communication.
- Prepare your facility for inspections by national GLP compliance monitoring authorities.
Internal auditors act as the second line of defence – independent from study conduct, they verify that every phase of a study meets GLP requirements.
What the GLP OECD Internal Auditor Certification Covers
Our training program is built directly from the OECD Principles of GLP and the OECD Consensus Document on Multi‑Site Studies (No. 13). It covers the full spectrum of GLP requirements and auditing practices, including:
Core GLP Areas Audited
- Test facility organisation and personnel – management responsibilities, Study Director, Principal Investigator, study personnel.
- Quality Assurance Programme – study‑based, facility‑based, and process‑based inspections; QA statement in the final report.
- Facilities, apparatus, and test systems – animal care, biohazard isolation, equipment calibration, reagent labelling.
- Test and reference items – characterisation, stability, homogeneity, batch retention, handling.
- Standard Operating Procedures (SOPs) – approval, availability, deviation management.
- Study performance – study plan, amendments, deviations, raw data recording, audit trails.
- Reporting and archives – final report content, QA statement, archive indexing and retention.
Multi‑Site Study Auditing (Unique Focus)
- Role of the Principal Investigator and delegation of phases.
- Communication and master schedule requirements across sites.
- Single study plan, single Study Director, single final report.
- Lead Quality Assurance and test site QA coordination.
Internal Audit Process (Based on ISO 19011)
- Audit programme management, planning, and risk assessment.
- Audit checklist design and sampling plans.
- Evidence collection through interviews, observation, and document review.
- Classification of major/minor non‑conformities and observations.
- Writing non‑conformity reports (NCR) and tracking CAPA.
- Audit closure and contribution to management review.
Who Should Take This Certification?
The GLP OECD Internal Auditor Certification is ideal for:
- Quality Assurance personnel – responsible for independent study monitoring and inspections.
- Study Directors – who need to understand how their studies are audited.
- Principal Investigators – managing delegated phases of multi‑site studies.
- Test facility management – ensuring overall GLP compliance.
- Archivists, laboratory supervisors, and sponsor representatives.
No prior auditing experience is required, but a basic GLP awareness training (4+ hours) is recommended.
Certification Pathway
Participants complete five modules followed by a practical case study and a witnessed internal audit.
- Pass each module quiz (80% or higher).
- Submit an audit plan, checklist, findings, and an NCR.
- Complete a supervised internal audit.
Certification is valid for three years, with annual audit activity and continuing education requirements.
Deliver the Training to Your Entire Team – Corporate & On‑Site Programs
GxP Trainings offers flexible solutions for organisations that need to train multiple internal auditors or prefer instructor‑led on‑site delivery.
Corporate Training (Larger Teams)
- Dedicated cohort with customised scheduling.
- Group discounts and volume pricing.
- Centralised reporting and progress tracking.
On‑Site Training (At Your Facility)
- In‑person or virtual instructor‑led sessions.
- Tailored examples based on your test facility’s specific studies.
- Interactive workshops using your own SOPs, study plans, and raw data formats.
Contact us to discuss your team’s needs:
📧 info@gxpcellaotrs.com
Start Your GLP OECD Internal Auditor Journey Today
Don’t wait for a regulatory inspection to reveal gaps in your GLP compliance. Equip your team with the knowledge and skills to audit confidently – from single‑site laboratories to complex multi‑site international studies.
Request a quote or schedule a discovery call: info@gxpcellaotrs.com
About GxP Trainings
GxP Trainings specialises in regulatory compliance education for pharmaceutical, biotechnology, medical device, and CRO organisations. Our course catalogue includes GDP, GLP, GCP, GMP, and ISO 19011 auditor programs. All courses are developed by industry experts and updated to reflect current regulations and guidelines.
