SCOPE

This training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in the OECD Principles of Good Laboratory Practice (as revised in 1997). The program integrates GLP requirements for single‑site and multi‑site studies with internal auditing practices based on ISO 19011.

The participant learns both what the OECD GLP requires and how to plan, execute, report on, and close internal audits of those requirements.

Operational areas covered by this program include

• Test Facility Organisation and Personnel – test facility management responsibilities, Study Director responsibilities, Principal Investigator responsibilities (for multi‑site studies), study personnel responsibilities.
• Quality Assurance Programme – independence from study conduct, study‑based inspections, facility‑based inspections, process‑based inspections, QA statement in final report.
• Facilities – general requirements, test system facilities, facilities for handling test and reference items, archive facilities, waste disposal.
• Apparatus, Material and Reagents – design, calibration, maintenance, labelling, expiry date management.
• Test Systems – physical/chemical systems, biological systems (animals, plants), acclimatisation, isolation, health evaluation.
• Test and Reference Items – receipt, handling, sampling, storage, characterisation, stability, homogeneity, batch retention.
• Standard Operating Procedures – availability, approval, deviations, historical file.
• Performance of the Study – study plan, study plan amendments, study plan deviations, conduct of the study, raw data recording, data changes, audit trails.
• Reporting of Study Results – final report content, QA statement, Study Director signature, amendments.
• Storage and Retention of Records and Materials – archives, retention periods, indexing, access control.
• Multi‑Site Study Management – Principal Investigator role, communication, master schedule, study plan for multi‑site studies, delegation of phases.
• Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure.

The program is designed for internal auditing only and does not qualify individuals for inspections by the national GLP compliance monitoring authority.

OBJECTIVES

Upon completion of this program, the participant will be able to perform the following tasks.

• Interpret and apply all OECD Principles of GLP to single‑site and multi‑site nonclinical laboratory studies.
• Understand and apply the seven quality management principles in the context of GLP.
• Plan, manage, and execute internal audits in full accordance with auditing guidelines.
• Develop audit checklists, sampling plans, and audit protocols tailored to OECD GLP requirements.
• Collect objective evidence through interviews, observation, and document review.
• Identify and classify non‑conformities as major, minor, or observation with clear justification.
• Write non‑conformity reports that are factual, complete, and actionable.
• Prepare and distribute audit reports to appropriate management levels.
• Notify management of critical findings using escalation procedures.
• Track CAPA using a formal CAPA tracking log with status codes.
• Verify the effectiveness of corrective and preventive actions.
• Close an audit properly with a closure memo and management acknowledgment.
• Contribute audit results to management review and continual improvement.
• Understand the unique requirements of multi‑site studies, including Principal Investigator delegation, communication, and master schedule management.

TARGET AUDIENCE

This program is specifically designed for personnel working in nonclinical laboratory testing facilities that conduct studies in accordance with OECD Principles of GLP, including both single‑site and multi‑site studies. Typical roles include the following.

Quality Assurance Personnel – responsible for independent monitoring of studies, conducting inspections, and assuring GLP compliance.

Internal Auditors – both existing and prospective, who need formal training on OECD GLP requirements and audit techniques.

Study Directors – have overall responsibility for the technical conduct of studies and need to understand how their studies will be audited.

Principal Investigators – responsible for delegated phases of multi‑site studies and need to understand their compliance obligations.

Test Facility Management – responsible for appointing Study Directors, assuring resources, and ensuring GLP compliance.

Archivists – manage storage and retrieval of study plans, raw data, specimens, and final reports.

Laboratory Supervisors – oversee test systems, test article handling, or analytical procedures.

Sponsor Representatives – commission and support nonclinical studies and need to understand testing facility compliance.

Test Site Management – responsible for phases of multi‑site studies conducted at remote locations.

The prerequisites for enrolment include completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience. Participants should have at least six months of experience in a nonclinical laboratory testing facility. Basic computer skills using Excel and Word are also required.

CERTIFICATION 

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.