GLP inspections and study audits are conducted by national GLP monitoring authorities to verify that test facilities comply with the OECD Principles of Good Laboratory Practice and applicable national regulations. These assessments ensure that studies submitted to regulatory agencies are conducted with adequate quality assurance and data integrity. Inspections may be routine, for-cause, or part of a product-specific data review.

Inspection Types

Facility inspections evaluate the overall GLP compliance of a test facility, covering personnel, facilities, equipment, SOPs, training programs, and the Quality Assurance Unit (QAU) . Study audits are detailed examinations of a specific study, tracing data from raw observations through to the final report to verify accuracy and compliance. Both types of assessment may be announced or unannounced.

Preparation

Preparation for inspections includes maintaining current and complete documentation, ensuring that training records and SOPs are up to date, and conducting internal self-inspections to identify and correct deficiencies. Facilities should designate an inspection coordinator and prepare briefing materials that summarize facility operations and study activities. Mock inspections help personnel become comfortable with the process.

Conduct of Inspections

An inspection typically begins with an opening meeting where the inspectors present the scope and objectives, followed by a facility tour and document review. Inspectors examine facility conditions, personnel qualifications, equipment calibration records, and the QAU’s inspection documentation. The inspection concludes with a closing meeting where preliminary findings are discussed.

Common Findings

Common inspection findings include incomplete or insufficient training records, inadequate SOPs, poor data integrity practices, insufficient environmental monitoring, and deficiencies in equipment calibration or maintenance. Each finding is documented in an inspection report with a classification of critical, major, or minor based on its potential impact on data integrity. Facilities must respond with corrective and preventive action plans within specified timelines.

Conclusion

Inspections and audits are integral to the GLP compliance system, providing regulatory oversight that protects public health. Proactive preparation, a robust quality system, and a culture of continuous improvement help facilities achieve successful inspection outcomes. Viewing inspections as opportunities for improvement rather than burdens strengthens overall quality management.