GLP audit

What Is a GLP Audit and Why Does It Matter?

Good Laboratory Practice (GLP) audits play a critical role in ensuring the integrity, reliability, and regulatory acceptability of non-clinical study data. Whether supporting pharmaceutical development, chemicals registration, medical devices, or biotechnology products, GLP provides a framework for how studies are planned, performed, monitored, documented, and reported. Regulatory authorities rely on GLP-compliant data when making decisions about product safety, making effective auditing essential throughout the development lifecycle.

A GLP audit is a systematic and independent examination of a study, facility, process, or quality system to verify compliance with applicable GLP regulations and guidelines. In the U.S., these laboratories should be to be compliant with 21 CFR Part 58 Good Laboratory Practice and in the EU, similarly, laboratories are expected to fulfill Directive 2004/9/EC and Directive 2004/10/EC. Globally, OECD Principles of Good Laboratory Practice (GLP) is applied.

Audits may focus on a specific study, an individual laboratory, a contract research organisation (CRO), or an entire quality management system.

The objective is to confirm that study data are traceable, accurate, reproducible, and generated in accordance with approved protocols and standard operating procedures (SOPs). GLP audits also assess whether facilities maintain adequate documentation, training records, equipment controls, data management practices, and archiving procedures.

What Should be Included in a Good Laboratory Practice Audit Checklist?

A robust GLP audit checklist helps ensure a consistent and risk-based review of critical compliance areas. While requirements may vary by study type, common elements of a GLP inspection checklist include:

• Organisation and management responsibilities
• Personnel qualifications and training records
• Study protocols and amendments
• Standard operating procedures (SOPs)
• Equipment qualification, calibration, and maintenance
• Test and reference item management
• Sample handling and chain of custody
• Data recording, integrity, and traceability
• Quality Assurance (QA) oversight activities
• Study reports and raw data verification
• Record retention and archiving procedures

Regulatory inspection guidance from the OECD highlights the importance of reviewing both facility systems and individual studies to confirm that reported results accurately reflect the underlying raw data. Audit reports should clearly document observations, findings, and any deviations identified during the review.

What Incidents May Trigger a Request for a GLP Study Audit?

While routine audits form part of an effective quality system, regulators may also request targeted study audits when concerns arise regarding data reliability or GLP compliance. Potential triggers include:

• Studies conducted in countries outside recognised OECD Mutual Acceptance of Data (MAD) programmes
• Uncertainty regarding whether a facility was operating under an approved GLP compliance programme
• Significant GLP deviations recorded within the study
• Use of non-GLP laboratories for critical parts of a study
• Deficiencies in test article identification or characterisation
• Other departures that may affect the interpretation, integrity, or reliability of study results

These situations may prompt regulators to seek additional information or request a formal audit to assess whether the data remain suitable for regulatory decision-making.

How can Independent GLP Auditing Specialists Add Value?

As development programmes increasingly rely on multiple CROs, bioanalytical laboratories, and specialist testing partners, maintaining oversight across the supply chain becomes more challenging. Independent auditing specialists provide an objective assessment of both internal operations and external service providers.

Intertek’s third-party auditors bring experience across a broad range of facilities, technologies, and regulatory environments. This enables them to identify risks that may be overlooked by internal teams and benchmark practices against industry expectations and evolving regulatory requirements.

Our independent audits can also strengthen vendor qualification programmes, support due diligence activities, and provide sponsors with greater confidence in the quality and integrity of outsourced data. By creating transparency across the development network, organisations can proactively address compliance gaps before they become regulatory findings. Why choose Intertek as your GLP audit partner? We are an ISO 9001 accredited organization – quality is at the heart of everything we do. We possess 20 years of experience supporting the global healthcare sector with GLP audits with consistent quality and focus on detail over 5 continents. Our global network of auditors allows us to respond to your requests swiftly with travel costs and time minimised. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver.

We're pioneers in the delivery of shared GLP audits which brings greater efficiencies to scheduling an audit program costs. We can also provide the purchase of GLP audit reports which are available by request and agreement by the audit report sponsor.

Need to Prepare for Future GLP Inspections?

Our GLP auditors can support your internal reviews, vendor audits, risk assessments, and continuous quality improvement initiatives to help you maintain inspection readiness throughout the study lifecycle.

By combining robust quality systems with independent oversight, sponsors can strengthen data integrity, reduce regulatory risk, and ensure that non-clinical study results withstand scrutiny from health authorities worldwide. Contact us today to find out more about of flexibly GLP auditing solutions.