The GLP Audit Checklist: What Auditors (and Inspectors) Actually Look For

Whether it's your QA unit, an outside consultant, or a regulator at the door, GLP audits orbit the same checkpoints. Here's the list — use it before they do.

The checklist

1. QA independence

Is the QA unit organizationally separate from study conduct? Do QA auditors sign off on protocols and reports without reporting to the people they audit? Independence on paper isn't independence in practice — inspectors interview.

2. SOPs: written, approved, followed

Are SOPs current, approved, and accessible at the bench? Do people actually follow them? The classic finding: a beautiful SOP nobody opened.

3. Personnel and training

CVs, job descriptions, training records for everyone touching the study. New hire did the pipetting? Show the training record.

4. Protocol compliance

Signed protocol before study start; amendments documented and approved; deviations recorded with impact assessment. Undocumented deviations are findings.

5. Equipment and facilities

Qualification, calibration, and maintenance records current. Equipment used outside its qualified state invalidates the data it produced.

6. Data integrity

ALCOA+ records, audit trails on computerized systems, controlled access. Shared logins and editable spreadsheets are red flags.

7. Test articles and specimens

Characterization, handling, storage, chain of custody, and disposition records. “We think that's the right vial” is a finding.

8. Archives

Secure, access-controlled, environmentally appropriate storage for raw data, specimens, and reports — with retrieval that actually works.

How to use this list

Run it as an internal self-assessment quarterly; bring in an independent auditor annually or before any inspection. Our readiness quiz scores these ten areas in two minutes — then get a scoped audit quote for the gaps it finds.

Related guides

• What Is GLP? Good Laboratory Practice Explained Without the Jargon
• How to Choose a GLP Consultant: 9 Questions Before You Sign