GLP Audits

Thorough GLP Audit Services for Regulatory Compliance

Good Laboratory Practice (GLP) compliance is essential for non-clinical safety studies submitted to regulatory authorities. Our GLP audit services cover facility qualification, study-level audits, and regulatory gap analyses aligned with OECD GLP Principles and 21 CFR Part 58.

We help laboratories achieve and maintain GLP compliance through systematic audits, gap assessments, and practical corrective action guidance — protecting your study data integrity and regulatory submissions.

GLP Audits

What's Included in GLP Audits

Qualification of GLP Facilities

  • Pre-study site qualification
  • Facility inspections & assessments
  • GLP principles and SOPs review
  • Data Integrity & Traceability checks

GAP Analysis (21 CFR Part 58)

  • 21 CFR Part 58 compliance review
  • SOP coverage assessment
  • Lab personnel qualification verification
  • Facility & equipment verification

Study Protocol / Report Audits

  • Document completeness review
  • Raw data verification
  • Personnel training assessment
  • Equipment calibration verification
  • Sample tracking & QAU reviews
  • Final report compliance check

Process / Data Audits

  • Process analysis & optimisation
  • Risk-based facility maintenance
  • Data integrity verification
  • Audit trail review

GLP Regulatory Frameworks

21 CFR Part 58

FDA Good Laboratory Practice regulations for non-clinical laboratory studies in the United States.

OECD GLP Principles

International OECD Principles of Good Laboratory Practice adopted by regulatory bodies worldwide.

EU GLP Directive

European Union GLP Directive 2004/10/EC and national implementing regulations across member states.

Ready to Schedule Your GLP Audit?

Our GLP specialists will ensure your laboratory meets all applicable regulatory standards.

Request an Audit