Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]
This GLP compliance checklist verifies nonclinical laboratory studies meet FDA 21 CFR Part 58 Good Laboratory Practice regulations and OECD GLP Principles. Quality Assurance Units use this during phase inspections and study audits to document GLP compliance for studies supporting regulatory submissions.
- Industry: Laboratory
- Frequency: Per Study Phase
- Estimated Time: 30-45 minutes
- Role: Quality Assurance Unit / Study Director
- Total Items: 9
- Compliance: FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), OECD Principles of GLP (ENV/MC/CHEM(98)17), EPA 40 CFR Parts 160 and 792 (FIFRA and TSCA GLP), ICH E6(R2) (GCP - referenced for comparator principles)
Organization & Personnel
Verify GLP organizational and personnel requirements.
- Management statement of GLP commitment signed and current?
- Study director designated in writing before study start?
- QAU independent from study conduct and reports directly to management?
- Training records current for all personnel performing GLP functions?
Records & Reporting
Verify GLP recordkeeping and report requirements.
- Raw data retained securely with access controls?
- Study protocol approved and signed before study initiation?
- All protocol deviations documented and reviewed by study director?
- Final report signed by study director with GLP compliance statement?
- GLP compliance notes and findings
Related Laboratory Checklists
- Forensic Laboratory Quality Assurance Checklist [FREE PDF]
- Cleanroom Qualification & Monitoring Checklist [FREE PDF]
- ISO/IEC 17025 Laboratory Quality Management Checklist [FREE PDF]
- Pharmaceutical QC Laboratory Compliance Checklist [FREE PDF]
- Environmental Testing Laboratory QA/QC Checklist [FREE PDF]
- Nanotechnology Research Laboratory Safety Checklist [FREE PDF]
- Cryogenic/Liquid Nitrogen Safety Checklist [FREE PDF]
Related Quality Management Checklists
- ISO/IEC 17025 Laboratory Quality Management Checklist [FREE PDF] - FREE Download
- Forensic Laboratory Quality Assurance Checklist [FREE PDF] - FREE Download
- Cleanroom Qualification & Monitoring Checklist [FREE PDF] - FREE Download
Why Use This Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]?
This good laboratory practice (glp) compliance checklist [free pdf] helps laboratory teams maintain compliance and operational excellence. Designed for quality assurance unit / study director professionals, this checklist covers 9 critical inspection points across 2 sections. Recommended frequency: per study phase.
Ensures compliance with FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), OECD Principles of GLP (ENV/MC/CHEM(98)17), EPA 40 CFR Parts 160 and 792 (FIFRA and TSCA GLP), ICH E6(R2) (GCP - referenced for comparator principles). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] cover?
This checklist covers 9 inspection items across 2 sections: Organization & Personnel, Records & Reporting. It is designed for laboratory operations and compliance.
How often should this checklist be completed?
This checklist should be completed per study phase. Each completion takes approximately 30-45 minutes.
Who should use this Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]?
This checklist is designed for Quality Assurance Unit / Study Director professionals in the laboratory industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.