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

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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 should a Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] include?

A Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] should cover all inspection points required by FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) & OECD Principles of GLP (ENV/MC/CHEM(98)17). Key sections include: verification of compliance with FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) documentation requirements; condition assessment of all regulated equipment and processes; identification of deficiencies with corrective action assignments; inspector signature confirming observations; and a pass/fail compliance determination. The checklist must capture the inspector name, date, location, and permit or reference number. Each field should reference the specific regulatory clause it satisfies, so the completed record serves as documented evidence of due diligence for laboratory and chemical safety compliance purposes.

How often should a Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] be completed?

Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] inspections should be completed before production start; after any deviation or customer complaint; at each sanitation cycle. FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) specifies the minimum required frequency based on operational risk level and the regulated activity type. High-hazard operations typically require pre-shift verification, while lower-risk processes may allow weekly or monthly inspection cycles. The schedule must be documented in the organization's safety or quality management plan. Records must be retained for 2 years and made available to Quality Assurance Unit / Study Director and regulatory inspectors on request. Increasing frequency following any incident, near-miss, or regulatory change is a best practice regardless of the minimum required schedule.

What regulations apply to good laboratory practice (glp) compliance checklist [free pdf] compliance?

Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] compliance is primarily governed by FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) & OECD Principles of GLP (ENV/MC/CHEM(98)17). These standards establish the minimum inspection requirements, documentation format, record retention period, and corrective action procedures for laboratory and chemical safety in Laboratory operations. FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) provides the specific clause-level requirements that each inspection point must address. Additional state, local, or industry-specific requirements may supplement the federal baseline. Organizations operating in multiple jurisdictions must identify the most stringent applicable standard and design their inspection program to meet or exceed it, with documentation demonstrating which standard each inspection element satisfies.

Who should conduct a Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]?

Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] inspections must be conducted by Quality Assurance Unit / Study Director who have been trained on FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) requirements and the specific hazards, equipment, and processes covered by the checklist. FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) & OECD Principles of GLP (ENV/MC/CHEM(98)17) defines competency requirements including training documentation, qualification records, and where applicable, certification or licensure requirements. In some jurisdictions, certain inspection types require a third-party certified inspector or a licensed professional in addition to the internal compliance check. Inspectors must be independent enough from production pressures to make objective compliance determinations and escalate deficiencies without delay.

What are the consequences of failing a Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]?

Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] failures trigger a documented corrective action process under FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies). Minor deficiencies require a corrective action plan with assigned owner and target completion date. Major deficiencies may require operations to be suspended until the hazard is addressed. Regulatory enforcement consequences vary by jurisdiction and governing authority, and may include corrective action orders, suspension of operations, licence or permit action, and monetary penalties set by the enforcing agency. Beyond regulatory fines, inspection failures create documented evidence of known hazards that can be used in personal injury litigation, workers' compensation claims, and insurance coverage disputes. Prompt corrective action and re-inspection documentation are the primary mitigation tools.

What is a Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]?

A Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] is a standardized inspection form used by quality assurance unit / study director to ensure consistent laboratory operations. It contains 13 inspection points organized into 2 sections. FREE Good Laboratory Practice (GLP) compliance checklist PDF. FDA 21 CFR Part 58 and OECD GLP Principles compliant. 40+ GLP compliance verification points. Download FREE template.

How often should I use this laboratory checklist?

This checklist is designed to be completed per study phase. Regular use ensures compliance with FDA 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) and OECD Principles of GLP (ENV/MC/CHEM(98)17) and helps identify issues before they become problems.

Can I download this Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] as a PDF?

Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 13 fields across 2 sections and typically takes 30-45 minutes to complete.

What compliance standards does this checklist cover?

This checklist helps ensure 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). Following these standards protects your organization and ensures best practices.

How do I complete this laboratory inspection checklist?

Begin by completing the header fields for Test Facility Name, Inspection Date, QAU Inspector Name, and Study Number (if study inspection). Work through each of the 2 sections, marking items Yes or No as applicable. Add notes for any issues found. The entire process takes approximately 30 to 45 minutes.

What are the key sections in this laboratory checklist?

This laboratory checklist is organized into 2 key sections: Organization & Personnel, Records & Reporting. Each section contains specific inspection points that quality assurance unit / study director must verify. The structured layout ensures nothing is missed during laboratory inspections and makes the process efficient, typically taking 30-45 minutes to complete.

Who should use this Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF]?

This checklist is primarily designed for quality assurance unit / study director working in laboratory operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that laboratory standards are being met. Organizations of all sizes can benefit from using this Good Laboratory Practice (GLP) Compliance Checklist [FREE PDF] to maintain consistency and accountability.

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