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21 CFR Part 58 - Good Laboratory Practice (GLP) for Auditors

What does 21 CFR Part 58 - Good Laboratory Practice (GLP) require of a Auditor?

Title 21 Code of Federal Regulations Part 58 establishes Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies supporting applications for research or marketing permits for FDA-regulated products. Under 21 CFR Part 58 - Good Laboratory Practice (GLP), which defines 25 controls, a Auditor's work is deciding which controls you own outright, which you share and which belong to another team, then holding the evidence for the first group.

Which 21 CFR Part 58 - Good Laboratory Practice (GLP) controls land on the Auditor

Internal Auditors assess whether compliance controls are operating effectively. They plan and execute audit engagements, evaluate evidence, report findings, and track remediation of identified gaps and nonconformities.

21 CFR Part 58 - Good Laboratory Practice (GLP) defines 25 controls across 7 domains that directly affect the Auditor role. Understanding which controls fall within your ownership, which are shared, and which are owned by other teams is the foundation of effective compliance management.

What a Auditor is accountable for under 21 CFR Part 58 - Good Laboratory Practice (GLP)

1

Planning and executing risk-based audit engagements against compliance frameworks

2

Evaluating control design and operating effectiveness through testing

3

Documenting findings, observations, and recommendations in audit reports

4

Tracking remediation actions and verifying closure of audit findings

5

Assessing organisational readiness for external audits and certifications

Where Auditors lose time on 21 CFR Part 58 - Good Laboratory Practice (GLP)

These are the most common obstacles Auditors face when managing 21 CFR Part 58 - Good Laboratory Practice (GLP) compliance, and how to address them:

Challenge 1

Efficiently testing controls across large, complex frameworks

Challenge 2

Accessing reliable evidence without disrupting business operations

Challenge 3

Mapping controls across multiple frameworks to avoid duplicate audit testing

Challenge 4

Keeping audit programmes current with regulatory and framework changes

Challenge 5

Communicating audit findings in a way that drives management action

A working order for a Auditor starting on 21 CFR Part 58 - Good Laboratory Practice (GLP)

1. Readiness Assessment

Take a 5-minute readiness assessment to identify your organisation's current gap profile against 21 CFR Part 58 - Good Laboratory Practice (GLP). Get a prioritised action plan tailored to your specific situation.

2. Cross-Framework Mapping

Use our platform to map 21 CFR Part 58 - Good Laboratory Practice (GLP) controls against other frameworks you already comply with. 21 CFR Part 58 - Good Laboratory Practice (GLP) maps to 182 other frameworks in our database.

3. Build Your Toolkit

Equip yourself with 21 CFR Part 58 - Good Laboratory Practice (GLP) toolkits, self-assessments, and implementation guides from our store. Resources designed specifically for Auditors managing compliance programmes.

4. Continuous Monitoring

Establish ongoing compliance monitoring using our platform's gap analysis tools. Track your maturity over time and demonstrate progress to stakeholders.

21 CFR Part 58 - Good Laboratory Practice (GLP) in your sector

21 CFR Part 58 - Good Laboratory Practice (GLP) for Healthcare→21 CFR Part 58 - Good Laboratory Practice (GLP) for Financial Services→21 CFR Part 58 - Good Laboratory Practice (GLP) for Technology→21 CFR Part 58 - Good Laboratory Practice (GLP) for Government→21 CFR Part 58 - Good Laboratory Practice (GLP) for Manufacturing→21 CFR Part 58 - Good Laboratory Practice (GLP) for Energy→21 CFR Part 58 - Good Laboratory Practice (GLP) for Retail→21 CFR Part 58 - Good Laboratory Practice (GLP) for Education→

Who else owns part of 21 CFR Part 58 - Good Laboratory Practice (GLP)

21 CFR Part 58 - Good Laboratory Practice (GLP) for CISOsView guide →21 CFR Part 58 - Good Laboratory Practice (GLP) for Compliance OfficersView guide →21 CFR Part 58 - Good Laboratory Practice (GLP) for Risk ManagersView guide →21 CFR Part 58 - Good Laboratory Practice (GLP) for IT DirectorsView guide →21 CFR Part 58 - Good Laboratory Practice (GLP) for DPOsView guide →

Questions Auditors ask about 21 CFR Part 58 - Good Laboratory Practice (GLP)

What does a Auditor need to know about 21 CFR Part 58 - Good Laboratory Practice (GLP)?
As a Auditor, your key responsibilities under 21 CFR Part 58 - Good Laboratory Practice (GLP) include planning and executing risk-based audit engagements against compliance frameworks and evaluating control design and operating effectiveness through testing. The framework contains 25 controls that fall within your area of responsibility. Understanding which controls you own versus which are shared with other teams is critical for effective implementation.
How does 21 CFR Part 58 - Good Laboratory Practice (GLP) affect the Auditor role?
21 CFR Part 58 - Good Laboratory Practice (GLP) directly impacts Auditors through planning and executing risk-based audit engagements against compliance frameworks, evaluating control design and operating effectiveness through testing, documenting findings, observations, and recommendations in audit reports. The framework provides structure that helps Auditors demonstrate due diligence and report compliance status to stakeholders.
What are the biggest 21 CFR Part 58 - Good Laboratory Practice (GLP) challenges for Auditors?
Common challenges include efficiently testing controls across large, complex frameworks; accessing reliable evidence without disrupting business operations; mapping controls across multiple frameworks to avoid duplicate audit testing. Using cross-framework mapping tools and automated evidence collection can significantly reduce these pain points.
How should a Auditor prepare for a 21 CFR Part 58 - Good Laboratory Practice (GLP) audit?
Start by conducting a readiness assessment to identify gaps. Then focus on documenting findings, observations, and recommendations in audit reports and tracking remediation actions and verifying closure of audit findings. Maintain a current evidence repository and ensure all control owners have documented their processes. Our readiness reports provide a prioritised action plan specific to your gap profile.
What tools help Auditors manage 21 CFR Part 58 - Good Laboratory Practice (GLP) compliance?
Effective 21 CFR Part 58 - Good Laboratory Practice (GLP) compliance management requires tools for gap analysis, control mapping, evidence collection, and reporting. Our compliance platform provides AI-powered gap analysis across 1,120 frameworks with 315K+ verified control-to-control mappings, helping Auditors identify overlapping requirements and reduce duplicate compliance effort.

Auditor: How ready is your organisation for 21 CFR Part 58 - Good Laboratory Practice (GLP)?

Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.

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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .