Laboratory Audits for Peptide Testing

A laboratory audit evaluates whether systems, personnel, methods, equipment, and records support reliable results.

Audit scope

A focused audit may review:

• accreditation or compliance status
• organization and independence
• analyst qualifications
• method validation
• instrument qualification
• reference standards
• sample receipt
• chain of custody
• data integrity
• report issuance
• deviations and CAPA
• subcontracting
• record retention

Observe actual practice

Written procedures should be compared with how work is actually performed.

Data review

Auditors may trace a final COA back through sample receipt, instrument files, integration, calculations, review, and approval.

Findings

Findings should be categorized by risk and linked to corrective actions and effectiveness checks.

Frequently asked questions

Is accreditation enough to skip an audit?

Not always. Risk, scope, and business requirements may still justify an audit.

Should the laboratory disclose subcontracting?

Yes. The customer should know who performs each test.

Can remote audits be effective?

They can support review, but some risks may require on-site observation.

Why trace one result end to end?

It tests whether the system is reconstructable.

Key takeaways

A laboratory audit tests the reliability of the system behind the certificate. Method scope, data traceability, and actual practice matter more than appearance.

References

1. FDA. Data Integrity and Compliance With Drug CGMP: Questions and Answers.
2. OECD Principles of Good Laboratory Practice.
3. ISO/IEC 17025 overview.

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TSMS Labs educational disclaimer: For laboratory research and educational purposes only. Not for human consumption. This content is not medical, clinical, or regulatory advice.