Cross-Verify Certificate of Analysis (COA) With Raw Data for GMP Assurance

Always Cross-Verify COA Results With Original Raw Data

Remember: Relying solely on a Certificate of Analysis (COA) without raw data verification is not GMP compliant—cross-verification is essential.

Why This Matters in GMP

The Certificate of Analysis (COA) summarizes key quality attributes of materials or finished products. However, without verification against raw data—chromatograms, calculations, weights, and observations—its authenticity and accuracy remain unchecked. Accepting a COA at face value may expose the facility to falsified data, supplier negligence, or analytical errors. GMP requires traceability and validation of data used for quality decisions. Verifying raw data ensures that reported values are accurate, derived from validated methods, and meet specifications. It also supports root cause analysis in case of complaints or deviations.

Also Read: Never Use Trial Batches for Commercial Release Under GMP

Regulatory and Compliance Implications

FDA 21 CFR Part 211.194 mandates that laboratory test results be backed by raw data. WHO GMP and Schedule M emphasize the review of source data before batch disposition. EU GMP Annex 15 requires verification of third-party COAs during supplier qualification and material release. Regulatory auditors expect complete traceability from reported values to raw records. Failing to cross-verify COAs may lead to data integrity observations, especially when using outsourced testing or third-party vendors. QA must review original test data for all critical parameters before accepting results.

Implementation Best Practices

Establish SOPs requiring QA review of all analytical raw data corresponding to COA entries.
Maintain data review checklists for identity, assay, impurities, and microbial results.
Request raw data from vendors during material evaluation and audit third-party labs periodically.
Train staff to verify chromatograms, calculation sheets, and equipment logs alongside COAs.
Ensure that each COA file includes a reference to raw data location and reviewer initials.

Also Read: Ensuring GMP Compliance with FDA Standards in Pharma Supply Chains

Regulatory References

FDA 21 CFR Part 211.194 – Laboratory Records
EU GMP Annex 15 – Qualification and Validation
WHO GMP – Quality Control Documentation
Schedule M – Certificate of Analysis Verification