Perform System Suitability Tests Before Each HPLC Run for GMP Compliance

Always Perform HPLC System Suitability Tests Before Sample Analysis

Remember: System suitability testing must be performed before each HPLC run to confirm instrument performance and ensure GMP-compliant analytical results.

Why This Matters in GMP

High-Performance Liquid Chromatography (HPLC) is a critical analytical technique used in drug substance and product testing. System suitability tests—such as resolution, tailing factor, theoretical plates, and repeatability—ensure the system is performing within validated parameters before sample analysis begins. Skipping this step can lead to inaccurate data, invalid results, or false OOS findings. GMP requires that every test be traceable, reproducible, and scientifically justified. System suitability ensures confidence in results and safeguards against analytical error.

Also Read: Document Utility Failure Impacts on Products to Maintain GMP Traceability

Regulatory and Compliance Implications

FDA 21 CFR Part 211.160 & 211.165 require scientifically sound procedures and complete data for laboratory tests. EU GMP Chapter 6 and Annex 15 emphasize validated analytical methods with routine performance checks. WHO GMP and Schedule M require analytical systems to be verified for performance before each use. Auditors routinely review chromatograms, system suitability results, and analyst logbooks. Missing or failed suitability tests before HPLC runs are considered critical data integrity breaches and may invalidate the entire batch analysis.

Implementation Best Practices

Include

system suitability parameters in every HPLC test method and SOP.

Run the system suitability solution before each batch and document results electronically or in logbooks.

Ensure acceptance criteria are met before injecting any sample or standard.

Investigate and document failures immediately, and do not proceed until resolved.

Retain all chromatograms, audit trails, and suitability data for QA review and audits.

Regulatory References

FDA 21 CFR Part 211.160 & 211.165 – Laboratory Controls and Specifications
EU GMP Chapter 6 & Annex 15 – Laboratory Equipment and Validation
WHO GMP – Analytical Testing and Method Verification
Schedule M – HPLC System Checks and Validation Requirements