HPLC System Suitability in Pharma: Resolution, Tailing Factor, %RSD, Plates & FDA Expectations
Published by: Pharma Quality System Editorial Team • Editorial basis: FDA laboratory controls, USP <621> Chromatography, Health Canada quality guidance, and ICH Q2(R2) HPLC • USP <621> • FDA • HEALTH CANADA • QC LAB HPLC system suitability is the documented demonstration that the chromatographic system is capable of producing acceptable analytical performance for a specific procedure and run. It is not simply a retention-time check, and it is not a substitute for method validation. Quick answer Common HPLC system-suitability parameters include repeatability (%RSD), resolution, peak symmetry/tailing, system efficiency (theoretical plates), sensitivity and other method-specific criteria. The correct acceptance limits come from the approved analytical procedure, applicable monograph or scientifically justified protocol-there is no single universal set of limits for every HPLC method. Critical GMP point: FDA states that system suitability should us...