Pharma Quality System

  Published by: Pharma Quality System Editorial Team • Editorial basis: FDA CGMP Laboratory Controls, ICH Q2(R2), ICH Q14, USP <621>, Health Canada GUI-0001, and recent FDA enforcement examples Last reviewed: September 4, 2026 HPLC • PHARMACEUTICAL QC • FDA • ICH Q2(R2) • USP <621> • HEALTH CANADA High-performance liquid chromatography (HPLC) is one of the most important analytical technologies used in pharmaceutical quality control. But reliable HPLC testing depends on far more than producing a clean chromatogram: the method must be fit for purpose, the system must be suitable, the sample and standard must be controlled, the electronic data must remain complete, and every reported result must be scientifically defensible. Quick answer HPLC separates components of a liquid sample because different compounds interact differently with a stationary phase inside the column and a flowing mobile phase . In pharmaceutical QC, HPLC may be used for assay, i...

  Published by: Pharma Quality System Editorial Team • Editorial basis: FDA laboratory controls, USP <621> Chromatography, Health Canada quality guidance, and ICH Q2(R2)/Q14 • Last reviewed: September 2026 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. Practice SST on the ...