⇤ APPLICATIONS, ARTICLES & TECHNICAL NOTES

HPLC qualification for GMP-regulated labs

Qualification of HPLC Systems is one of the most common tasks in GMP-regulated laboratories. Several different regulatory guidelines and pharmacopeial standards offer frameworks for this, ranging from pure instructions to rigid quality standards to be checked and documented in regular intervals. HPLC pump flow rates are a critical process parameter (CPP) within these frameworks and due to the mechanical nature of pump operation and due to their continuous operation in high-throughput applications, pump parts are subject to wear and tear, requiring special attention when it comes to qualification, requalification, and performance verification during normal operation and after preventive or corrective maintenance.