Pharma Quality System

  Published by: Pharma Quality System Editorial Team • Editorial basis: FDA Data Integrity guidance, FDA Part 11 guidance, CGMP laboratory controls, Health Canada GUI-0050 and GUI-0001 DATA INTEGRITY • 21 CFR PART 11 • HPLC/CDS • FDA • HEALTH CANADA Audit trail review is a key control for detecting unauthorized, unexplained or inappropriate changes to GMP electronic records. In pharmaceutical laboratories, it can reveal deleted injections, repeated analyses, altered integrations, method changes, sequence modifications and other events that may affect the reliability of reported results. Quick answer An audit trail is a secure computer-generated history that allows reconstruction of relevant electronic-record events. Audit trail review should be risk-based, documented and focused on GMP-relevant events . In HPLC/CDS environments, review should consider sequence changes, deleted or aborted injections, reintegration, reprocessing, method changes, user actions and ot...

  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...

  Published by: Pharma Quality System Editorial Team • Editorial basis: ICH Q2(R2), ICH Q14, FDA laboratory controls, and Health Canada ICH implementation ICH Q2(R2) • Q14 • HPLC • QC LABORATORY Analytical method validation demonstrates that an analytical procedure is fit for its intended purpose. Under ICH Q2(R2), validation is linked more explicitly with analytical procedure development, lifecycle knowledge, risk and the performance characteristics needed for the intended analytical use. Quick answer Analytical method validation is not a fixed checklist where every characteristic is always required. The design depends on the intended analytical purpose . Common characteristics include specificity/selectivity, accuracy, precision, response/linearity where appropriate, range, detection limit, quantitation limit and robustness. Current regulatory point: FDA finalized ICH Q2(R2) and Q14 in March 2024. Health Canada implemented Q2(R2) on October 17, 2025 and Q14...