Advancing Injectable Drug Quality: Total Quality Management for Pharmaceutical Packaging

Quality in injectable drug packaging is not a single test result or a release certificate — it is a comprehensive, lifecycle-spanning management system that must govern every decision from raw material qualification to final product distribution, continuously adapting to evolving regulatory requirements, more sensitive drug formulations, and increasing sustainability expectations. This on-demand webinar, part of Datwyler's P.E.R.F.E.C.T.-ing the Pharmaceutical Packaging Selection Process series, provides pharmaceutical quality, packaging, and regulatory professionals with a structured Total Quality Management (TQM) framework applied specifically to parenteral packaging components. Topics covered include the foundational principles of TQM in pharmaceutical packaging — customer focus, process discipline, data-driven decision-making, and continuous improvement culture; controlled production process requirements spanning environmental monitoring, equipment maintenance, and stage-by-stage quality control from material selection through production; regulatory compliance standards anchoring Datwyler's quality system, including ISO 9001:2015, ISO 15378:2017, EU GMP Annex 1, Ph.Eur. 3.2.9, USP <381>, ISO 8871-3 particulate testing, ISO 11137 gamma sterilization validation, and ISO 17665 steam sterilization validation; risk mitigation strategies across the packaging material supply chain covering supplier selection and incoming inspection, critical process parameter control, change management and deviation handling, CAPA, environmental controls, and data integrity requirements; quality advancements addressing the key challenges of the pharmaceutical industry — minimal extractables from rubber components, low particulate levels, reduced silicone oil content, Annex 1 compliance, and supply chain robustness — as embodied in OmniFlex®, NeoFlex™, and UltraShield™ coated solutions; and the role of quality systems in promoting sustainability through lean manufacturing waste reduction, supplier engagement programs, automation-driven efficiency gains, and eco-friendly secondary packaging innovations.