When a pharmaceutical manufacturer is evaluating a new closure supplier, ISO 15378 is the first certificate they ask for. It is the application of ISO 9001 quality management principles specifically to the manufacture of primary packaging materials — the materials that directly contact the drug product.
ISO 15378 covers risk management, cleanroom requirements, material traceability, and validated processes. For a closure manufacturer, it means your quality system must address contamination control, dimensional consistency, and batch-level traceability — all documented in a way that a pharma QA team can audit.
At Right Angle Pharmapack, we are actively working toward ISO 15378 certification to complement our existing ISO 9001:2015 and WHO-GMP credentials. Our production already incorporates the key elements: classified clean-room assembly, in-process QC, and batch documentation for every shipment.