James Rigney

Manager, Quality North America

January 31, 2017

West Obtains ISO 15378 Certification in North America

In 2016, West reached another quality milestone -- ISO 15378 (Primary Packaging Materials for Medicinal Products) certification for manufacturing facilities in North America. These facilities now join the already-certified facilities in Europe and Asia Pacific regions.
Products certified are rubber stoppers, rubber plungers, and seals (aluminum and plastic). ISO 15378 specifies requirements for the design, manufacture, and supply of primary packaging materials for medicinal products (i.e., materials used in pharmaceutical packaging that have direct contact with the product). ISO 15378 comprises two individual standards: ISO 9001 (West approved in 2009) and Current Good Manufacturing Practice (in the US: 21 CFR 210 and 211 for Drugs, and 21 CFR 820 for medical devices). With this certification, West customers worldwide can have an even higher level of confidence in the quality of West manufacturing and in the quality of West products.

ISO 15378 can be found here.