ISO 15378 – Medicinal Product Packaging

ISO 15378:2006 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products (which consistently meet customer requirements, including regulatory requirements and other standards applicable to primary packaging materials).

The title of ISO 15378 is Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001:2000, with Reference to Good Manufacturing Practice (GMP).

ISO 15378:2006 is an application standard for the design, manufacture, and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.