Primary Packaging Materials for Medicinal Products
International standard for quality management systems specific to primary packaging materials used in pharmaceutical products.
ISO 15378 is a GMP (Good Manufacturing Practice) standard that specifies requirements for a quality management system specific to the manufacture of primary packaging materials for medicinal products. It combines the quality management principles of ISO 9001 with the specific GMP requirements applicable to pharmaceutical packaging. The standard ensures that packaging materials are consistently produced and controlled to meet the quality standards appropriate for their intended use in contact with medicinal products.
This page summarises ISO 15378 (current published edition). Always confirm the detail against the published document.