ISO 15378

ISO 15378 is International Standard for Primary Packaging Materials for Medicinal Products – Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of the direct product contact. The application of GMP for pharmaceutical packaging materials should ensure that these materials meet the needs and requirements of the pharmaceutical industry.

A key objective of this International Standard is to define harmonized primary packaging material requirements. It includes some particular requirements for primary packaging materials, which are derived from Good Manufacturing Practices for the production, control, etc. of medicinal products.