ISO 15378 - Primary Packaging Materials For Medicinal Products

The standard is applicative to the design, manufacture and supply of the primary packaging for medicinal products and it is intended to be suitable for any organization irrespective of its type, size or the products and services it provides.

Certified organisations can promote themselves as certificate holders in their promotional materials and can include the URS certification logo free of charge.

• It demonstrates quality, good manufacturing and safety controls for the primary packaging items within certified organizations, which are important for patient safety.
• In conjunction with ISO 9001:2015 it ensures the products meet the requirements of the pharmaceutical industries.
• It ensures brand protection.
• The standard is designed to help organizations identify, control and manage risks through the audit process.
• It ensures compliance with the statutory and regulatory requirements.
• Customer satisfaction is enhanced through the application of the QMS, including processes for continual improvement and conformity to customer prerequisites.