Primary packaging materials for medicinal products – EAGLE is the first ANAB accredited Certification Body worldwide to become accredited to ISO 15378.

Why ISO 15378 Certification?

Manufacturers of primary packaging materials for medicinal products benefit from ISO 15378 certification by:

• Globally recognized standard encompasses GMP requirements to primary packaging materials as well as ISO 9001 quality requirements;
• Enables companies to comply with legal requirements for pharmaceutical and medical device primary packaging materials;
• Mitigates risks of safety hazards and product contamination as well as ensures product efficiency and shelf life;
• Shows commitment to the health and well-being of those consuming medicinal products.

Contact us today to start the process.

Click here for EAGLE Registration’s ANAB Certificate of Accreditation

What is ISO 15378 Certification?

ISO 15378 certification is an internationally recognized standard that merges ISO 9001:2015 with the GMP requirements relevant to primary packaging material.  This holistic approach provides customer confidence in the safety and production of the manufacturers’ primary packaging materials.

Click here for more information about ISO 15378.

ISO 15378 Certification Client Testimonial

“ISO 15378 certification helps demonstrate to our pharmaceutical clients that we are complying with their specifications and regulatory requirements.  Berry Global believes in the value of an accredited audit because it ensures correct competencies and consistent interpretation of the standard.  The 15378 certification program aligns with our proven ISO 9001 Management System and by teaming up with EAGLE as our certification body, we have found this to be a value-added program.”

 –Berry Global Inc., Evansville, IN