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ISO 15378

We Wish to Be Our Customers' Preferred Supplier
ISO Certification Ensures Safety and Reliability When Choosing Us

WHAT IS ISO 15378?

ISO 15378 is the internationally recognized quality management standard for primary packaging materials used in pharmaceutical applications.

It builds on ISO 9001 while incorporating Good Manufacturing Practice (GMP) requirements.  

The standard includes:

  • Batch-level traceability
  • Risk management and validation
  • Controlled production environments
  • Regulatory compliance

Our certification confirms systematic quality control and documented compliance throughout the entire supply chain.

COMPLIANCE IN PACKAGING

At ApodanNordic PharmaPackaging, we go beyond standard requirements.

Our internal Compliance in Packaging standards ensure we consistently raise expectations for documentation, quality assurance, and regulatory reliability.

Read more about our compliance in packaging here.

WHAT THIS MEANS FOR YOU?

When choosing ApodanNordic PharmaPackaging, you gain a supplier that:
  • Meets pharmaceutical industry requirements
  • Applies GMP principles throughout production and control
  • Understands critical product-contact requirements
  • Maintains quality systems supporting documentation
  • Ensures traceability, rinsed and sterilized packaging solutions where required
Want to know more? Read more here.


QUALITY YOU CAN RELY ON

Our ISO 15378 certification is your assurance that every solution meets the highest regulatory and industry expectations for pharmaceutical packaging safety and consistency.

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