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Certification According to ISO 15378

Certification According to ISO 15378

Marketing Well-Packaged Pharmaceuticals

When it comes to pharmaceuticals, customers especially expect safe and sanitary packaging. We inspect your primary packaging materials for pharmaceutical products and certify their compliance with ISO 15378. This demonstrates the integrity of your quality management system – from packaging design to assembly.

Benefits at a Glance

With ISO 15378 certification by experts at TÜV Rheinland, you can:

  • Communicate your high standards of quality
  • Lower your risk of liability through documented safety standards
  • Boost confidence in the quality of your company
  • Improve your market position thanks to a certified quality management system
  • Benefit from our fast certification times and long-standing experience

The ISO 15378 Certification Process

Our experts certify primary packaging materials for pharmaceutical products in three steps:

1. Optional Preliminary Audit
During this preliminary evaluation, our auditors inspect your site and review your quality management documentation.

2. Initial Certification Audit

Phase 1:
We conduct an on-site audit or analyze all the required information to determine whether your quality management system complies with the standard.

Phase 2:
On-site, we then examine and evaluate how it is applied in practice and how effective it is.

3. Certificate
If your company meets all the criteria, we issue a certificate confirming compliance with the standard and and the integrity of your quality management system.

Standard ISO 15378 on Primary Packaging Materials

This standard is based on EN ISO 9001, an internationally recognized standard that defines requirements for quality management systems. ISO 15378 covers the full range of "good manufacturing practices" (GMP) used in the manufacture of primary packaging materials. In addition to EN ISO 9001, manufacturers must also comply with ISO 15378, which contains additoinal criteria related specifically to packaging materials.

These criteria include:

Batch monitoring and documentation

Controlled environmental conditions

Validations and qualification

Risk management

Did you know? Neither a decision on granting certification nor any change of the certificate status (e.g. maintaining, renewing, refusing, suspending, restoring or withdrawing certification as well as expanding or reducing the scope of certification) is made by a single person! We always apply the four-eyes principle: The evaluation of the audit team /product expert is followed by a separate review and decision.


Any questions? Would you like an individual, non-binding offer? Then write to us now. We will respond to your request as quickly as possible.

pdf Questionnaire for the preparation of an offer for medical products 181 KB Download
pdf General Terms & Conditions 62 KB Download
pdf Testing & Certification Regulations 120 KB Download


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