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ISO 15378: Good distribution practices for medications and active ingredients

ISO 15378: Good distribution practices for medications and active ingredients

Guarantee of quality and safety in the primary packaging of medication

The certification scheme complies with the standard ISO 15378 is intended for manufacturers of primary packaging for medicines. This certification scheme increases the quality of primary packaging for pharmaceuticals using a system for managing the quality of best distribution practices.

Benefits of being ISO 15378 certified

  • Guarantee that the organisation meets the Good Manufacturing Practices in accordance with standard ISO 15378
  • Cost savings due to reduced audits carried out by pharmaceutical laboratories
  • Improves the levels of management, planning, organisation and control.
  • Ensure the maximum quality and safety of primary packaging for pharmaceuticals
  • Access to new markets through certification of an internationally-renowned standard.

This certification can be integrated with the management system ISO 9001.

Once the audit is complete and successful, your organization receives a report with all the audit findings and the AENOR certificate of compliance with the standard ISO 15378.

AENOR Mark

AENOR Mark for Systems
UNE-EN ISO 15378

IQNetMANAGEMENT SYSTEM Mark

IQNet Mark
RECOGNIZED CERTIFICATION​