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ISO 15378 Materials for the primary packaging of medication

ISO 15378 Materials for the primary packaging of medication

ISO 15378 Materials for the primary packaging of medication

Guarantee of quality and safety in primary packaging materials for medicinal products. The certification requirements, in compliance with ISO 15378, are intended for manufacturers of primary pharmaceutical packaging. The quality management system requirements to be met, based on good manufacturing practices (GMP), contribute to the quality of primary pharmaceutical packaging. Its advantages include: guaranteed compliance of the organisation with Good Manufacturing Practices under the ISO 15378 Standard; cost saving by reducing the number of audits carried out by pharmaceutical laboratories; it improves management, planning, organisation and control levels; ensures maximum quality and safety of primary pharmaceutical packaging; access to new markets by certification under an internationally recognised standard.

This certification can be integrated with the ISO 9001 management system.
Once the audit process has been passed, your organisation receives: a report with all audit process findings; the AENOR Certificate of compliance with ISO 15378.