ISO 15378:2017, including Amendment 1: Climate action changes
Primary Packaging Materials for Medicinal Products
ISO 15378 (2017) is an iso 9001 sector application: Primary Packaging Materials for Medicinal Products. An application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It combines the sector-specific application of ISO 9001:2015 with Good Manufacturing Practice (GMP) requirements. It applies to manufacturers and suppliers of product-contact pharmaceutical packaging such as bottles, closures, blisters and tubes.
- Class
- ISO 9001 sector application
- Edition
- 2017
- Related sectors
- 2
- Last verified
What is this standard?
An application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It combines the sector-specific application of ISO 9001:2015 with Good Manufacturing Practice (GMP) requirements.
What ISO 15378 does not replace
- It is not a standalone management system standard but a sector-specific application of ISO 9001.
- It does not substitute for a marketing authorisation or a GMP inspection.
Who is it for?
Manufacturers and suppliers of product-contact pharmaceutical packaging such as bottles, closures, blisters and tubes.
What triggers an assessment?
- Pharmaceutical packaging in direct product contact is manufactured.
- A pharmaceutical manufacturer customer wants GMP assurance.
- The supply role is critical for patient safety.
Official source
Amendment source
- Amendment 1: Climate action changes ↗ — Last verified:
Last verified:
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