ISO 15378:2017
Primary Packaging Materials for Medicinal Products
For businesses producing and supplying primary packaging materials for medicinal products.
ClassISO 9001 sector application
Edition2017
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.
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.
What does it 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.
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