Reduces the need for multiple on-site audits by pharmaceutical customers. 📂 Accessing the Document
Understanding ISO 15378: Key Points for Pharmaceutical Packaging
ISO 15378:2017 is the specific standard that integrates into a Quality Management System for primary packaging materials. iso 15378 key pointspdf free
| Feature | ISO 9001:2015 | ISO 15378:2017 | | :--- | :--- | :--- | | Focus | Any product/service | Primary packaging for meds | | GMP integration | No | Yes (mandatory) | | Design control | Optional (clause 8.3) | Mandatory for packaging | | Cleanliness specs | Not defined | Defined in normative annexes | | Regulatory notification to customer | Not required | Required |
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The benefits of ISO 15378 certification include:
Understanding ISO 15378: Key Points for Pharmaceutical Packaging Example: ISO 15378 gap analysis checklist filetype:pdf The
Periodic self-checks to ensure the system is working. Accessing the Standard
