Mandates cleanroom or controlled-environment production for specific packaging types to prevent particles or microbial contamination. Validation of Processes:
You must identify and control risks related to contamination and manufacturing errors. 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 | iso 15378 key pointspdf free
Have you seen customers demand ISO 15378 over ISO 9001 in RFQs yet? Let me know below. 👇 iso 15378 key pointspdf free