For Irradiated products, the manufacturer keeps the ultimate responsibility for his product. Irradiator is only responsible for dose delivery under validated plant parameters. Responsibilities are normally defined as follows:
| Topic | Irradiator | Manufacturer |
|---|---|---|
| Definition of the dose range | ✔ | |
| Validation of the dose definition | ✔ | |
| Validation of the dose suitability | ✔ | |
| Microbiological validation | ✔ | |
| Treatment SOP | ✔ | |
| Irradiator Commissioning | ✔ | |
| Definition of the loading pattern | ✔ | |
| Assurance of the loading pattern | ✔ | |
| Dosimetry | ✔ | |
| Release of the Final product | ✔ | |
| Stability tests | ✔ | |
| Packaging | ✔ | |
| Responsibility for transports | ✔ | |
| Sterility | ✔ |