| Testing at EFMHACA |
|
|
|
| Appearance |
USP |
3 |
Uses same ampoules as assay testing |
| Labelling |
USP |
| Assay |
USP |
Triplicate testing |
| Assay (spare) |
USP |
6 |
To allow repeat testing if first test found ampoules to be out of specification |
| Testing at MIPS |
|
|
|
| Investigative Testing (descriptive) |
In-house methods |
3 |
Testing to identify degradants/ impurities |
| Microbiological Testing |
|
|
|
| Validation (sterility) |
USP <71> |
8 |
Microbiological testing subcontracted to Chemical Analysis Ltd (Melbourne) |
| Sterility Testing Endotoxin Testing |
USP <71>
USP<85> |
5 |
| Total |
|
25 |
|