TGA is paid to protect the interests of Pfizer, Moderna, Novavax, AstraZeneca and all other Big Pharma and refuses to tell Taxpayers their Endotoxin Limit for a "Pass"
When robust in process controls were used as a reason for reducing final product testing for chemical products some years back it made sense.
Reducing final product testing when the process is biological and therefore cannot be adequately monitored or controlled is madness.
When robust in process controls were used as a reason for reducing final product testing for chemical products some years back it made sense.
Reducing final product testing when the process is biological and therefore cannot be adequately monitored or controlled is madness.