It all begun when we were daily producing radiopharmaceuticals at more than 30 production sites around the globe.
Every time just in time.
Everything that could go wrong went wrong and so we disappointed many patients and doctors because we could not deliver the product.
It is not the operator who fails … it is the system that allows the operator to fail.An experienced GMP auditor
But whos fault was it? Definitely not the operators who were working in a challenging environment and who were given too complex processes with too many tasks where each single one could cause the manufacturing to fail. And having learned this lesson for many years we started to seek for a solution.
A solution that goes beyond just more SOPs, more training, more documentation.