Q : We just start with validation for about 2 years & I am still new in this dept.
We have many types of machine like endless sealer machine (to seal pouch bag).
We validate IQ, OQ, PQ accordingly, but the thing is, OQ we test until 25 conditions (5temperature & 5 sealing time).Seal strength test show not achive spec for some extreme condition (too low/too high setting) .
How do we define "worst case testing"?
I received 1 observation asking "how do you define worst case testing"
What is the meaning of worst case testing?
Can someone help me?