If we done MLT or BET tests are additionally, should we have to complete the validation ??
What is the abbreviation of BET ?
bacterial endotoxin test
What do you mean with ‘additionally’?
Any test performed as a release test or as a validation test must be fully validated.
If we need to perform a test once, based on the customer requirement… at the moment we need perform the validation for that test ? Or wt else!
If the test is a release test, then yes.