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
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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.
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When any analytical test is to be performed on a finished product or intermediate it’s method has to be validated or verified for its suitability.If the test and analytical method is suggested by the customer, then the customer should provide its validation information. And then only its suitability in your laboratory should be verified with limited / partial validation such as ruggedness.
It depends on compandial or non compandial methods… verification must be required for any new tests. Also need to perform quality evaluation.