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I think we need to validation for the new addition of Impurity only., through addendum
When all process of Formulation is same but change in source of API ( vendor change) then what parameters to be performed in re validation?
What is different between usp and usp-nf ?
Is cross validation and methods equivalency are the same
Sir which parameters performed in at the time of method transfer and is it any differences in acceptance cretirias inthe validation and method transfer same parameters is it acceptble?
Sir make a full video on method transfer
I think we need to validation for the new addition of Impurity only., through addendum
When all process of Formulation is same but change in source of API ( vendor change) then what parameters to be performed in re validation?
What is different between usp and usp-nf ?
Is cross validation and methods equivalency are the same
Sir which parameters performed in at the time of method transfer and is it any differences in acceptance cretirias inthe validation and method transfer same parameters is it acceptble?
Sir make a full video on method transfer