Can anyone please help: What is an acceptable time frame for testing of process validation samples?
Is 1 month to test blends (or at least sensitive tests like assays and related subs) and 3 months for finished product acceptable?
Is there any known requirements for how these type of samples should be treated?[/quote]
Process validation should be initiated on first three batches preferably, and all the critical control points must be evaluated very carefuly and if any observation and deviation occur, must be noted and rectify and incorporated in documents. there is no need for 1st month for assay and Cu and three months for other tests, if your process is carefully validated then there is no need to take extra samples and testing after that.