What are the Agency’s suggestions relating to in-procedure stratified sampling of completed dosage units? For example, Even though the CPG won't specifically mention concurrent validation for an API Briefly source, the Company would look at the use of concurrent validation when it is necessary to deal with a real shorter-offer circumstance, and
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be absolutely confirmed by subsequent inspection and check.” Put simply, once you can’t use process verification to verify your process is Operating as supposed.Concurrent validation should only be employed underneath exceptional situations where by the urgency of product or service availability is important. The choice needs to be carefully ev
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