The underlying point is that start from the question: how many vials from this lot do I need to test to claim that the lot meets specification, and the answer depends on both the lot size and the acceptable risk.
A statement that "lot 20260412 complies with specifications" is meaningless without stating which vials from the lot were tested and how many there were.
If the entire lot failed qualification, a retest on a different vial is sometimes done, but reporting a retest result under the same lot number is misleading.
Sampling plans for pharmaceutical manufacturing are defined in ISO 2859 and ANSI Z1.4, and they are based on statistical sampling theory.
I would treat a "complies with" statement without sampling details as a claim rather than as evidence.
Assume segregation is possible, and design your sampling to catch it if it exists.
4This is the first explanation of that which has actually made sense to me. – Dr_Fatima_Belkacem 10 months ago 5Note that the label instructions differ between agents on precisely this point. – tobias_maartens 2 months ago add a comment