Accepted answer
Batch testing establishes what can be claimed about the lot as a whole, and the sample size determines how much you can actually claim.
The statistical foundation here is well-established, which is why sampling plans from decades ago are still valid.
Stratified sampling — testing one vial from the top, one from the middle, and one from the bottom of a shipment — is cheap insurance against segregation.
Sampling plans for pharmaceutical manufacturing are defined in ISO 2859 and ANSI Z1.4, and they are based on statistical sampling theory.
Worth noting that thermal excursions during shipping affect different vials differently, so the lot may not be homogeneous even if it left the factory that way.
The practical summary: a lot number without a sampling statement is a lot number without meaning.
8Any reason this would differ for a longer peptide? – marta_okonkwo 7 months ago add a comment