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.
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.
More usefully, for a quantitative result like content, the acceptable range determines how many vials you need to test to establish the lot complies.
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.
edited 21 Apr 2026 by sian_llewellyn — tightened the wording; no substantive change
6The timing signature is the useful part. Everything else is confounded. – h_pergande 5 months ago add a comment