Accepted answer
Worth being precise here: sampling plans exist precisely because testing everything is expensive, and they define the statistical relationship between sample size and lot-wide inference.
Acceptance Sampling by Attributes defines the number of samples you need from a lot to claim a specified quality level at a specified risk — it is in ANSI standard Z1.4.
More usefully, if you have reason to suspect inhomogeneity — different appearance in different vials, or a long or warm shipment — testing more vials is the diagnostic move.
Lyophilised peptide homogeneity studies show that vial-to-vial variation is usually small but occasionally large, depending on the distribution in the freeze-dryer.
The caveat is that sampling is a trade-off between cost and confidence, and neither test nor assumption is cost-free.
The practical summary: a lot number without a sampling statement is a lot number without meaning.
edited 9 Aug 2026 by fibre_or_fragment — reworded for clarity after a comment
8The timing signature is the useful part. Everything else is confounded. – tyndall_haze 42 days ago add a comment