Lot traceability (revision 7)
Old revision·20:53, 15 Sep 2024·OralSemaOswin
| Lot traceability | |
|---|---|
| Unit | The lot, or batch |
| Carrier of the link | The batch number |
| Broken by | Repackaging without record transfer |
| Topic infobox · conventions | |
Lot traceability is the property of a supply chain in which any given container can be linked back to the batch of material it was filled from, and forward from that batch to every container filled from it. It is what makes a certificate of analysis mean anything: a certificate describes a lot, and without traceability there is no established relationship between the lot it describes and the vial in hand.[1]
The link is carried by the batch number and is only as strong as the weakest transfer in the chain. Every point at which material changes container, changes hands, or is combined with other material is a point at which the link can be preserved by record-keeping or lost by its absence.[2]
Traceability is a documentary property, not an analytical one. No amount of testing on a vial establishes which lot it came from; that is established, or not, by records.
What a lot is
[edit]A lot, or batch, is a quantity of material produced in a single process run under conditions intended to be uniform throughout. Uniformity is the point: it is the assumption that licenses extending a determination made on a sample to the whole quantity.[1]
The assumption is not automatic. A synthesis run purified in several chromatographic fractions may be homogenised into one lot or held as several; a lot filled over a long period may not be uniform in fill mass; and a "lot" assembled by combining material from separate runs is a lot by declaration rather than by production.