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Lot traceability (revision 2)

Old revision·19:03, 24 Jul 2024·BlindSampleBrid

This is an old revision of this page, as it stood at 19:03, 24 Jul 2024, saved by BlindSampleBrid with the summary add the cross-link to the traceability article. It may differ substantially from the current revision, and any error it contains may since have been corrected.
Lot traceability
UnitThe lot, or batch
Carrier of the linkThe batch number
Broken byRepackaging 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]

References

  1. ^ ISO 9001:2015, Quality management systems — Requirements, clause 8.5.2 (identification and traceability).
  2. ^ United States Pharmacopeia, General Chapter <1503>, Quality Attributes of Synthetic Peptide Drug Substances.