PeptidePedia The community reference

Batch number (revision 1)

Old revision·16:28, 7 Aug 2024·VerifyVesna

This is an old revision of this page, as it stood at 16:28, 7 Aug 2024, saved by VerifyVesna with the summary start article on the testing subject. It may differ substantially from the current revision, and any error it contains may since have been corrected.
Batch number
Also calledLot number, lot code
Assigned atProduction, or at fill, or at packing
FunctionLinks container to production and testing records
Topic infobox · conventions

A batch number — equivalently a lot number — is the identifier assigned to a quantity of material produced under uniform conditions. It appears on the container label and on the certificate of analysis, and it is the only thing connecting the two.[1]

The number itself carries no information about quality. Its function is referential: it allows a determination recorded against a lot to be applied to a container, and it allows a container to be traced to production records. A batch number with no records behind it is a string of characters.[2]

References

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