Batch number (revision 4)
Old revision·20:01, 2 Sep 2024·COA_Colwyn
| Batch number | |
|---|---|
| Also called | Lot number, lot code |
| Assigned at | Production, or at fill, or at packing |
| Function | Links 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]
Assignment
[edit]Numbers may be assigned at several stages, and the stage determines what the number identifies. A number assigned at synthesis identifies a production campaign; at purification, a pool; at fill, a filling run; at packing, a shipment. These are not equivalent, and the same physical material can carry different identifiers under different schemes.[3]
Formats vary and no convention is universal. Common patterns encode a date, a product code and a sequence; others are opaque serial numbers. An encoded date is convenient but is not verification: a date embedded in an identifier is an assertion like any other field on a label.
References
- ^ ISO 9001:2015, Quality management systems — Requirements, clause 8.5.2.
- ^ United States Pharmacopeia, General Chapter <1503>, Quality Attributes of Synthetic Peptide Drug Substances.
- ^ International Council for Harmonisation, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (2000).