Repackaging (revision 1)
Old revision·09:00, 30 Sep 2024·PrepHPLC_Pia
| Repackaging | |
|---|---|
| Operation | Transfer to a new container, or relabelling |
| Risk | Severed traceability |
| Mitigation | New record referencing the original lot |
| Topic infobox · conventions | |
Repackaging is the transfer of material from one container into another, or the relabelling of an existing container under a new identifier. It is a legitimate and common operation, and it is also the point at which lot traceability is most often lost.[1]
A repackager who assigns a new batch number without recording the original one has severed the link between the container and every determination ever made on the material. The resulting vial cannot be associated with any certificate, however genuine that certificate is.[2]
Why the record is the whole thing
[edit]Nothing about repackaged material is detectable by analysis. A repackaged peptide is the same molecule, and a determination on it returns the same numbers; what has changed is what is known about where it came from.[2]
| Practice | Effect on traceability |
|---|---|
| New identifier referencing the original lot | Preserved |
| New identifier, original recorded internally | Preserved if records are retrievable |
| New identifier, original not recorded | Severed |
| Original identifier retained | Preserved, but may misattribute the repackaging step |