Lot traceability (revision 14)
Old revision·22:20, 4 Jan 2025·GlossaryGleb
| Lot traceabilityQuality systems | |
|---|---|
Each transfer either preserves the link between vial and record, or breaks it. | |
| 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.
Because the definition is procedural rather than physical, the meaningful question about a lot number is what procedure assigned it. A number that identifies a synthesis campaign, a purification pool and a fill run supports a different inference from one assigned at the point of packing.[3]
Where the chain breaks
[edit]| Transfer | Link preserved by | Failure mode |
|---|---|---|
| Bulk to fill line | Fill record naming the bulk lot | Fill record not retained |
| Fill to labelling | Label carrying the lot | Generic label without lot |
| Supplier to distributor | Shipping record naming lots | Consolidated shipment, no lot detail |
| Distributor to buyer | Invoice or packing list | Lot omitted from paperwork |
| Any Repackaging | New record referencing the old lot | New lot number with no back-reference |
The last row is the most consequential. Repackaging into new containers with a newly assigned identifier and no back-reference severs the chain completely, and the resulting vial cannot be associated with any certificate however genuine that certificate is.[2]
See also
References
- ^ a b ISO 9001:2015, Quality management systems — Requirements, clause 8.5.2 (identification and traceability).
- ^ a b 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).