The batch traceability process

The chain, stage by stage

Each stage generates a record that references the stage before it. The chain is only as strong as its weakest link, so the identifiers carry forward unbroken rather than being re-keyed at each step.

1. 01Raw material receiptIncoming reagents are logged with supplier identifiers and their own documentation.
2. 02Synthesis campaignThe campaign record references the raw material entries used.
3. 03Purification and poolingFraction analysis and pooling are recorded; the lot number is assigned here.
4. 04AnalysisIn-house and independent results are filed against the lot number.
5. 05Fill and labellingUnit counts, labels and the fill sequence are reconciled to the lot.
6. 06Storage and dispatchStorage conditions and the dispatch record close the internal chain.

Identifiers that carry through

Three identifiers do the work: the campaign reference, the lot number and the certificate reference. Every document in the chain carries at least one of them, and the lot number appears on the physical vial so the chain reaches into your freezer.

Retention

Lot records and retained samples are held after a lot is exhausted, so that a question raised long after the last vial shipped can still be answered against the original documentation and material.