Short answer

Batch-specific traceability means a laboratory can demonstrate which material was ordered, which container was received, which sample was tested, which report applies, and who accepted or rejected it. The key is a stable identifier carried across the supplier record, vial label, COA, verification page, receiving log, and internal disposition.

Key facts

  • Traceability is the ability to show which material was ordered, received, tested and accepted.
  • A stable identifier must follow the batch from the supplier record to the vial label, the report and the receiving log.
  • A report for another batch of the same compound is not evidence for the batch in hand.
  • Verification means checking the report against the issuing laboratory's own record, not only reading the PDF.
  • Every discrepancy should be written down, resolved and kept with the batch file.

What batch-specific means

A batch, or lot, is material made in one run under the same conditions and tested as one unit. Batch-specific traceability means a laboratory can demonstrate which material was ordered, which container was received, which sample was tested, which report applies and who accepted or rejected the material.

The key is a stable identifier carried across the supplier record, the vial label, the certificate of analysis, the verification page, the receiving log and the internal disposition.

Common ways the chain breaks

Most failures are mundane. A supplier may re-use one report for several lots of the same compound. A batch code on the label may differ from the one on the report by a character, or a report may carry a product name without any lot at all. A vial may be re-labelled in transit. Reports can also be edited after issue, so that the visible text no longer matches the laboratory record.

A single mismatch does not prove misconduct, but it means the chain cannot be closed until it is resolved.

How to verify a report

Compare the task or report number, the verification key and the date on the report with the issuing laboratory's own record where one is offered. Check that the QR code or link goes to a page on the laboratory's domain and that the page shows the same sample, client and results. Keep the original file unchanged and add your own notes in a separate record.

The guide to verifying a third-party report lists the fields to compare.

What to do with a mismatch

Quarantine the affected material and write down what was found: the two codes, the dates and photographs of the label and the report. Ask the supplier in writing for the matching report, and keep the reply. If the supplier states that two codes describe the same lot, ask for the explanation on letterhead or in a signed note.

Release the material only when the chain is complete or when your own testing provides the evidence that was missing.

Keep a batch file

A batch file brings the pieces together: the order, the invoice, the report, the verification, photographs of the label, the receiving record, storage conditions, any in-house results and the disposition. The compound identity file template gives a layout that is easy to audit and easy to hand to a colleague.

Frequently asked questions

Is a COA for the same compound but a different lot acceptable?

It can be useful context, but it is not batch-specific evidence. Treat it as supporting information and ask for the report that matches the lot you received.

What if the supplier uses an internal batch code and the laboratory uses another?

That is acceptable only when the supplier provides a documented cross-reference that links both codes to the same material. Keep that cross-reference with the batch file.

How long should batch records be kept?

Keep them at least as long as the material or any data produced with it is in use, and longer if your quality system or funder requires it.

Can a photograph of the label serve as evidence?

Yes, as one link in the chain. Photograph the label together with the container and a note of the date, and store it with the receiving log.

Primary references

  1. FDA: Data Integrity and Compliance With Drug CGMP
  2. FDA: Pharmaceutical Quality Control Laboratories Inspection Guide

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