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Lot traceability in practice

Traceability is a records problem before it is a supplier problem. What to capture on receipt so that a result eighteen months from now can still be tied to a batch.

Written byNorthlake Bio Technical DocumentationScientific reviewReview pendingPublishedUpdatedReading time6 minutes

Traceability fails quietly. It fails at the moment a container is decanted into an unlabelled tube, or when a batch is reordered and the new material is added to a shelf position that still carries the old label. Neither event produces an error at the time; both make it impossible to reconstruct, later, which material produced which result.

Capture at receipt, not at use

The single highest-value habit is recording the lot number at the point of receipt, in the same system that will later hold the experimental record. By the time material is being used, the container may already be a secondary one.

  • Catalog number and lot number, transcribed from the container rather than from the packing note.
  • Date of receipt and the condition on arrival, including whether cold-chain packaging was still cold.
  • Where the certificate for that lot is stored, or the identifier that retrieves it.
  • The storage location the material was placed into.

Secondary containers inherit the lot, or they inherit nothing

Any container that material is transferred into needs the lot number on it. A label carrying only the compound name is a label that will be ambiguous the first time a second lot enters the laboratory. Where container size makes a full label impractical, an internal identifier that resolves to the lot is adequate — the requirement is that the chain can be walked backwards, not that every label is complete on its own.

Retention outlives the material

Certificates should be retained for as long as any result derived from that material might be examined, which is usually considerably longer than the material itself lasts. Retention periods are set by the institution's records policy, by the funder, or by the regulatory framework the work sits under, and are typically measured in years after publication or submission rather than after consumption of the vial.

A practical test

Pick a result from twelve months ago at random and try to identify the lot of every material that contributed to it, using only your records. Whatever step makes that difficult is the step to fix.

References

  1. ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratoriesInternational Organization for Standardization
  2. ISO 9001:2015 — Quality management systems — RequirementsInternational Organization for Standardization

References are cited as the standards and guidance this note is written against. Citing a standard is not a claim of conformance to it.

Scope

This note covers documentation, procurement, storage, and analytical practice for laboratory and manufacturing materials. It is not guidance for preparing or using any material in a person or an animal, and nothing in this catalog is supplied for that purpose.

More on documentation

  • How to read a certificate of analysis

    A certificate of analysis is an evidentiary document about one batch. This is what each section means, and which fields decide whether it is usable.