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Sample identification and laboratory traceability

Practical principles for unique sample identification, connecting receipt to analysis, managing aliquots and maintaining auditable laboratory records.

01A unique, neutral identifier

An internal identifier should be unique, readable and independent of assumptions about the result. Its structure may include year and sequence,…

02Identification from receipt to analysis

Sample identification should remain consistent across labels, receipt registers, preparation records, instrument sequences and final reports. Agreement of name and unique…

03Parent sample and aliquots

Each aliquot connects to the parent material, preparation method, quantity and location. Transfers between containers are recorded so an analytical result…

04Audit trail

Corrections preserve the original entry, reason, time and responsible person. Traceability allows work to be reconstructed without publishing operational codes. On…

01

A unique, neutral identifier

An internal identifier should be unique, readable and independent of assumptions about the result. Its structure may include year and sequence, but should not expose personal data or change when interpretation changes.

02

Identification from receipt to analysis

Sample identification should remain consistent across labels, receipt registers, preparation records, instrument sequences and final reports. Agreement of name and unique identifier allows every result to be connected to the material actually examined.

03

Parent sample and aliquots

Each aliquot connects to the parent material, preparation method, quantity and location. Transfers between containers are recorded so an analytical result can be traced to the material actually used.

04

Audit trail

Corrections preserve the original entry, reason, time and responsible person. Traceability allows work to be reconstructed without publishing operational codes. On the commercial website, analytical documentation can be available on request.

LABORATORY APPLICATION

Turning the principle into an auditable record

Define identifier format, issuance rules, label, location register and connection to instrument records. Check that exported files, handwritten notes and final reports use the same identifier. Codes are disclosed only when there is a lawful and operational reason.

01Identifier changing with the result
02Aliquot without parent linkage
03Correction erasing the original record

PRIMARY & OFFICIAL SOURCES

Sources and further reading

  1. 01WHO — Good storage and distribution practices↗
  2. 02EMA / ICH Q14 — Analytical procedure development↗

COMMON QUESTIONS

Questions specific to this topic

What is sample identification?

It is the consistent association of one unique identifier with the same material at every stage, from receipt and labelling through analysis and reporting.

What makes a good identifier?

It is unique, neutral, stable, readable and does not expose unnecessary personal data.

Should every aliquot have its own code?

When movements or analyses must be distinguished, yes, with clear linkage to the parent sample.

Must identifiers be public?

No. Internal traceability can be complete while documentation is supplied only to appropriate recipients.