Second-Person Verification
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
An independent, documented check by a second qualified individual, performed at or close to the time a critical step is carried out, confirming that what was actually done matches what has been recorded — for example, witnessing and initialling a critical weighing — distinct from a later review of the completed record by the quality unit.
Second-person verification (sometimes called a peer check or witnessed step) is a real-time control: a second trained person independently observes or confirms a critical action — a raw-material weigh, a line clearance, a critical calculation — and signs or initials to that effect close to when it happened.
It is distinct from quality unit review of the finished batch record, which happens later and checks the paperwork for completeness and correctness rather than directly witnessing the action. Second-person verification catches an error or a data integrity gap at the moment it would otherwise occur, before it becomes embedded in the record.
The step being verified should be identified through risk assessment rather than applied uniformly to every action, and the verifier must be independent enough — not the same person performing the step, and appropriately trained — for the check to have real value.
- —A real-time, independent check by a second person, not a later paperwork review
- —Targeted at critical steps identified by risk assessment
- —Verifier must be independent of, and separate from, the person performing the step
- —Complements, rather than replaces, quality unit review of the completed record
EU GMP Chapter 6 (Quality Control) and Chapter 4 (Documentation); PIC/S GMP Guide
Frequently asked questions
What is Second-Person Verification?
An independent, documented check by a second qualified individual, performed at or close to the time a critical step is carried out, confirming that what was actually done matches what has been recorded — for example, witnessing and initialling a critical weighing — distinct from a later review of the completed record by the quality unit.
Which regulations cover Second-Person Verification?
EU GMP Chapter 6 (Quality Control) and Chapter 4 (Documentation); PIC/S GMP Guide