Requalification
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.
The re-execution of qualification activities — typically OQ and/or PQ elements — on equipment, a facility, or a utility that is already qualified, performed at a defined interval, after a significant change, following an extended shutdown, or when a periodic review indicates drift, to confirm the system still performs within its qualified state.
Requalification is not a full repeat of the original qualification campaign from scratch; its scope is scaled to what actually needs re-verification. A scheduled requalification on a fixed interval revisits the same critical parameters checked during the original OQ/PQ. A change-driven requalification, by contrast, is scoped to whatever the change control record and its impact assessment identify as affected — a relocated piece of equipment, a modified utility, or a system that has sat idle long enough to raise doubt about its state.
Because requalification exists to answer the question “is this still what we originally qualified,” its acceptance criteria are usually the same criteria used the first time, unless the underlying process or specification has itself changed.
- —Re-executes qualification elements on an already-qualified system, not a full re-qualification from zero
- —Common triggers: scheduled interval, change control output, adverse deviation trend, relocation or major repair, extended idle period
- —Scope is determined by a documented impact assessment, not applied uniformly
- —Acceptance criteria generally mirror the original qualification unless the process/spec has changed
EU GMP Annex 15; FDA Process Validation: General Principles and Practices (2011)
Frequently asked questions
What is Requalification?
The re-execution of qualification activities — typically OQ and/or PQ elements — on equipment, a facility, or a utility that is already qualified, performed at a defined interval, after a significant change, following an extended shutdown, or when a periodic review indicates drift, to confirm the system still performs within its qualified state.
Which regulations cover Requalification?
EU GMP Annex 15; FDA Process Validation: General Principles and Practices (2011)