Validation is documented evidence that a process, method, cleaning procedure or computerised system consistently produces a result meeting its predetermined acceptance criteria.
Validation is documented evidence that a process, method, cleaning procedure or computerised system consistently produces a result meeting its predetermined acceptance criteria.
Plain-English explanation, then the primary regulation it comes from.
The distinction from qualification is the one to get right first, because procedures that blur it produce confused documents. You qualify things — equipment, utilities, facilities, systems. You validate activities — processes, analytical methods, cleaning procedures, computerised systems and their intended use. Qualification is usually a prerequisite for validation: you cannot validate a process running on unqualified equipment.
Validation goes wrong in two directions and both cost money. Under-validated, you cannot demonstrate the process does what you claim, and the gap surfaces at the worst possible moment. Over-validated, you have built a maintenance obligation that consumes the team every time anything changes — which in turn creates pressure to avoid changes that would genuinely improve the process. The scope should track the risk each system actually carries.
The validation master plan (VMP) is the document that holds the position together: what is in scope, the approach, responsibilities, acceptance criteria and the current status of each item. Its practical value is as a reconciliation tool. A VMP that has drifted from the equipment actually on the floor makes every document downstream of it unreliable, which is why reconciling it is the dullest and most productive place to start any validation review.
Validation is a state to be maintained, not a project to be completed. Change control is the mechanism: a change that affects a validated process must be assessed for whether revalidation is required. Where that link is weak, validation status decays silently until a transfer, a scale-up or an inspection exposes it.
Annex 15 — Qualification and Validation
ICH Q8, Q9 and Q12 for design space, risk and lifecycle management
Validation is a state to be maintained rather than a project to be completed, and its decay is silent until something forces the question.
“Does our validated state match the site as it is today?”
A validation master plan that has drifted from the equipment actually installed makes every document downstream of it unreliable. Change control is the mechanism that keeps validation current; where that link is weak, status decays quietly.
Reconcile the VMP against the floor, equipment by equipment. It is dull work and it is where the real gaps are.
GMP for Quality“Why does this surface at the worst possible time?”
It is paid during a transfer, a scale-up, an audit, or the introduction of a product that needs the equipment now. Work that would have been routine becomes a project on somebody else's timeline, frequently blocking a commercial commitment already made.
Treat validation status as a precondition for commercial commitments involving new products, sites or equipment, not as a downstream task.
GMP for CEO“Is under- or over-validation costing more?”
Under-validated, you cannot demonstrate the process does what you claim. Over-validated, you have built a maintenance obligation that consumes the team on every change — which then creates pressure to avoid improvements that would pay for themselves.
Scope validation to the risk each system actually carries. Uniform rigour is both expensive and, paradoxically, a way of under-controlling what matters.
GMP for CFO“What does this do to change and capacity?”
A heavy revalidation burden makes every process improvement expensive, so improvements stop being proposed. Qualification status that no longer matches installed equipment is also the finding most likely to surface within the first hours of a facility tour.
Risk-tier revalidation triggers so routine changes move and significant ones get genuine assessment.
GMP for COOLooking for a definition rather than an explanation? The GMP glossary covers the abbreviations in one line each.
If you want to know where your site actually stands against this, the readiness score covers seven quality-system domains in twenty questions, and takes about ten minutes.