Preventive Maintenance
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.
A scheduled, documented program of inspection, servicing, and component replacement performed on equipment, utilities, and facility systems before failure occurs, intended to sustain a system’s qualified or validated state, minimize unplanned downtime, and prevent maintenance-driven deviations from GMP-critical performance during routine operation.
Preventive maintenance is planned rather than reactive: work orders are scheduled against a calendar or a usage counter, using manufacturer recommendations and the site’s own reliability history rather than waiting for a breakdown. For direct-impact equipment, the maintenance schedule is itself part of what keeps the system inside the boundaries the original qualification demonstrated.
A missed or overdue preventive-maintenance task on GMP-critical equipment is treated as a quality event in its own right, and a major maintenance intervention — replacing a critical component, for example — is typically routed through change control to assess whether it affects the system’s qualified state.
- —Scheduled and documented, performed before failure rather than in response to it
- —Distinct from calibration, which verifies measurement accuracy rather than mechanical condition
- —Major maintenance interventions are routed through change control for impact assessment
- —Overdue or missed tasks on critical equipment are treated as quality events
- —Feeds trend data reviewed during periodic review
21 CFR 211.67; EU GMP Chapter 3 (Premises and Equipment)
Frequently asked questions
What is Preventive Maintenance?
A scheduled, documented program of inspection, servicing, and component replacement performed on equipment, utilities, and facility systems before failure occurs, intended to sustain a system’s qualified or validated state, minimize unplanned downtime, and prevent maintenance-driven deviations from GMP-critical performance during routine operation.
Which regulations cover Preventive Maintenance?
21 CFR 211.67; EU GMP Chapter 3 (Premises and Equipment)