MAINT – Maintenance Business Process
The Maintenance (MAINT) business process governs the inspection, servicing, calibration, repair, and modification of equipment, utilities, and facilities to ensure continued suitability for GMP operations.
Maintenance Operating Model
The Maintenance Operating Model below illustrates how preventive and corrective maintenance activities are planned, executed, verified, and documented to support reliable and compliant manufacturing operations.
Approved maintenance plans and schedules
Equipment performance and condition data
Maintenance requests and work orders
Preventive maintenance scheduling and work authorization
Inspection, servicing, repair, and adjustment activities
Calibration, functional checks, and restoration of equipment status
Recording of work performed, parts used, and observations
Serviced and verified equipment
Updated maintenance and calibration records
Equipment released for GMP use
Maintenance activities may occur during planned downtime or as corrective actions. Equipment affected by maintenance is not returned to GMP service until verification requirements are met.
Process Interfaces & Boundaries
- Upstream: Production (PROD), Packaging (PKG), and Sanitation (SAN) – identification of maintenance needs
- Downstream: Production (PROD) and Packaging (PKG) – use of maintained equipment
- Governance: QMS defines maintenance, calibration, and change controls; Maintenance executes authorized work
Quality Control Requirements Supported by Maintenance
Maintenance is classified as a QC-Enabling Domain. Maintenance activities support defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) under the authority of Quality Control Operations (QCO).
- QC-UTIL-001 – Compressed Air Quality: Maintenance maintains and monitors compressed air systems to ensure quality classifications remain within defined limits.
- QC-UTIL-002 – Water Quality Classification: Maintenance supports water system control, monitoring, and maintenance to preserve required quality classifications.
- QC-UTIL-004 – Backflow & Cross-Connection Prevention: Maintenance ensures utilities and facility systems prevent contamination risks associated with cross-connections or backflow conditions.
- QC-CHG-003 – Validation & Requalification Governance: Maintenance activities that impact validated systems are executed in accordance with defined validation and requalification controls.
Maintenance does not independently establish acceptance criteria or make disposition decisions. All Quality Control determinations remain under defined QC authority.
Maintenance-related deviations, calibration failures, or unplanned equipment impacts are documented and escalated through the Quality Event and Change Management processes in accordance with the enterprise Quality System.