| SOP | WIN | AA Doc ID | Type | Frequency | Description (Purpose, Scope & Audit Focus) |
|---|---|---|---|---|---|
| SOP-MAINT-PM | |||||
| WIN-MAINT-PM-CHK | AA-MAINT-PM-CHK | CHK | Scheduled |
Purpose: Verify scheduled preventive maintenance activities are completed and documented. Scope: GMP-relevant equipment and systems subject to preventive maintenance. Auditor Focus: Adherence to schedules, completion records, and resolution of overdue tasks. |
|
| SOP-MAINT-CAL | |||||
| WIN-MAINT-CAL-REC | AA-MAINT-CAL-REC | REC | Per Calibration Event |
Purpose: Provide objective evidence of instrument calibration results. Scope: Instruments and devices requiring calibration for GMP operations. Auditor Focus: Calibration status, traceability, and out-of-tolerance handling. |
|
| SOP-MAINT-CAL-PROGRAM | |||||
| WIN-MAINT-CAL-PROGRAM-LOG | AA-MAINT-CAL-PROGRAM-LOG | LOG | Periodic |
Purpose: Document oversight and review of the calibration program. Scope: Program-level evaluation of calibration effectiveness and compliance. Auditor Focus: Periodic review, trend analysis, and program governance. |
|
| SOP-MAINT-FACILITY | |||||
| WIN-MAINT-FACILITY-CHK | AA-MAINT-FACILITY-CHK | CHK | Periodic |
Purpose: Verify facility structures and infrastructure remain suitable for GMP operations. Scope: Building integrity, surfaces, utilities interfaces, and general condition. Auditor Focus: Facility suitability, identified deficiencies, and corrective actions. |
|
| SOP-MAINT-UTILITIES | |||||
| WIN-MAINT-UTILITIES-LOG | AA-MAINT-UTILITIES-LOG | LOG | Ongoing |
Purpose: Maintain chronological monitoring of facility utilities. Scope: Water, plumbing, sewage, and other critical utilities. Auditor Focus: Monitoring consistency, excursions, and response actions. |
|
| SOP-MAINT-FACHYG | |||||
| WIN-MAINT-FACHYG-CHK | AA-MAINT-FACHYG-CHK | CHK | Periodic |
Purpose: Verify hygienic facility conditions are maintained. Scope: GMP areas requiring hygienic controls and cleanliness. Auditor Focus: Sanitation effectiveness and prevention of contamination risks. |
|