| SOP | WIN | AA Doc ID | Type | Frequency | Description (Purpose, Scope & Audit Focus) |
|---|---|---|---|---|---|
| SOP-SAN-CLEAN | |||||
| WIN-SAN-CLEAN-EXEC | AA-CHK-SOP-SAN-CLEAN-PREOP-EVT | CHK | Per Use / Pre-Op |
Purpose: Verify sanitation is complete prior to GMP operations. Scope: Equipment and areas requiring sanitation before use. Auditor Focus: Pre-op sanitation verification and sign-off. |
|
| WIN-SAN-CLEAN-EXEC | AA-LOG-SOP-SAN-CLEAN-ROUTINE-DLY | LOG | Daily |
Purpose: Record routine sanitation activities. Scope: Daily sanitation tasks. Auditor Focus: Completeness and consistency of sanitation logs. |
|
| WIN-SAN-CLEAN-EXEC | AA-REC-SOP-SAN-CLEAN-RELEASE-BCH | REC | Per Cleaning |
Purpose: QA release of sanitized areas or equipment. Scope: GMP areas following sanitation. Auditor Focus: QA approval prior to use. |
|
| SOP-SAN-MASTER | |||||
| WIN-SAN-MASTER-SCHED | AA-TMP-SOP-SAN-MASTER-SCHEDULE-APR | TMP | Ongoing |
Purpose: Define sanitation tasks and frequencies. Scope: Facility-wide sanitation program. Auditor Focus: Approved schedule and coverage. |
|
| WIN-SAN-MASTER-REVIEW | AA-REC-SOP-SAN-MASTER-REVIEW-APR | REC | Annual |
Purpose: Periodic sanitation program review. Scope: Effectiveness and adequacy of sanitation controls. Auditor Focus: Management oversight and approval. |
|
| SOP-SAN-EMP | |||||
| WIN-SAN-EMP-SAMPLE | AA-FRM-SOP-SAN-EMP-SAMPLING-EVT | FRM | Per Sample |
Purpose: Document EMP sample collection. Scope: Environmental monitoring activities. Auditor Focus: Traceable sampling records. |
|
| WIN-SAN-EMP-REVIEW | AA-REC-SOP-SAN-EMP-RESULTS-BCH | REC | Per Event |
Purpose: Record EMP results and disposition. Scope: Monitoring results and trending. Auditor Focus: Response to adverse trends. |
|
| WIN-SAN-EMP-HYGIENE | AA-CHK-SOP-SAN-EMP-HYGIENE-DLY | CHK | Daily |
Purpose: Verify employee hygiene compliance. Scope: GMP personnel hygiene practices. Auditor Focus: Hygiene enforcement. |
|
| WIN-SAN-EMP-TRAIN | AA-REC-SOP-SAN-EMP-TRAINING-REL | REC | Per Training |
Purpose: Document sanitation & hygiene training. Scope: All GMP employees. Auditor Focus: Training completion evidence. |
|
| SOP-SAN-PEST | |||||
| WIN-SAN-PEST-INSPECT | AA-CHK-SOP-SAN-PEST-INSPECTION-MTH | CHK | Monthly |
Purpose: Verify pest control conditions. Scope: Facility pest control program. Auditor Focus: Inspection findings and actions. |
|
| WIN-SAN-PEST-TREND | AA-LOG-SOP-SAN-PEST-ACTIVITY-MTH | LOG | Monthly |
Purpose: Track pest activity and corrective actions. Scope: Pest sightings and trends. Auditor Focus: Trending and escalation. |
|