| Field | Value |
|---|---|
| Document ID | QC-FAC-002 |
| Title | Facility Cleanliness Acceptance Specification |
| Document Type | Authoritative QC Specification |
| Owner | Quality Unit (QU) |
| Approver | Quality Unit (QU) |
| Effective Date | MM/DD/YYYY |
| Version | v1.3 |
| Change Control Reference | QMS-XXXX |
This specification establishes objective facility cleanliness acceptance criteria for GMP-designated areas. It defines measurable environmental and structural conditions required to maintain a state suitable for the protection of components, in-process materials, packaging materials, labels, and finished product.
This specification mitigates risk of contamination, adulteration, cross-contact, pest intrusion, environmental degradation, and facility-related quality failure that could compromise product identity, purity, strength, or composition.
Failure to maintain controlled facility cleanliness conditions may result in product adulteration under 21 CFR Part 111 and regulatory enforcement exposure, including product seizure, recall, or injunction.
Applies To: All GMP-designated warehouse (WH), material readiness (MR), production (PROD), packaging (PKG), sampling, and retained sample storage areas.
Excludes: Administrative offices and non-GMP areas not used for storage, handling, or processing of GMP materials.
Compliant State: All acceptance criteria satisfied.
Nonconforming State: One or more acceptance criteria not met.
Invalid State: Record incomplete, missing required element, missing authorization, or control parameter undefined.
Escalation Trigger: Objective condition that requires mandatory entry into a defined QMS process.
Stop-Execution Condition: Execution is prohibited until resolution under QMS governance.
| Attribute | Compliant State | Nonconforming State | Invalid State | Escalation Trigger | Required QMS Process Entry | QU Authorization Required? |
|---|---|---|---|---|---|---|
| Surface Cleanliness | Zero visible residue on floors, walls, ceilings, and equipment surfaces. | Any visible residue observed. | Inspection record incomplete or unsigned. | When residue is observed, Deviation entry is mandatory. | Deviation | No |
| Pest Evidence | Zero evidence of pests, droppings, nesting, or insect activity. | Any pest evidence observed. | Pest inspection documentation incomplete or missing. | When pest evidence is observed, Deviation entry is mandatory. | Deviation + Quality Defect (if material exposure occurred) | Yes (if exposure occurred) |
| Waste Control | Waste containers closed and ≤90% capacity. | Overflowing or open waste container. | Inspection not documented. | When overflow or open waste is observed, Deviation entry is mandatory. | Deviation | No |
| Structural Integrity | No cracks, water intrusion, shedding, or structural breach. | Any breach or water intrusion observed. | Inspection not documented. | When structural breach observed, Deviation entry is mandatory. | Deviation + Change Control | Yes (for facility modification) |
| Trigger Condition | Execution May Continue? | Required Action | QMS Process Entry | Workflow (W)? | QU Authorization (A)? | Required Record |
|---|---|---|---|---|---|---|
| Compliant State | Yes | Continue execution. | None | No | No | Facility Inspection Log |
| Nonconforming State (No Exposure) | Yes | Escalate under QMS. | Deviation | Yes | No | Deviation Record |
| Stop-Execution Condition (Exposure Risk) | No | Execution is prohibited until QU authorization. | Deviation + Quality Defect | Yes | Yes | Deviation Record + QU Authorization Record |
| Repeated Nonconformance (≥3 within 30 days) | Yes | Systemic evaluation required. | CAPA | Yes | Yes | CAPA Record |
| Invalid State | No | Execution is prohibited until record corrected. | Deviation | Yes | No | Corrected Record + Deviation Record |
When objective limits are exceeded, Deviation entry is mandatory.
When material exposure or contamination risk exists, Quality Defect entry is mandatory.
When systemic recurrence threshold is reached, CAPA entry is mandatory.
When structural modification is required, Change Control entry is mandatory.
E — Execution: Perform and document inspections.
W — Workflow: Mandatory QMS entry when triggered.
A — Authorization: QU authorization required where specified.
Execution authority does not confer disposition authority.
Compliant: All criteria satisfied.
Nonconforming: Any objective limit failed.
Invalid: Record incomplete or missing.
Escalation Trigger: Objective condition requiring QMS entry.
Stop-Execution Condition: Execution is prohibited until resolved under QMS governance.
Change Control entry is required for any modification to limits, thresholds, escalation triggers, or authorization gates. Independent QU approval is required. Implementation shall not occur without QU authorization.