Facility Cleanliness Acceptance Specification
This specification defines the Quality Unit–approved cleanliness acceptance criteria and decision requirements for GMP-designated facility areas.
Authoritative Quality Control specification defining cleanliness acceptance criteria and decision logic. This document does not define cleaning methods, frequencies, agents, or execution procedures.
1. Purpose
To establish Quality Unit–approved cleanliness acceptance criteria for GMP-designated facility areas, ensuring that facility conditions do not present a risk to product quality, material integrity, or regulatory compliance.
2. Scope
This specification applies to all GMP-Controlled and GMP-Support Areas as defined in the Facility Classification & Zoning Specification.
Applicable Business Domains include:
- Facilities & Engineering (FAC)
- Warehouse Operations (WH)
- Production (PROD)
- Packaging (PKG)
- Quality Assurance (QA)
- Quality Control (QC)
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-FAC-002
Cleanliness acceptance criteria defined in this specification shall not be modified outside approved QMS change control.
4. Cleanliness Acceptance Criteria
| Area Classification | Acceptance Criteria | Notes |
|---|---|---|
| GMP-Controlled Area | Surfaces shall be clean, orderly, and free from visible residue, debris, dust accumulation, spills, or standing water. | Includes floors, walls, ceilings, equipment exteriors, and work surfaces. |
| GMP-Support Area | Areas shall be maintained in a clean and orderly condition with no visible contamination that could impact adjacent GMP-Controlled Areas. | Cleanliness expectations support, but do not replace, GMP-Controlled Area requirements. |
Cleanliness acceptance is based on documented visual assessment and, where applicable, approved inspection criteria. Absence of visible contamination is the minimum acceptance requirement.
5. Decision Logic
- Facility areas meeting cleanliness acceptance criteria are considered conforming.
- Minor, isolated cleanliness deficiencies require correction and documented review by Quality Assurance.
- Significant, recurring, or systemic cleanliness deficiencies require escalation to Quality Control.
- Final determinations regarding area suitability for GMP use reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following conditions occur:
- Visible contamination that may impact product or material quality
- Recurring cleanliness deficiencies in GMP areas
- Evidence of pest activity, water intrusion, or structural deterioration
- Conditions indicating failure of established cleaning controls
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Facility cleanliness inspection records
- Deviation or nonconformance reports related to cleanliness
- Corrective and preventive action documentation
- Quality assessments and disposition decisions