Facility Classification & Zoning Specification
This specification defines the Quality Unit–approved classification and zoning requirements for GMP-designated facility areas.
Authoritative Quality Control specification defining facility classification, zoning requirements, and decision authority. This document does not define cleaning procedures, access controls, or operational workflows.
1. Purpose
To establish Quality Unit–approved facility classification and zoning requirements that ensure appropriate segregation, control, and protection of materials and products across GMP-relevant facility areas.
2. Scope
This specification applies to all facility areas used for GMP-relevant activities, including receipt, storage, production, packaging, labeling, testing, and retained sample storage.
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-001
Facility classifications and zoning requirements defined in this specification shall not be modified outside approved QMS change control.
4. Facility Classification
| Classification | Description | Examples |
|---|---|---|
| GMP-Controlled Area | Areas where GMP materials, products, or components are exposed or handled and where environmental and cleanliness controls are required. | Production rooms, packaging areas, GMP warehouses, retained sample storage |
| GMP-Support Area | Areas that support GMP operations but where materials or products are not directly exposed. | Equipment wash areas, gowning rooms, material staging corridors |
| Non-GMP Area | Areas with no direct or indirect impact on GMP materials or products. | Offices, break rooms, administrative spaces |
5. Zoning Requirements
Facility zoning shall be established to prevent contamination, mix-ups, and unauthorized access between areas of differing GMP classification.
- GMP-Controlled Areas shall be physically or procedurally segregated from Non-GMP Areas
- Material and personnel flow shall be designed to minimize cross-contamination risk
- Transitions between zones shall be clearly defined and controlled
- Zoning shall support product protection, not operational convenience
6. Decision Logic
- Areas classified and zoned in accordance with this specification are considered conforming.
- Deviations from approved classification or zoning require Quality Assurance review.
- Changes impacting GMP-Controlled Areas require escalation to Quality Control and QMS change control approval.
- Final classification and zoning decisions reside with the Quality Unit.
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Facility layout diagrams and zoning maps
- Area classification documentation
- Change control records impacting facility layout or use
- Quality assessments and classification approvals