SAN – Sanitation Business Process
The Sanitation (SAN) business process governs the cleaning, sanitation, and hygiene controls applied to facilities, equipment, utensils, and controlled environments to prevent contamination and support GMP manufacturing operations.
Sanitation Operating Model
The Sanitation Operating Model below illustrates how cleaning and sanitation activities are planned, executed, verified, and documented to maintain hygienic conditions suitable for GMP operations.
Approved sanitation procedures
Equipment and area cleaning schedules
Authorized cleaning agents and tools
Area clearance, equipment disassembly as required, and safety controls
Application of approved cleaning and sanitation methods
Visual inspection, checks, and verification activities
Recording of cleaning activities, outcomes, and observations
Cleaned and sanitized equipment or areas
Verified hygienic conditions
Documented sanitation records
Sanitation activities are performed independently of batch execution and may occur before, during, or after manufacturing operations as defined by approved sanitation schedules and procedures.
Process Interfaces & Boundaries
- Upstream: Production (PROD), Packaging (PKG), and Maintenance – identification of sanitation needs
- Downstream: Production (PROD) and Packaging (PKG) – use of cleaned equipment and areas
- Governance: QMS defines sanitation standards and verification expectations; Sanitation executes approved controls
Quality Control Requirements Supported by Sanitation
Sanitation is classified as a QC-Enabling Domain. Sanitation activities support defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) under the authority of Quality Control Operations (QCO).
- QC-FAC-002 – Facility Cleanliness: Sanitation executes cleaning programs that maintain required levels of facility cleanliness for GMP operations.
- QC-FAC-003 – Facility Drain Design & Maintenance: Sanitation maintains and monitors drainage systems to prevent contamination risks associated with improper flow or residue accumulation.
- QC-UTIL-003 – Wastewater & Drainage Systems: Sanitation supports controls governing wastewater handling and drainage integrity within GMP areas.
Sanitation does not independently establish acceptance criteria or make disposition decisions. All Quality Control determinations remain under defined QC authority.
Sanitation failures, missed cleanings, or verification discrepancies are documented and escalated through the Quality Event process in accordance with the enterprise Quality System.