| Field | Value |
|---|---|
| Document ID | QC-UTIL-002 |
| Title | Water Quality Classification Specification |
| Document Type | Authoritative QC Specification |
| Owner | Quality Unit (QU) |
| Approver | Quality Unit (QU) |
| Effective Date | YYYY-MM-DD |
| Version | v1.2 |
| Change Control Reference | CC-XXXX |
This specification establishes formal water quality classifications, measurable acceptance criteria, escalation thresholds, and authorization gates governing water used in GMP-relevant operations.
This control mitigates microbial, chemical, and conductivity-related contamination risks that may impact product identity, purity, strength, or composition.
Failure to define and enforce objective water quality controls creates regulatory exposure under 21 CFR Part 111 for sanitation, utilities, and production controls.
Applies To: Potable Water (PW), Process Water (PRW), and Purified Water (PUW) systems supplying GMP-designated areas.
Excludes: Municipal source governance beyond facility control. Confirmed impacts to water entering the GMP envelope remain within scope.
Compliant State: All acceptance criteria satisfied and documented.
Nonconforming State: One or more objective acceptance limits exceeded.
Invalid State: Required monitoring, testing, or documentation missing or incomplete.
Escalation Trigger: Objective condition requiring mandatory QMS process entry.
Stop-Execution Condition: Execution is prohibited when PUW exceedance occurs at a point-of-use serving open product exposure.
| Attribute | Compliant State | Nonconforming State | Invalid State | Escalation Trigger | Required QMS Process Entry | QU Authorization Required? |
|---|---|---|---|---|---|---|
| PUW Total Microbial Count | ≤ 100 CFU/mL | > 100 CFU/mL | Test record missing | Exceedance at point-of-use during open product exposure | Deviation + Quality Defect | Yes |
| PUW TOC | ≤ 500 ppb | > 500 ppb | Test record missing | Exceedance during active batch production | Deviation + Quality Defect | Yes |
| PUW Conductivity | ≤ 1.3 µS/cm at 77°F | > 1.3 µS/cm | Monitoring record missing | Exceedance persisting >1 hour during production | Deviation + Quality Defect | Yes |
| Trigger Condition | Execution May Continue? | Required Action | QMS Process Entry | Workflow (W)? | QU Authorization (A)? | Required Record |
|---|---|---|---|---|---|---|
| Compliant State | Yes | Continue operation | None | No | No | Water Monitoring Log |
| Nonconforming State | Conditional | Enter deviation | Deviation | Yes | No | Deviation Record |
| Escalation Trigger | No | Stop affected use | Deviation + Quality Defect | Yes | Yes | Defect Record + QU Authorization |
| Invalid State | No | Invalidate record | Deviation | Yes | No | Deviation Record |
When objective limits are exceeded, Deviation entry is mandatory.
When PUW contamination risk conditions occur, Quality Defect entry is mandatory.
When systemic recurrence thresholds are met, CAPA entry is mandatory.
When system redesign or architecture change occurs, Change Control entry is mandatory.
Compliant: All criteria satisfied.
Nonconforming: Any objective limit exceeded.
Invalid: Required documentation missing.
Escalation Trigger: PUW contamination risk condition or recurrence threshold met.
Stop-Execution Condition: PUW exceedance at point-of-use during open product exposure.
Change Control entry is required for modifications to classification, treatment, monitoring parameters, distribution architecture, or limits.
Independent Quality Unit approval is required prior to implementation.
No implementation is permitted without QU authorization.