Water Quality Classification Specification
This specification defines the Quality Unit–approved water quality classifications and decision requirements for water used in GMP-relevant operations.
Authoritative Quality Control specification defining water quality classification and decision logic. This document does not define system design, treatment methods, sampling techniques, or monitoring execution.
1. Purpose
To establish Quality Unit–approved water quality classifications that ensure water used in GMP-relevant activities is suitable for its intended use and does not adversely impact product quality, safety, or compliance.
2. Scope
This specification applies to all water systems supplying water for GMP-relevant uses, including cleaning, processing, formulation, testing, and facility support where water quality may impact product or material quality.
Applicable Business Domains include:
- Facilities & Engineering (FAC)
- 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-UTIL-002
Water quality classifications and acceptance expectations defined in this specification shall not be modified outside approved QMS change control.
4. Water Quality Classifications
| Water Classification | Description | Typical GMP Uses |
|---|---|---|
| Potable Water | Water meeting applicable drinking water standards and suitable for non-product-contact GMP support activities. | Handwashing, facility cleaning, non-critical equipment cleaning |
| Purified Water | Water treated and controlled to meet defined chemical and microbiological quality expectations appropriate for GMP use. | Product-contact equipment cleaning, formulation support, testing |
| Other Defined Quality | Water meeting alternative or specialized quality requirements defined by approved product, process, or regulatory specifications. | Specialized processes or product-specific applications |
Water used in GMP-relevant operations shall be of a quality appropriate to its intended use. Where product- or process-specific requirements are more restrictive, the more restrictive requirements shall apply.
5. Decision Logic
- Water systems supplying water meeting approved classification requirements are considered conforming.
- Single or isolated water quality concerns require documented review by Quality Assurance.
- Confirmed, repeated, or significant water quality failures require escalation to Quality Control for impact assessment.
- Final determinations regarding water system suitability reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following conditions occur:
- Water quality does not meet its approved classification
- Recurring or unresolved water quality deviations are identified
- Potential impact to product quality or safety is identified
- Water system reliability or data integrity concerns are identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Water quality monitoring and test records
- Deviation, investigation, and corrective action documentation
- Quality Assurance reviews and escalation records
- Quality Unit determinations regarding water system suitability