GMP Audit Check List- Water Supply System
1. System Design & Validation
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Water system (Purified Water, WFI, Potable Water) designed to meet pharmacopeial requirements (USP/EP/IP/JP).
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System qualification performed (DQ, IQ, OQ, PQ) with proper documentation.
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Risk assessment performed for potential contamination points.
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Materials of construction (SS 316L, sanitary design) appropriate and certified.
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System designed to maintain water in a state of continuous circulation.
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Dead legs avoided or within acceptable length (≤ 1.5 × pipe diameter).
2. Source & Pretreatment
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Potable water source meets WHO/local authority standards.
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Pretreatment (sand filter, carbon filter, softener, RO, UV, etc.) validated.
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Regular monitoring of microbial and chemical quality.
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Backwash, sanitization, and regeneration records maintained.
3. Storage & Distribution
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Storage tanks designed with sloped bottom, spray ball, vent filters, and sanitary design.
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Tanks and loops equipped with proper insulation, drains, and sample points.
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Continuous circulation maintained with proper velocity (> 1 m/sec).
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Distribution loops validated for hot water/ozone sanitization.
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No stagnant water in system (regular flushing practiced).
4. Monitoring & Testing
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Routine testing of water for chemical, microbial, and endotoxin (for WFI).
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Sampling points identified, labeled, and mapped.
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Online monitoring available for conductivity, TOC, temperature, and pressure.
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Alert and action limits established for microbial counts.
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Trend analysis of water quality data maintained.
5. Sanitization & Maintenance
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Periodic sanitization performed (heat, chemical, or ozone).
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Frequency of sanitization defined in SOP.
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Maintenance and calibration of sensors/instruments performed as per schedule.
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Preventive maintenance records maintained.
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Change control implemented for modifications in system design.
6. Documentation
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SOPs available for operation, cleaning, sanitization, and maintenance.
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Logbooks maintained for system operation, cleaning, and testing.
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Deviations, OOS/OOT related to water documented and investigated.
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Audit trails available for electronic monitoring systems.
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Validation and qualification reports readily retrievable.
7. Compliance & Safety
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Water system complies with regulatory requirements (USFDA, EMA, WHO, etc.).
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Labels on pipelines (Potable, PW, WFI, Hot Water) clearly visible.
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Proper segregation between potable and purified water lines.
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Access to control panels restricted to trained personnel.
✅ Key Audit Focus Points:
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Biofilm prevention measures.
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Compliance with pharmacopeial limits.
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Observation of sampling practices.
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Trending of microbial/endotoxin failures.
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