GMP Audit checklist for Water Supply System

Water Supply system

• Is there a validated system for water treatment drawn from own or other sources?
• Is the water system maintained according to standards given by local municipal or BIS norms?
• Are the sources of raw water, treatment processes, sampling plans specified?
• Are the distribution points and storage for raw and purified water system specified?
• How is the bioburden of purified water system reduced or controlled?
• Are the water tanks cleaned periodically?
• Are records maintained on cleaning activities?
• Is the water distribution system sanitized to control contamination due to microbes?
• Are the cleaning procedures and critical support systems validated?
• Is the qualification of water system done in accordance with the protocol?
• Does the IQ protocol include the review of facility and specifications of equipment like its design, welding roughness on pipelines, dead points or sections in the pipelines?
• Does the protocol include SOP for operations, maintaining, cleaning and calibration of gadgets?
• Does the report for IQ protocol include Summary and description of the assay performed with data tables, results conclusions, reference of the protocol and revision and approval signatures?
• Does the OQ protocol include system production capacity (L/min), water rate, flow type, valve operation with alarm and control operations?
• Is a report maintained on OQ protocol with summary, description, data tables, conclusion, results, and reference of the protocol, revision and approval signatures?
• Are the three stages of PQ followed in phases 1, 2, 3?
• Are the operation parameters, sanitation and cleaning procedures followed in Phase 1?
• Are the SOPs prepared and maintained for phase 1 with sampling records for 2-4 weeks?
• Are the sampling records maintained for every pretreatment point in phase 2 after phase 1?
• Are the sampling records maintained for every pretreatment point in phase 3?
• Are there any personal training records?
• Is the design for water for injection system adequate for supplying enough water of pharmacopoeial quality?
• Is the holding tank for WFI system fitted with sterilizing grade vent filter which is integrity tested?
• Is the WFI held at more than or equal to 80^oc when stored on continuous circulation?
• Are the dead legs for WFI system within an acceptable length?
• Is the WFI used as lubricant on recirculation pumps?
• Are limits for microbes and physical and chemical characteristics established for water systems?
• Are measures taken when the limits exceed for water system?

Water supply system, wfi, purified water,gmp audit checklist

• mcrhrdi.gov.in
• cdsco.nic.in