Audit Checklist for Purified Water System

Audit Checklist for Purified Water System Complies as per established Systems? Yes/No

Sr. No.

Compliance to be checked

1.

Is there a validated system for water treatment drawn from own or other sources? 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 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?

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Reference Document

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26.

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 pre-treatment point in phase 2 after  phase 1? Are the sampling records maintained for pre-treatment point in phase 3? Are there any personal training records? Is the design for PW system adequate for supplying enough water of  pharmacopoeial quality? Is the holding tank for PW system fitted with sterilizing grade vent filter which is integrity tested? Is the PW held at more than or equal to 80oc when stored on continuous circulation? Are the dead legs for PW system within an acceptable length? Are limits for microbes and physical and chemical characteristics established for water systems? Are measures taken when the limits exceed for water system?

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