Audit checklist for Purified Water System
Purified water is water that has been mechanically filtered or processed to remove impurities like bacteria, viruses, chemical pollutants, and minerals like lead and copper, Purified Water is intended for use as an ingredient of official preparations and in tests and assays unless otherwise specified. Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection. The tests for Total organic carbon and Conductivity apply to Purified Water produced on-site for use as an ingredient of official preparations and in tests and assays
CRITICAL AND MAJOR DEFICIENCIES
Audit checklist
- Is there a validated system for Purified water treatment drawn from our own or other sources?
- 2 Are the sources of raw water, treatment processes, and sampling plans specified?
- Are the distribution points and storage for raw and purified water systems specified?
- How is the bioburden of the 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 the water system done in accordance with the protocol?
- Does the IQ protocol include the review of the 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 a Summary and description of the assay performed with data tables, results in conclusions, reference of the protocol, and revision and approval signatures?
- Does the OQ protocol include system production capacity (L/min), water rate, flow type, and valve operation with alarm, and control operations?
- Is a report maintained on OQ protocol with a summary, description, data tables, conclusion, results, and
reference of the protocol, revision, and approval signatures? - Are the three stages of PQ followed in phases I, II, and III?
- Are the operation parameters, sanitation, and cleaning procedures followed in Phase I?
- Are the SOPs prepared and maintained for phase I with sampling records for 2-4 weeks?
- Are the sampling records maintained for the pre-treatment point in phase II after phase I?
- Are the sampling records maintained for the pre-treatment point in phase III?
- Are there any personal training records?
- Is the design for the Purified water system adequate for supplying enough water of pharmacopoeial quality?
- Is the holding tank for the Purified water system fitted with sterilizing grade vent filter which is integrity tested?
- Is the Purified water held at more than or equal to 80oc when stored on continuous circulation?
- Are the dead legs for the Purified water 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 the water system?
