Audit Checklist for Purified Water System

Complies as per
Reference
Sr. No. Compliance to be checked established Systems?
Document
Yes/No
1. Is there a validated system for water
treatment drawn from own or other
sources?
2. Are the sources of raw water,
treatment processes, sampling plans
specified?
3. Are the distribution points and storage
for raw and purified water system
specified?
4. How is the bioburden of purified water
system reduced or controlled?
5. Are the water tanks cleaned
periodically?
6. Are records maintained on cleaning
activities?
7. Is the water distribution system
sanitized to control contamination due
to microbes?
8. Are the cleaning procedures and
critical support systems validated?
9. Is the qualification of water system
done in accordance with the protocol?
10. 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?
11. Does the protocol include SOP for
operations, maintaining, cleaning and
calibration of gadgets?
12. 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?
13. Does the OQ protocol include system
production capacity (L/min), water
rate, flow type, valve operation with
alarm and control operations?
14. Is a report maintained on OQ protocol
with summary, description, data
tables, conclusion, results, and
reference of the protocol, revision and
approval signatures?
15. Are the three stages of PQ followed in
phases 1, 2, 3?

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16. Are the operation parameters,
sanitation and cleaning procedures
followed in Phase 1?
17. Are the SOPs prepared and maintained
for phase 1 with sampling records for
2-4 weeks?
18. Are the sampling records maintained
for pre-treatment point in phase 2 after
phase 1?
19. Are the sampling records maintained
for pre-treatment point in phase 3?
20. Are there any personal training
records?
21. Is the design for PW system adequate
for supplying enough water of
pharmacopoeial quality?
22. Is the holding tank for PW system
fitted with sterilizing grade vent filter
which is integrity tested?
23. Is the PW held at more than or equal
to 80oc when stored on continuous
circulation?
24. Are the dead legs for PW system
within an acceptable length?
25. Are limits for microbes and physical
and chemical characteristics
established for water systems?
26. Are measures taken when the limits
exceed for water system?