|
Sr. No. |
Compliance to be
checked |
Complies as per
established Systems? Yes/No |
Reference Document |
|
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? |
|
|
|
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 pharmacopeial 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 80℃ 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? |
|
|
ALSO READ: Audit Checklist for Production Department
