|
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? |
|
|
PEOPLE ALSO READ: SOP for Out of Acceptance Limit in Purified Water System
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 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? |
|
|
PEOPLE ALSO READ: Installation Qualification of Purified Water System
0 Comments