PW distribution system has been renovated through 01 new use point incorporation & relocation of two other existing use points. What will be the mode of requalification of the system ? Is it required to perform P-1, P-2 & P-3 phase up to 1 year ? Pls. suggest.
You have to demonstrate consistent operation of whole purified water system within the established ranges as follows after plan and execution of purified water system followed for the addition of user point and relocation of the user points to the existing loop system of purified water.
The above said activity shall be addressed through the change control and addendum validation report is for Initial Purified Water System Validation.
sampling schedule shall be carried out 14 days, by covering all the points for Physical, chemical, Microbial and TOC analysis.
In schedule ensure additional point (new point), relocation points and return loop points shall be covered daily for microbial and TOC analysis.
Note: During these 14 days water should be used for manufacturing.
After 14 days of validation compilation report shall be prepared and conclude. If all results were withing the specification limits, without any abnormalities then purified water can be used for manufacturing process and other usages and also recommended that it to continue the purified water system maintenance, treatment, sampling, testing and usage based up on the yearly / annual schedule and then evaluate the test results and other parameters once in a year.