Revalidation of DM water generation System

Water System
1

Dear Sir,

I have a query regarding the revalidation of DM water Generation system.

we have installed the system in 2012 and till now it is working fine and at the time of installation, performance qualification was conducted and got the desire results.
Apart from this, we don’t have the specific SOP for the revalidation of DM water plant.

Pls confirm what is the revalidation criteria if no change in the system and system is working as per requirement.

Pls also confirm if we will conduct the revalidation qualification, how many days / period required to conduct the analysis.

Regards,
Ravi Yadav

2 Likes
2

Usually, water systems are not requalified. Instead, there should be a review program that covers the aspects highlighted in WHO TRS 1033 Annex 3. This periodic review includes the review of routine monitoring trends. If any observation highlighted in the report justifies the need of revalidation, then we can move go for it. The strategy and frequency of sampling should be risk based in that case.