We use purified water for every manufacturing and testing activities, how to give Analytical record number of purified water to the manufacturing process of the current day although the manufacturing activity has been started in the morning at 6am and testing of water started later on around 9am…? Is there any scope of giving previous day AR number or else…
At what time do you collect water for sampling purpose?
Sampling of water is done by QC Departments and its around 9 am morning and testing starts around half an hour further. There are around 3 sampling points in a day to be tested including return loop.
Collection of water for sampling should be done before start of manufacturing process.from your reply it seems water sampled on previous day is used in process.generation of ar no.is done at the time of testing of water sample only.
Yeah it seems we are using previous day water and giving AR number of the current day which is generated till noon and by that time manufacturing activity completed to half of process, which i believe is wrong. But side by side we have done a study that if previous day water if used has no impact on microbial and chemical activity of water.
Even we do trend analysis of water , till date no failures are reported, we have a trend for the same , my concern is that can we claim on behalf of that trend analysis and study both that either water if used of previous day or if we proceed for manufacturing activity without water testing by that time and AR number can be given accordingly later on in the noon can have no impact on product quality. We can go for scientific rationale based upon these ideas. Kindly suggest
Yes, you can justify as what you mentioned because your water system is already validated in Phase-I,II&III and you may also having online TDS/Conductivity/PH meter for continuous monitoring of water system…If any set parameter fail u can alerted by inbuilt alarm system…then u can take necessary action.