Dear All,
Can we start Phase-I water validation prior to area qualification of main plant.
Regards
Prashant Mhetre
Answer a question with a question…How can you start the PQ if your “SYSTEM” has not been completely qualified? The PQ is slightly more broad based than just the water testing. A PQ tests to ensure that an array of smaller systems and functions work together in harmony to give you the predetermined output. The correct way would be to wait until the area is qualified but under certian circumstances, you could raise a deviation to explain the reasons why, attach the risk assessment that proves why the PQ should commence and try having it approved.
water validation or water system PQ performed after DQ, IQ and PQ are done
Importance of water validation as follow:
Validation of water treatment systems is mandatory to obtain water with all the desired quality characteristics
Pharmaceutical water production, storage and conveyance system should be validated because end-product testing alone is not a sufficient evidence to confirm with a high degree of assurance that the system operates as it is purported. In order to cater for the ever escalating quality needs of the pharmaceutical industry, water treatment systems, which are highly dynamic in nature, must be validated, closely monitored and controlled.