A.R Jafari Arimi - Critical System Production Department, Research and Production Complex Pasteur Institute, Tehran-Iran. P.O.Box. ۳۱۵۹۹.

Validation is defined as assuring that the particular system will consistently produce water of predictable quality when operated in the prescribed manner. The regular performance of qualification and validation is of prime importance to ensure a good and continuous water quality for the manufacture of biopharmaceutical products. Validation and qualification concepts was applied to new high purity (HP) water system mainly purified water (PW)and water for injection(WFI) in recombinants biopharmaceutical plant . All qualification and validation activities were done in order to produce HP water in constant manner with the desire quality .extensive monitoring and testing also performed to demonstrate the system capability to produce water through the acceptance criteria. The result showed that system is capable to produce consistently HP water for production plant according to quality attributes and regulatory expectation.

High Purity Water, Qualification, Validation, WFI, PW, Biopharmaceutical