USPEP Purified Water and Water for Injection Systems uspep纯化水和注射用水系统.pptVIP

Validation Criteria IQ Information Limits on material? The more information available, the better. If a accessory breaks, it must be replaced. The model number, serial number, and/or manufacturer may change or no longer exists. “Cut sheets” of accessories provide an excellent vehicle for identifying a “like-for-like” replacement which significantly reduces the “Change Control” effort. Validation Criteria IQ Information All support information should reference the original manufacturer’s part number. Project specifications should clearly state that the name of the manufacturer as well as the part number be provided. The vast majority of this information is “coded” to the water purification equipment manufacturer’s model number, useless for replacement on a “like-for-like” basis. Validation Criteria OQ Information Prepared and executed in an integrated basis. Individual Unit Operation will impact the operation of other components. Execution must provide exact operating condition. As an example, if media is not installed in a pretreatment component during execution of a FAT, execution (partial) may be required after installation and start-up. Validation Criteria OQ Information – Considerations Fixed alarm and operating set points versus adjustable set points Processor access levels Alarm set points and time delays Control set points and time delays View screen navigation “ALERM” banner display “OPERATOR OVERRIDE” banner display Validation Criteria PQ Criteria Post start-up and commissioning 30 day sample period Sampling plan to duplicate water use “Working days” Attempt to duplicate water demand Attempt to duplicate actual conditions at individual points-of-use Validation Criteria PQ Criteria Every point-of-use every day if practical TOC “grab” samples from each points-of-use Conductivity “grab” samples from points-of-use Suggest transition for about 30-60 days after successful execution Continues for one year period Monitoring never stops Validation Crite