GxP受控环境的测量、监测和验证.pptVIP

Most basic: manually record the data from the monitoring devices at regular intervals, sign and date the records, and file them away. Problems:  Time-consuming Prone to reader error Requires rigid adherence to a schedule — very tough. Likely to fall short. Your company will need a standard operating procedure that describes the monitoring frequency, log book for entering the data, date of monitoring, and initials of the person recoding the data. ? While this may seem to repeat some of the information on the earlier slides, here were talking about monitoring as opposed to validation. Visual checks and handwritten records are a particular problem in monitoring, because monitoring is an ongoing activity. Doing it by hand can be laborious and prone to error. * Once you’ve identified areas of risk in your environment, it’s time for Step 5—writing a protocol for your first mapping test. ? What’s the difference between the validation protocol and the validation plan we discussed in Step 1? ? Validation plan is the big picture—the objectives, the scope, the approach, the responsibilities. ? Protocol is more specific. It spells out the how and why of actually conducting the mapping. ? (Your initial protocol will describe how to conduct your initial mapping test. As we’ll see, you’ll later revise your protocol for future mapping tests.) * Finally, what are the reporting requirements? What data will the report contain? How will it be displayed and analyzed? Who sees it? How will it be stored? ? Your protocol is your roadmap, with all the directions. Once you develop a protocol, follow it consistently. Change it as you need to. Be sure to document the changes and provide the reasons for the changes. * * * * After you’ve identified likely risk areas and determined sensor distribution, it’s time for Step 6—to set up mapping equipment and conduct your initial mapping test of the storage space. ? Why are you doing this first test? You are trying to pinpoint risky, var