Establishing Ongoing Monitoring, Surveillance and Evaluation Programs

نویسنده

  • JEANNE MOLDENHAUER
چکیده

The environmental monitoring data that is generated should be collected in a manner that is in conformance with current Good Manufacturing Practices (cGMPs). The personnel supervising the environmental monitoring program should be competent in the appropriate scientific discipline and have the training (including within the industry) and the authority required to make and implement change. Equipment that is used should be calibrated, systems should be appropriately validated and/or qualified, media should be properly prepared, and all operational procedures should be written and followed.

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تاریخ انتشار 2006