在将设备用于生产前，是否需要等擦拭样品和淋洗样品被批准？

Question 17: Do we have to wait for swaband rinse samples to be approved prior using the equipment for production?

Advice: During cleaning validation studies it is recommended to wait forcompletion of all planned tests prior to release equipment for further use (tobe able to perform an investigation if tests fail). In routine operations(after validation has been completed) the release of equipment pending testingresults (verification, monitoring status of the tests) could be done. Responsibilitiesand circumstances for using equipment pending release should be defined withinthe company.

问题17：在将设备用于生产前，是否需要等擦拭样品和淋洗样品被批准？

建议：在清洁验证研究期间，建议等所有计划的测试完成后在放行设备，用于后续使用（这样如果检测失败可以进行调查）。在日常运行中（验证完成后），可以在检测结果（核查、测试监控状态）未出来前将设备放行用于后续使用。公司应界定使用未放行设备的责任人和条件。