The pivotal batch size is 10 % or greater of the largest proposed commercial lot?
关键批的大小是否是正式批次的10%的量，或者更大？
The pivotal batch manufacturing equipment is standard production equipment operated by production staff with routine QA personnel?
关键批的生产设备是常规的QA人员操作的标准生产设备吗？
The pivotal batch manufacturing equipment is standard production equipment operated by production staff with routine QA personnel?
关键批的生产设备是常规的QA人员操作的标准生产设备吗？
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