Q7A states in Section 8.4 that out-of-spec batches should not be blended with other batches for the purpose of meeting specifications.
Q7A 指南在第8.4 部分说,超标批次不能和其他批次混粉来达到符合规格标准的目的。
2
If the sample is still outofspec, record the data in LIMS as an offset.
如果结果仍然不符合规格,则把分析数据记录在LIMS系统中并标记为有偏差样品。
3
A program manager does go to a lot of meetings, but doesn't produce much other than that written spec, which is why as a twerp fresh outof school I was still able to do the job.