auditor ★ India, 2012-02-03 09:28 (4866 d 00:45 ago) Posting: # 8048 Views: 1,553 |
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Dear All, In one of the validation it is observed that the ULOQ is decreased from 3000 pg/ml to 500 pg/ml. To justify this only one P&A is injected. I feel to justify this recovery and DI need to be perform again as QC level is also change accordingly. Kindly give you suggestion on this. Regards, Auditor |