Auditing vs. Monitoring [GxP / QC / QA]

posted by Ohlbe – France, 2015-01-05 13:20 (4177 d 06:48 ago) – Posting: # 14217
Views: 4,726

Dear M. Vasu,

❝ Monitoring and Auditing teams can report to same person or not.


Let's say that the head of monitoring and the head of QA can report to the same person within senior management. But monitoring and auditing teams should report to different heads. Have a look at ICH GCP § 5.19.1:
The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions...
—
Regards
Ohlbe

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