QA Review of QA documents

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

Hi,

Can a QA Associate sign an SOP for approval as both the author and the QA review? Our facility is very small and there is only one staff member in the QA department at the moment. The document will be reviewed and signed by managers and the facility director. But I’m just wondering if it would be necessary for someone else to act as a “QA Reviewer”.

Thanks!

Bahati

2

Yes and no! Yes = As long as they are authorized by the QA manager to do so. No = But they cannot at the same time be the author, or reviewer. Thus, get someone else to sign approval like the QC Manager, VP of Quality, Quality Site Head…