The proposed revision to USP <1058> introduces a significant change in the approach to analytical instrument and system qualification (AISQ). Instead of considering qualification as a series of isolated events, the updated chapter adopts a risk-based life-cycle approach that encompasses the entire life cycle of an analytical instrument—from specification and selection through installation and performance verification […]
Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry. The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’ This was the most significant change in this revision. So the question is, can you always average? If […]
In today’s blog, we want to create awareness that, after sixteen years, in May of 2022, the FDA has finally announced revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. (here). Specifically, this revision updates terminology for consistency with current FDA guidance, e.g., the quality control unit “QCU” is changed to the […]
