New USP <1058> Analytical Instrument Qualification Regulations: What the 2017 Requirements Mean and How to Comply

The US Pharmacopeia (USP) General Chapter <1058> on Analytical Instrument Qualification (AIQ) has remained unchanged since its introduction in August 2008. Then in August and December 2017, USP implemented two separate updates to <1058>. These updates have global significance because the USP is the only major pharmacopeia with a chapter dedicated to AIQ. The 2017 updates demonstrate the evolution of USP thinking on AIQ; laboratories must review the changes very carefully or risk non-compliance. This manuscript examines the significance of the changes to <1058>, the role of AIQ in data integrity, and provides a structured approach for compliance with the new USP <1058> requirements.

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