Pdf — Usp 38

One of the most impactful inclusions in the USP 38 revision cycle was the refinement of guidance regarding Analytical Instrument Qualification (AIQ). This chapter provides a framework for ensuring that instruments used in testing are suitable for their intended purpose. It outlines the "4 Qs" model: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This remains a cornerstone for GMP compliance.