Analytical Quality Control News

In Pharmacopeial Forum 51(4), the USP has published a major revision of General Chapter <1039> Chemometrics for public comment. The update reflects the rapid evolution of the field, particularly driven by developments in machine learning and AI.

In Pharmacopeial Forum 51(4), the USP proposes a new General Chapter <1221> Ongoing Procedure Performance Verification. As Stage 3 of the Analytical Procedure Life Cycle (<1220>), the chapter introduces a risk-based approach to ensure consistent method performance during routine use. The draft is open for public comment until 30 September 2025.

A recent FDA Warning Letter reveals severe GMP breaches at a U.S. drug manufacturer, including the absence of written procedures, reliance on undocumented processes, and a failure to perform basic analytical testing such as identity, strength, and microbiological checks prior to product release.

In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) criticizes major analytical GMP violations observed during an inspection at a Chinese drug manufacturing facility. These include a lack of release testing and unsupported expiry dates for products intended for the U.S. market.