PharmTech March April 2026

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

March 19, 2026

Quality

50

2

FDA’s 2024-2025 guidances and policy signals, when read together, point to a digital-by-default oversight model built on structured data exchange, more routine remote engagement, and clearer expectations for lifecycle control of automated systems used in regulated decisions. This article translates those signals into practical steps for chemistry, manufacturing, and control, as well as quality management systems.

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

March 11, 2026

Peer Reviewed

50

2

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.