PharmTech March April 2026

This issue of PharmTech brings together perspectives from scientists, engineers, regulatory strategists, and industry veterans to chart where the field is headed.

Quality control for pharmaceuticals is evolving with the assistance of digital tools, sustainability practices, and a push to move manufacturing onshore.

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.

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

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.

The industry is shifting toward increasingly complex, precision-driven modalities for the treatment of cancer.

Ken Boda, Agilent, discusses small-volume dissolution for low-dose drugs and implants, emphasizing biorelevance, USP apparatuses, and technical risks.

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.