PharmTech September October 2026

The articles in the September/October 2026 issue of PharmTech show that control must be designed in, verified, and documented at every step.

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.

This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.

Effective modeling and simulation can reduce physical experimental requirements, ASD development risks, and time to market.

Postmarketing governance must be evidenced across the full life cycle—design, validation, and live monitoring—not documented once and assumed to hold.

PharmTech spoke with Dr. Hui-Yin (Harry) Li, president and CEO of Wilmington PharmaTech, about steps that should be taken to build a productive relationship between sponsor and contract organizations.

The future of synthetic biology will depend not only on the ability to design biological systems, but on the capacity to manufacture DNA reliably at scale within regulated frameworks.