Quality Systems

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

Drug shortages are rising. Learn what's breaking the pharmaceutical supply chain, and what industry leaders are doing to fix it.

Rohan Kumar, laboratory analyst at CS Analytical, discusses how sustainability in pharmaceutical packaging can be improved.

This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.

This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars.

New PRAC safety data link cenobamate to rare severe liver injury, prompting updated monitoring requirements and revised product labeling for prescribers.

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

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions.

This article details what co-processed excipients are and how they are made.

In this Drug Digest episode, Abzena’s vice president of Regulatory Strategy, Jeff Mocny, and Cellares’ director of Regulatory Affairs, Anna McMahon, examine how evolving regulatory and quality expectations are reshaping biopharmaceutical development and manufacturing.

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.