Quality Systems

This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026.

Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

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.

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.

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

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.

New US pharmaceutical tariffs reach up to 100%, with exemptions for companies that strike pricing deals or commit to domestic manufacturing.

Indirect data suggest oral semaglutide outperforms orforglipron on weight loss and tolerability, with patients also favoring its treatment profile.

The agency has issued a draft qualification opinion on a new preclinical research methodology.

Contract development and manufacturing organizations can assist the sponsor company in ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines.

The FDA approved a high-dose nusinersen regimen for spinal muscular atrophy, offering pharma teams key insights into dose optimization and lifecycle management.

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, relapsed extensive-stage small cell lung cancer, activated phosphoinositide 3-kinase delta syndrome, and oedema of cardiac, renal, hepatic origin, and hypertension in children.

Excipients contribute to more sustainable practices throughout the life cycle of a drug.