Quality Systems

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.

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.

This article explores key engineering strategies that support this transformation, including hybrid reactor design, clean-in-place optimization, automation architecture, and modular scalability.

This week, three core themes have emerged: the digital transformation of quality systems through AI and hybrid cloud architectures; the pursuit of supply chain resilience via onshoring and advanced mapping; and a regulatory push toward real-time data and flexible approval pathways.

FDA approves first therapy for Hunter syndrome's neurologic symptoms via surrogate endpoint, signaling evolving rare disease development standards.

New legislation will improve patient access to innovative medicines in Europe and the United Kingdom.

In this episode of Ask the Expert, Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being used to fight counterfeiting and how predictive modeling can be used to validate transport conditions.

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

The FDA approved higher-dose semaglutide (7.2 mg) in 54 days under its new priority voucher program, signaling faster reviews for drug developers.

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

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