Quality Systems

The European Commission has approved GSK’s adjuvanted recombinant respiratory syncytial virus vaccine, Arexvy, for use in adults aged 18 years and older.

The United States Pharmacopeia is developing digital standards for digital-first workflows and regulatory confidence.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how involving procurement early on in drug development can ensure a quality product.

Ensuring quality, sterility, and regulatory compliance are essential when choosing analytical methods.

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

To combat growth and pricing pressures, companies are auditing their supply chains and API material providers.

China clears GSK’s Nucala (mepolizumab) for COPD, highlighting growing acceptance in the country for biomarker-driven therapies.

This paper provides a technical assessment of compendial tests commonly found in the European Pharmacopoeia, the United States Pharmacopeia–National Formulary, and the Japanese Pharmacopoeia, detailing differences between the methods and acceptance criteria, and the potential impact of these differences on multi-compendial compliance.

In this overview, PharmTech takes a look back at significant news in the development and approval of cancer treatment in 2025.

David Basile, VP Technical Operations, Americas, Hovione, highlights some common mistakes made by pharmaceutical companies when maintaining manufacturing facilities and equipment.

Pharmaceutical Technology®’s quality experts, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel discuss how pharmaceutical manufacturing training has evolved over the years and how the influx of new facilities is demanding a skilled workforce.

André Cerbe, CEO of Schlafender Hase, spoke with Pharmaceutical Technology® about the disruptions the pharma industry faced in 2025 and how digital workflows will be key for success in 2026.

How will plans to rework medicines legislation in the European Union impact drug development, innovation, and market exclusivity?

Executive Director Emer Cooke presents EMA’s achievements for the year.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

The authors detail a practical application of specification equivalence to excipients testing to achieve in-house harmonization.

Life sciences is a decade behind other industries in its optimization and strategic exploitation of data. This is perplexing, given how much companies profess their ambitions to exploit AI. An industry podcast brought together life sciences thought leaders to debate the subject. The panelists noted that really, by now, standardized data should be yielding greater intelligence, and powering pharma’s future, accelerated by AI. If only companies could find new momentum to finally sort out their underlying data. This article sets out some of the key points that arose from the panel.

FDA leadership initiated rapid drug review programs, enhanced transparency by publishing decision letters in real time, and strategically integrated AI into agency operations.

The approval was granted to USAntibiotics, with FDA saying it addresses pronounced antibiotic shortages in the past two decades.

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

David Basile, VP Technical Operations, Americas, Hovione, explains what regulators expect for the maintenance of GMP facilities and equipment.

The articles in this issue reflect an industry in transition, committed to innovation while ensuring safe, reliable, and forward-looking pharmaceutical production.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing.