Quality Systems

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.

Counterfeit pharmaceuticals jeopardize public health worldwide, often leading to ineffective or dangerous treatments. Enter Raman spectroscopy: a rapid, non-destructive analytical technique that unveils the molecular secrets of medications. With its ability to identify counterfeit drugs through unique molecular fingerprints—even without unsealing their packaging—this technology is transforming pharmaceutical forensics and safeguarding global health.

Large-language models are excellent for general-use AI systems, but they don’t understand pharmaceutical companies’ proprietary documentation—the validated procedures and quality protocols that ensure drug safety. Smaller, domain-specific language models give companies more control and efficiency in their AI use.

FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis.

Starting with risk mitigation, GMP facility and equipment maintenance is all about anticipating problems before they happen and showing regulators a controlled environment.

The agency is expanding its use of artificial intelligence (AI) with the deployment of agentic AI for staff to create more complex AI workflows and harness AI models.

As advanced manufacturing technologies reshape pharmaceutical production, the Qualified Person (QPs) must evolve from a traditional document reviewer into a digitally fluent leader capable of navigating complex data ecosystems, real-time analytics, and automated control systems. This article presents a holistic framework for “Certification by Design,” highlighting how QPs can ensure compliant, agile, and science-based batch release in the era of Industry 4.0.

The European Union aims to become the most attractive destination for clinical research.

In a poster presentation at AAPS PharmSci 360, Eda Fenercioglu, a scientist at Pfizer, outlines a streamline workflow for identifying and mitigating visible particles in biologic drugs.

Vishal Mukund Sonje, Vaccine Manufacturing Lead, CEPI, talks about the challenges that arise in the manufacturing of vaccines in various global regions.

Pharma companies are focusing on sustainability efforts to meet client expectations, environmental audits, and climate pressures.

Real-world data can be utilized to ensure quality and effectiveness of drug products.

This article outlines common CMC problems that are obstacles that steal momentum and create costly detours in the development or orphan drugs.

The European Union aims to become the most attractive place for life science by 2030.

The increasing diversity and complexity of injectable drug products is driving innovation.

Pharmaceutical Technology® spoke with Juliana Maynard, PhD, Head of Translational Imaging at Medicines Discovery Catapult, to find out what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer.

Siegfried Schmitt, PhD, vice-president, Technical at Parexel, answers questions on the use and benefits of real-world evidence for small-molecule and large-molecule drug development.

A draft reflection paper on patient experience data is up for public consultation until Jan. 31, 2026.

FDA's Center for Biologics Evaluation and Research has released updated draft recommendations for sponsors of cell therapies, gene therapies, and tissue products.

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.

The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal evidence is lacking, observational findings can influence policy and public perception.

EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.