Quality Systems

Articles

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

EMA Warns About Falsified Ozempic Pens

Meg Rivers is the former senior editor for 

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Serialization and Aggregation from a Manufacturing Perspective

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Regulatory | Part 4

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Software and Data Management | Part 3

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

New equipment meets needs for faster vial labeling and RFID for unit-level serialization.

Trends in Vial Labeling Equipment

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Packaging | Part 2

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Manufacturing | Part 1

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The Real Danger of Substandard and Counterfeit COVID-19 Vaccines

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

Cybersecurity Vulnerabilities Affecting Drug Manufacturing Equipment

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

Anticounterfeiting, Track and Trace Systems