Quality/GMPs

Meg Rivers is the former senior editor for 

Editor of Pharmaceutical Technology Europe

Chris Spivey is the editorial director of 

Articles

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

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

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

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.

EMA Endorses Track-and-Trace Recommendations

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

Track-and-Trace Progress Benefits Supply-Chain Security Efforts

FDA, US Customs and Border Protection, and the US Immigration and Customs Enforcement, Homeland Security Investigations signed a Memorandum of Understanding to prevent illegal drug imports from entering the US through International Mail Facilities.

Anticounterfeiting, Track and Trace Systems