Quality Systems

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

Articles

Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations. 

Standardizing Serialization

Agnes Shanley is senior editor of Pharmaceutical Technology.

Internet of things, advanced analytics, and blockchain solutions such as smart contracts promise to give manufacturers more control over products and supply chains.

Real-Time Logistics

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

Drug Supply Chain Tracking Challenges FDA and Manufacturers

TraceLink’s Graham Clark, director of contract supplier relationships and cofounder, and Brian Daleiden, vice-president of industry marketing, shared insights into industry’s serialization readiness as well as recent trends and developments with Pharmaceutical Technology. 

Will Traceability Services Be Outsourced?

Kelly Waters is director of marketing for InstantGMP, Inc.

The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.

Decoding Serialization Regulations

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.

Synchronizing Anticounterfeiting Efforts

Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.

Counterfeiting Loopholes Involve Internet, Mail, and Trade-Free Zones

Evren Ozkaya, Ph.D., Founder and CEO, Supply Chain Wizard, LLC

igital tracking of overall equipment effectiveness can improve efficiency.

Countering the Loss in Efficiency Caused by Mandated Serialization Compliance

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

Serialization Hits the Home Stretch

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.

Anticounterfeiting, Track and Trace Systems