Manufacturing

Articles

The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.


FDA Pushes DSCSA Serialization Enforcement Deadline to 2018

A survey from The Pistoia Alliance found that just under a quarter (22%) of life-science companies are already using or experimenting with blockchain, but industry collaboration on security and storage standards is needed. 

Survey Reveals that Blockchain will be Adopted Within Five Years

In a new research conducted by SEA Vision and Zenith Technologies, 28% of respondents identified technology selection as the biggest challenge as the industry prepares to meet serialization deadlines. 

Technology Selection Marked as the Biggest Hurdle in Serialization Compliance

Sanjay Sarma is co-founder and research director at Auto-ID Labs, Massachusetts Institute of Technology (MIT). He is also a keynote speaker at NEXUS 17. 

The author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.

Working Smarter: Establishing an Effective Serialization Architecture

The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.

UPS Opens New Healthcare Facility in Colombia

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

Agnes Shanley is senior editor of Pharmaceutical Technology.

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

Synchronizing Anticounterfeiting Efforts

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Survey Suggests that One-Third of Pharma Companies Aren't Ready for Serialization

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

Kirk Randall is sales director of Cryoport.

The complex packaging and logistics required for personalized medicine pose significant challenges, but proactive planning can help ensure success.
