Serialization Featured Articles

  1. DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box

    The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?

  2. Serialization And Aggregation Requirements In Russia

    Russian President V. Putin signed Federal Law No. 488-FZ, which deals with the amendments to the “Principles of State Regulation of Trading Activities in the Russian Federation”. This article outlines the labeling and management of track and trace data requirements of the new law.

  3. FDA’s First DSCSA Warning Letter — A Closer Look

    The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.

  4. FDA’s DSCSA Pilot Project Program — Should You Participate?

    The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?

  5. Transforming With An Equipment Partner: Preparing The Industry For Serialization

    Factors to consider as your organization works to conform to the serialization guidelines.

  6. Serialization: A Road Map To Compliance

    Still looking for a serialization solution? In this case study, one contract packaging company took a different mindset and embraced the benefits of track-and-trace capability.   

  7. What Does The Deferment In The DSCSA Deadline Enforcement Mean For You?

    Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.

  8. Understanding And Delivering Your EU Orphan Drug Launch

    Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.

  9. Laser Coding — A Technology Of Choice For The Pharmaceutical Industry

    Has laser coding reached its limits? No. This paper provides evidence and demonstrates that there is still huge potential for laser coding to remain the ideal choice in the pharmaceutical sector.

  10. 5 Benefits Of Item-Level Serialization For Pharma

    Item-level serialization gives each box or bottle of medication its own identity. This can be tracked at every stage of the supply chain – from the production line to the pharmacy and right through to the patient. This enhances the sense of ownership you have with your products, a marker of authenticity that verifies the quality of the contents. Any queries or complaints from pharmacy staff, medical professionals or patients can be traced right back to the individual box.