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Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017.  Ultimately, the FDA recognized the massive undertaking of such a requirement and extended the deadline to November 26, 2018.

Alcami began implementing serialization in 2015 to achieve the aggressive timelines and develop the necessary documentation needed to meet compliance. This case study shows how Alcami has successfully transferred clients into the new serialization program.

Scope of the Law under the Drug Supply Chain Security Act

  • Refers to any prescription drug in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution)
  • Product tracing information should be exchanged for each transaction
    • Transaction information (TI) (which includes lot number of product, except for certain wholesale drug distributor transactions)
    • Transaction history (TH)
    • Transaction statement (TS)

Alcami began working on the transition to serialization in 2015 in order to achieve aggressive timelines and develop compliant formats and documents.

Challenges and Milestones

  • Resources, such as time and capital, to establish a strong serialization program
    • New space within the packaging facility was reconfigured to install new equipment for the bottling and vial lines with minimal disruption to critical timelines
  • Due to different packaging configurations (i.e. bottles vs. bottles in cartons, shippers), each new product requires a performance qualification and a large number of documents associated with the serialization upgrade
  • Partnering with TraceLink Inc. (a cloud‐based company to provide client owned data) and working directly with our clients for the transfer of the Global Trade Item Number (GTIN) to help product traceability and combat counterfeit products
Serialized commercial batch line

Partnering with Alcami

Although the FDA extended the timeline for serialization, Alcami set the goal of completing the process by November 2017. This has given us an edge in the market–ensuring our clients’ products are fully qualified and validated for commercial release. Our current clients have been enthusiastic with our efforts, documented by successful audits and inspections, as well as past experiences and milestones with their products.

Where Are We Now

Through great effort, dedication, and experience, Alcami has developed a cohesive serialization program for our clients. We have successfully transitioned several of our clients into the new serialization program and expect to have additional clients fully qualified by the end of the second quarter of 2018.

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