Issue link: https://www.e-digitaleditions.com/i/331259
ACG Serialization Suite Coming Soon... Your Proven Strategic Partner Since 1977 28115 Lakeview Drive Wixom, MI 48393 248•486•0045 (ph) 248•486•0886 (fax) • Place a machine-readable, matrix code on each individually dispensable package of drug product. The code will represent a secure, randomly generated, unique identification number that will follow that unit to its final destination. An automated system will record the new package and its new iden tification number. • Place that uniquely identified package into a shipper carton of the size and design you prefer, along with the number of sibling packages that you assign to the shipper. The system will "take attendance" in the shipper by reading the unique identification numbers and assigning them to their new container. The shipper will be closed and labeled with both human- and machine-readable documentation that will allow it to be tracked to a pallet that meets your shipping specification. • Give each pallet of product its own equally informative label that will relate to a data package as sembled for your entire batch. • Assemble an electronic data package for your batch that contains the previously assigned identity of the product you shipped to me and that records its chain of custody from my dock to your truck. That data package will be compatible with industry systems and will present the identification of each individual package, the shipper, its siblings, and the pallet identification. I will provide that data package to you in whatever industry-compatible format you select. I know what you're thinking: "That was the easy part!" And you're right. But the rest of track and trace is up to you. www.futurepak.com "Can you take care of my track-and- trace responsibilities?" My response to this question is a question: What responsibilities are you asking about? I'm not sure that I understand yet what the different responsibilities are or whose they are. In fact, I don't think the FDA really knows. Here is what I am prepared to do: Sourcebook_PBE-CCR 6/10/14 1:29 PM Page 29