August 1, 2016 PAP-Q03-16-CL-012
Essentially, serialization is the assigning of a predetermined coding type to each product item, conferring it with a unique identity that allows it to be effectively tracked at virtually any moment, and traced to its location at any stage of the production, logistics and/or marketing chain it is currently involved in, or had been involved in at any point during its life cycle.
A number of reasons help explain what makes product serialization beneficial, especially for high-volume, easily counterfeited parenterals. Serialization at the unit level allows Grifols and its Grifols Partnership customers to:
In order to serialize products, Track & Trace systems tied to the company’s IT infrastructure are used. A serialization and aggregation system implemented by Grifols and Grifols Partnership allows parent-child relationships to be established between the different geographic locations of Grifols packaging facilities throughout the production process — primarily during packaging processes (in Grifols’ case, vials, single packs, multipacks and pallets).
Grifols’ serialization and aggregation systems and process make it possible to carry out track and trace operations at virtually any moment, not only in the supply process, but also during the logistic and marketing processes undergone by Grifols products, as well as those produced by Grifols Partnership for its customers. In addition to Grifols’ internal processes that include the relationship between the levels of serialization by product continent and the potential traceability throughout all aforementioned processes, the Grifols system offers the following:
Track & Trace systems adhere to a five-level model, where each of the levels described below is interconnected and come together in a tree structure:
Our experience implementing a serialization solution for products manufactured by Grifols enables us to offer this service in projects undertaken for customers of Grifols Partnership. Grifols’ Contract Manufacturing division is working hard in this regard in order to help customers comply with the Drug Supply Chain Security Act (DSCSA) by November 2017.
Requirements for the serialization of products to be distributed in the USA are stated in the DSCSA corresponding to Title II of the Public Law 113-54 published by the agency in November 2013 and include:
Product Identifier and Product Tracing
Both requirements have different timelines that are exposed hereinafter:
a. Product Identifier: A code composed by the Standard Numerical Identifier (unique ID for each product) + Batch number + Expiry. The implementation could be made by means of a data matrix code or a linear barcode (depending on the product final packaging configuration). Data shall be codified as well as shown in a human readable form. Product identifier shall be implemented by November 2017.
b. Product Tracing: This point refers to the fact that for all product transactions (understanding a transaction as the change in ownership of a product), the emitting entity shall provide the receiving entity with certain information. This information includes: transaction information, transaction history, as well as a transaction statement. Product Tracing shall be implemented in paper format (as a minimum requirement) or electronic format by January 2015 and in electronic format in November 2017.
Grifols currently has two Track & Trace systems in place for the serialization and aggregation of hemoderivative products. These systems are:
This system currently covers levels 1, 2 and 3, as defined in the Track & Trace systems model, both at the single-pack and multipack levels of the product. At this time, the project is still live, and the implementation of levels 4 and 5, as defined in the Track & Trace systems model, is in progress both at the pallet level and, at a future date, at the vial level of the product.
Our experience implementing serialization solutions for Grifols’ broad range of sterile solutions, plasma and related parenteral products enables us to offer this service in projects undertaken for customers of Grifols Partnership. Grifols Contract Manufacturing division is working to help its customers in this regard in order to help them comply with the Drug Supply Chain Security Act (DSCSA) by November 2017. With well-integrated technologies and systems, Grifols is ready to reap the continued benefits of Track & Trace and deliver similar capabilities to its contract manufacturing partners.
Pere Vilanova studied computer engineering at the Universitat Oberta de Catalunya. He possesses Master’s degrees in quality control techniques, quality control engineering and management, SAP finance and controlling. With almost 22 years’ working in different Grifols companies (Diagnostic Grifols, Laboratorios Grifols, Grifols IT, Grifols Worldwide Operations in Ireland) and having experience in production, quality control, validations, engineering, Track and Trace systems and IT areas, Vilanova is currently heading the new IT Technology Development Area. He is mainly focused on RFID, 3D printing, industry 4.0, IoT, big data and Manufacturing Execution System projects.