Pharma traceability technology appears to be taking a small step backward, in order to make a big leap forward in the future as end-to-end traceability of pharma packages becomes a nearer-term regulatory goal. The backward step (a characterization which advocates of the technology can certainly dispute) involves a new standard, “Packaging Serialization Specification 1.0” (PSS 1.0), just ratified by the Open-SCS Group, a consortium of IT and serialization equipment vendors, plus a few Big Pharma companies.*
PSS 1.0 aims to resolve communication variations among IT systems handling Level 3 (plant or distribution center sites) and Level 4 (corporate enterprises) for four common use cases:
- Serial number provisioning
- Serialization report transmission
- Batch & master data repository
- Unused serial number return.
To date, the IT traceability systems of such vendors as TraceLink, Systech, SAP and others have their own methods for carrying out these functions; it is easy to envision a scenario where serialization systems of different vendors co-exist under one enterprise, or—a common situation—where the serialization processes being carried out at a contract packaging organization need to be communicated to the enterprise client of the contractor. In theory, having a common standard for these communications will simplify the implementation of serialization systems, reducing implementation costs and give packagers more flexibility in mixing and matching the various IT solutions. Vendors are also looking at a global serialization mandate, where various countries are putting their own spin on what data needs to be reported to whom.
PSS 1.0, according to announcements at late September’s Pack Expo meeting, will be formally issued in November, and will include functional specifications, IQ/OQ templates, a validation test and a certification plan, among other elements. The working group is finalizing documentation, running a multi-vendor test and setting up the certification program. “This important announcement follows more than two years of committed collaboration by our technical group,” Marcel de Grutter, executive director of the Open-SCS Group (and an IT manager at Abbott). “I would like to thank all the team members who dedicated so much time and effort to this initiative, often working far more than their allotted hours. Now that the initial standard is released, we are hoping for its expedient adoption across the industry: that will be our next challenge.”
Open-SCS is not done, by any stretch. Plans are already in place for PSS 2.0, intended to address communications issues between Level 3 and Level 2 (the packaging line; i.e., controllers and smart devices on the line). Use cases are still being determined; presumably, this standard will encompass nagging serialization issues like parent-to-child relationships among serial numbers (e.g., when multiple units are aggregated to a single case). PSS 2.0 is scheduled to arrive during 2018.
Many packaging lines have serialization systems, and the enterprise-level communications systems, already in place; it is to be hoped that the various vendors involved can quickly bring their systems up to speed in line with the new standard. FDA delayed the official start date of having serialized product available from November 2017 to a year later; now it’s a question whether industry will be ready at that time.
Open-SCS proudly touts the fact that it has coordinated its activities with the GS1 organization (the originators of the EPCIS standard for exchanging serialized data, among other things), ISPE (International Soc. of Pharmaceutical Engineers) and the International Soc. of Automation (ISA; ISA is the origin of the various “levels” of industrial automation referenced above). Undoubtedly, such coordination is necessary; nevertheless, it points to the diversity of interests (both in business and in technology) that have a say in what serialization will do in pharma distribution. The overlap with GS1’s EPCIS standard is especially cause for concern: industry participants spent years developing the standard, and there is some friction with how it has been implemented by vendors and how interoperable it is. Brian Daleiden, VP of industry marketing at TraceLink, says that there is a “synergy” between EPCIS and PSS 1.0. Dirk Rodgers, regulatory strategist at Systech International, says that EPCIS is mostly about data-sharing between trading partners, while PSS 1.0 handles data moving up and down in the packaging process.
Supply chain or packaging managers contending with serialization now not only need to worry about PSS 1.0 certification; they also have concerns with how the packaging line technology interacts with warehouse management systems and other logistics processes. At the other end of the supply chain—hospitals and pharmacies that receive pharma products—there is talk of coordinating serial data with the electronic health record (EHR) systems now in use at many facilities. In between the manufacturer end and the dispenser end, there will be manufacturers and distributors who note that the Drug Supply Chain Security Act (the 2013 US law that mandates traceability) does not specify EPCIS data-sharing (ditto with, now, PSS 1.0) and will present exceptions to the overall tracking framework. And all this is occurring in an environment where serialized and non-serialized product will co-exist in the supply chain for years to come.
All that being said, the Open-SCS group represents progress in establishing serialization technology. Customers of this technology will do well to check the certification status of their vendors going forward.
*There are 25 members currently: Abbott, ACG Inspection Systems, Adents, Advanco, Antares Vision, Arvato Systems GmbH, ATS Global, FacilityBoss, Giesecke & Devrient, Laetus, Mettler Toledo PCE, Omron, Optel Vision, Pfizer, Roche, Rockwell Automation, SAP, Systech International, Tradeticity, Teva, TraceLink, Uhlmann, Vantage Consulting, Werum, and Wipotec-OCS.