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Agnes Shanley is senior editor of BioPharm International.
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
It was a busy year for the Open-SCS working group. Charlie Gifford, technical director of the group, summarized developments that occurred in 2017.
BioPharm International: How did you decide to use good automated manufacturing principles (GAMP) lifecycle best practices for the serialization standards?
Gifford: The User Requirement Specification (URS) and Functional Specification (FS) for the standard Packaging Serialization Specification (PSS) version 1.0 were approved by members in August. Three member companies are already using them as templates for projects, and providing feedback into ongoing validation testing.
However, in June, we took the International Society for Pharmaceutical Engineering’s (ISPE’s) recommendation and adopted the GAMP lifecycle best practice of conducting a full validation test and report using prototype OPC-UA interfaces in order to refine PSS 1.0’s URS, FS, and operational and installation qualification (OQ/IQ) templates. The new PSS 1.0 package is set for formal release in March 2018, depending on available member resources. Eleven vendor members have committed a developer to build prototype interfaces for the validation test. This design-build-test exercise has already brought out many updates to functional requirements that had not been addressed in the previously approved draft.
In December, work began on a PSS 2.0 URS working draft, which is scheduled for member review in February. Six inter-plant solution providers and two end users are working on this project. Depending on availability of member expert resources in 2018, the technical committee hopes to accelerate and release PSS 2.0 by the fourth quarter of 2018.
BioPharm: What kind of participation are you seeing among pharma companies and contract manufacturing organizations (CMOs)?
Gifford: Membership is now over 25, with 100 interested companies saying that they will join the group, either when PSS 1.0 is released addressing plant operations (Level 3), to enterprise (Level 4) exchange use cases for regulation reporting, or once the PSS 2.0 addresses Level 2-Level 3 exchange use cases.
BioPharm: What have been the most challenging technical aspects of developing this standard? How are they being resolved?
Gifford: One major challenge was dealing with the high-level complexity of the packaging serialization scope and problem data (product, order, reporting) and their associated integration technologies. As we’ve learned after working on these problems for the past 24 months, the root of the problem often lies with pharma customer requirements. Most pharmaceutical manufacturers’ serialization exchange requirements force their vendors to customize GS1’s Electronic Product Code Information Services (EPCIS) schema into forms that are not interoperable across systems. These interfaces don’t scale, corrupt good data, and do not apply required interoperable transaction methods. GS1’s EPCIS experts have worked directly with our team to ensure that the PPS 1.0 [specifications for each use case] comply with EPCIS, or at least are as closely aligned as the scope permits.
Because EPCIS’s scope does not address serial number management and serialization events between the packaging plant and enterprise, another major challenge was developing a Serialized Identifier (SID) event lifecycle model for the events, states, and transition for serial number management and serialization events between the packaging plant and enterprise. Along the way, we’ve had to respond to the challenge that any new collaborative organization faces: how to fund all this work. We are still working to find the best business model that will support new projects and updates from changed and new regulations.
BioPharm: How difficult has it been to establish consensus among members from such different groups?
Gifford: It was especially challenging during 2015 and 2016, when there was a great deal of debate on whether PSS 1.0 should address data exchange between the site serialization manager-actor (Level 3) and the enterprise serialization manager-actor (Level 4) or between the packaging line serialization manager-actor (Level 2) and Level 3. We held four workshops on this topic alone during that period.
BioPharm: How difficult is it to get the high-level IT help that serialization and traceability programs demand?
Gifford: Hiring skilled developers, for the funding that is available, is a challenge for all manufacturing and business sectors, especially as Manufacturing 4.0 initiatives take shape. Integration-specific developers are a rare breed. They need to have over five years of experience and mentoring in order to be competent enough not to compromise data accuracy and security. This challenge has dramatically affected the quality of serialization solutions deployed in the life-sciences industry. Having a standardized integration approach will significantly reduce risks.
At this point, though, life-sciences companies are not openly acknowledging and reacting to the supply of talent. For example, the going hourly pay rate for developers with the necessary skills has increased to $180-200 per hour. Pharma companies are paying $80-120 per hour, so many developers in life sciences get serialization experience and additional training and leave the sector for better-paying jobs elsewhere.
BioPharm: What have you learned from the pilot tests?
Gifford: We achieved a number of benefits by using OPC Universal Architecture (UA), which allowed us to find and fix holes in the original draft standard specifications. We used UA to develop the validation test, FS, and associated OQ and IQ modules. The validation tests have provided a foundation for certification programs, and, as previously mentioned, solutions providers are participating in the validation test by developing interfaces.
BioPharm: What are you planning for the next phase of this work?
Gifford: We began working on a draft of the PSS 2.0 URS in December for review by members in February or March. The approved scope of this standard specification will extend use cases for serial number provisioning and return as well as serialization master data, and event reporting.
It will also address use cases for rework and multistep processing and incorporate new use cases determined through customer surveys and an April 2017 workshop, including serial number provisioning for lot start; end-of-lot issues such as unused serial number returns and unused, decommissioned, orphaned, or sampled serial numbers; end-of-lot issues with full batch data and mid-lot runs; production order downloads for new and rework orders, including aggregation hierarchies; and handling exceptions.
Vol. 31, No. 1
When referring to this article, please cite it as A. Shanley, "Moving Toward Open Standard Specifications for Serialization Integration," BioPharm International 31 (1) 2018.