TraceLink's Elizabeth Waldorf discusses how GS1 standards - and particularly EPCIS certification - can help firms wrestling with DSCSA requirements, and introduces a new conformance testing programme for pharma that will be rolled out later this year.
Hundreds of thousands of life sciences companies rely on GS1 US, today, to optimize trade partner collaboration by leveraging standards for meeting compliance requirements. In order to help the industry prepare for the upcoming US Drug Supply Chain Security Act (DSCSA) serialization deadlines, GS1 US published, in November 2016, a new release of the GS1 US Healthcare Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability (Release 1.2). While feedback on the new implementation guideline from stakeholders across the US pharma supply chain has been positive, the GS1 Rx Secure Supply Chain workgroup recognized that in our efforts to be comprehensive in providing ongoing guidance to the industry, the sheer amount of information can be daunting.
Given my collaboration with the Rx Secure Supply Chain workgroup and 20-plus years working in the supply chain, I am compelled by the need to not only clarify some important misperceptions about applying GS1 standards to DSCSA implementation, but also address a hot topic surfacing since the release of the new implementation guideline: EPCIS certification, and just how relevant it is to the pharmaceutical industry. In this article, I hope to shed some light, as well as provide pertinent details about new and upcoming GS1 materials, including the just released GS1 US Healthcare Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the US DSCSA document, which addresses topics such as:
Applying GS1 product identifiers to meet DSCSA compliance
Defining Location Identifiers with GS1 Company Prefixes
Applying EPCIS to DSCSA
FAQs for a focused approach
GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability (Release 1.2) is the result of two years of concerted effort to harness industry's DSCSA implementation experience and to align the guideline with version 1.2 of the GS1 EPCIS and Core Business Vocabulary (CBV) standards— GS1 Standards that enable trading partners to share information about the movement and status of products as they travel through the supply chain. In addition to the latest release of the guidelines, the GS1 US Rx Secure Supply Chain Workgroup developed a complementary tool in order to bring more clarity around GS1 standards for serialization implementation and data sharing. The GS1 US Healthcare FAQ document, published in May 2017, delivers the content in a more digestible fashion and enables the reader to navigate through it more easily.
As industry completes its preparations to go live with DSCSA serialization requirements for 2017, more and more trading partners are focusing on the journey to item-level traceability starting in 2023.Companies applying GS1 Standards to meet DSCSA compliance may be on track with preparations, but questions linger across the supply chain, such as:
What standard identifiers are relevant for my role in the supply chain?
What's my approach if I have multiple roles in the supply chain, or have a global presence?
With regards to product, how do GS1 identifiers work with National Drug Codes (NDCs)?
When it comes to data reporting to my trading partners, does EPCIS standard satisfy all requirements of DSCSA?
The GS1 US Healthcare FAQs address the most pressing concerns of all parties across the supply chain that are wrestling with what exactly they need to know for DSCSA compliance, which GS1 Standards apply, and what they can filter out as irrelevant to their business.
Applying GS1 product identifiers to meet DSCSA compliance
All parties across the supply chain, not just manufacturers, can benefit at this time from some education on GS1 identifiers. Specifically,
How do GS1 identifiers work with NDCs?
Which identifiers apply to the partner's role in the supply chain? And how will they be utilized by those entities?
The GS1 US Healthcare FAQ document includes sections on all of the various product identifiers, defining how GS1 assigns a GS1 Company Prefix, generates a Global Trade Item Number (GTIN), and how a Serialized Global Trade Item Number (sGTIN) relates to an FDA mandated Standardized Numerical Identifier (SNI).
While preparing to meet DSCSA serialization requirements, many manufacturers are trying to understand the methodology for converting NDCs to GTINs. Some partners are seeking clarification on what exactly a GS1 Company Prefix uniquely identifies, and whether or not a company could have more than one. Some stakeholders are asking what the relationship is between a manufacturer's labeler code and a GS1 Company Prefix. The FAQs cover these questions and more, offering GS1 recommendations for the use of product identifiers as best practice for meeting requirements.
Defining location identifiers with GS1 company prefixes
Applying GS1 identifiers extends beyond products into business entities. By assigning location identifiers to their corresponding business entities, companies can more easily communicate with their supply chain partners. Some questions that get asked are:
How many GLNs can a company create?
Do manufacturers, repackagers, wholesalers, dispensers, contract manufacturers (CMOs), third party logistic providers (3PLs), or contract packagers (CPOs) need GLNs?
What do companies with multiple labeler codes need?
Do companies who operate in the US and in other countries need country specific GS1 company prefixes?
The GS1 US Healthcare FAQs highlight these scenarios and offer particular recommendations for companies with global presence to utilize GS1 Company Prefixes for creating GTINs, GLNs, or any other GS1 identification numbers.
Applying EPCIS to DSCSA
DSCSA requires supply chain partners to capture and share information about transfer of ownership of pharmaceutical products, using standards for interoperable exchange of information. While the law does not specify a particular technology, the Rx Secure Supply Chain workgroup collaborated to develop R1.2 of the GS1 US Implementation Guideline to illustrate how EPCIS can be applied for expressing the DSCSA required information in an interoperable manner.
The FAQs highlight best practice use of EPCIS for DSCSA data reporting referencing implementation guideline examples on relevant EPCIS events, including how product and partner master data can be imbedded in the EPCIS document.
The FAQs emphasize the fact that generating messages that comply with R 1.2 of EPCIS, without making use of R1.2 of the GS1 US Implementation Guideline, is not sufficient. It is imperative that stakeholders follow the specifications provided in the new release of the guideline in order to ensure conformance with DSCSA requirements.
Deciphering EPCIS certification – next steps
Since EPCIS Standard certification is sector-agnostic, obtaining EPCIS certification does not guarantee a complete and correct DSCSA message. In order to ensure pharmaceutical industry conformance to R1.2 of the GS1 US Implementation Guideline, the Rx Secure Supply Chain workgroup is designing a conformance test programme; this is planned to be rolled out by the end of 2017, with programme details coming in the near future. The GS1 US R1.2 Conformance Test Programme aims to lower cost by eliminating iterations due to syntactical errors, reduce implementation time, speed up partner on-boarding, and improve the quality of messages. The conformance test will assess adherence to R 1.2 of the GS1 US Implementation Guideline for proper application of EPCIS in complying with US pharmaceutical DSCSA requirements.
The goal of the GS1 US Healthcare FAQs is to provide a more digestible means for absorbing the comprehensive information contained in R1.2 of the GS1 US Healthcare Implementation Guideline. It is designed as a quick reference tool that enables supply chain entities to easily identify key areas of interest and know where to find greater detail. It is the hope of the Rx Secure Supply Chain Workgroup that the FAQs motivate readers to embrace the entire Implementation Guideline as a playbook towards meeting DSCSA compliance. Beyond adopting EPICS as a standard, conformance to R 1.2 of the GS1 US Implementation Guideline moves the US pharmaceutical supply chain towards regulatory compliance and interoperability.
Elizabeth Waldorf is Director of Global Traceability and Standards, at TraceLink. She is an active member of the GS1 Healthcare US Rx Secure Supply Chain Workgroup, technical co-editor of R1.2 of the GS1 US Healthcare Implementation Guideline, and co-chair of the GS1 Global Traceability Standards2 workgroup. Before joining TraceLink, she led Amgen's global serialization and traceability initiatives, and drove adoption of GS1 standards across the company.