Sovereign Pharmaceuticals Becomes First Manufacturer to Earn All GS1 EPCIS Trustmarks for FDA DSCSA Interoperability Mandate
EPCIS is a GS1 Standard that enables trading partners to share accurate and detailed information about the physical movement and status of products.
PORTSMOUTH, N.H., Feb. 25, 2021 /PRNewswire-PRWeb/ -- Drummond Group LLC, a trusted leader in software compliance and interoperability testing, today announced validation of Sovereign Pharmaceuticals' implementation for compliance to all seven GS1 US Rx Electronic Product Code Information Services (EPCIS) Conformance Testing scenarios for manufacturers. With Vantage Consulting Group's guidance as a key partner, Sovereign utilized QU4RTET 3.0 to meet the requirements of the Drug Supply Chain Security Act (DSCSA) that ensures the U.S. Food and Drug Administration (FDA) and law enforcement agencies may securely detect stolen, contaminated or counterfeit drugs. In 2020, Vantage first completed Drummond EPCIS Cerification testing of QU4RTET 3.0, an open source application, also using Drummond's GS1 Certified EPCIS Compliance Testing Service that was used to validate Sovereign's implementation of QU4RTET.
EPCIS is a GS1 Standard that enables trading partners to share accurate and detailed information about the physical movement and status of products. As a voluntary program designed to support pharmaceutical organizations implementing EPCIS for DSCSA and traceability pursuant to the GS1 US Implementation Guideline, the GS1 US Rx EPCIS Conformance Testing Program supports interoperable EPCIS baseline functionality for the purpose of serialized item data exchanges.
Drummond is an approved GS1 conformance testing partner and its automated conformance test tools enable organizations to assess their EPCIS messages for compliance with the DSCSA rule. Successful completions allow companies to receive a GS1 Trustmark indicating their conformance to the DSCSA messaging requirements.
"As the first drug manufacturer to earn all seven GS1 Trustmarks, we are in a strengthened strategic position to help drive operational efficiencies and deliver secure traceability across our supply chains," said Paul Hafey, Sovereign Pharmaceuticals President. "Utilizing Drummond's highly intuitive EPCIS Interoperability Conformance Checker, a web-based portal tool, was key to gaining the GS1 Trustmarks with speed and efficiency."
"Vantage has a proven history in using innovation to guide pharmaceutical manufacturers on the path to achieving FDA DSCSA track and trace interoperability requirements," said George Poltorak, Vantage Consulting Group CEO. "Sovereign's installation and integration of QU4RTET helped them fulfill the DSCSA's interoperability mandate requirements coming due in 2023. Vantage is committed to effectively and efficiently helping customers meet these very important requirements through the implementation of GS1 standards and the GS1 EPCIS Trustmark program. We are proud of our collaboration with Sovereign as it marks this milestone as the first to earn all manufacturer GS1 EPCIS Trustmarks."
"We congratulate Sovereign for being the first pharmaceutical manufacturer to mark this unique goal," said Aaron Gomez, Principal, Drummond's Supply Chain Security business unit. "In partnership with Vantage Consulting, Sovereign's efforts, commitment and support of GS1 Standards, specifically EPCIS 1.2 for serialized interoperability enables trading partners to share information about products' movements and status throughout the supply chain from one business to another and to consumers. Successfully passing all seven GS1 EPCIS Conformance Testing scenarios is a major accomplishment. Drummond commends Sovereign and Vantage on this partnership and success."
All pharmaceutical supply chain stakeholders seeking additional information about the FDA's DSCSA mandate and Drummond's commitment to the GS1 EPCIS Conformance Program may email: [email protected] – Inquiries on how to gain trial access and request demonstrations also welcomed.
About Drummond
Drummond offers a comprehensive suite of services (including GS1 GDSN Data Pool Certification Testing), to help you achieve compliance with regulatory information security mandates and ensure critical business applications meet interoperability and application conformance. Increase trust, gain expertise and experience our proven methodologies and attention to detail as we partner with you for your long-term success. For more information visit: drummondgroup.com
About Sovereign Pharmaceuticals
Sovereign is a privately owned and operated, full-service, contract development and manufacturing organization established in 1990. Sovereign is central located in Fort Worth, Texas, and occupies a 146,000-square foot facility encompassing a cGMP production area, cGMP QC laboratories and an R&D facility. Sovereign specializes in developing and manufacturing oral tablets, oral capsules, oral and topical solutions, and oral suspensions. Sovereign's committed team of employees excels in cGMP compliance and is focused on customer service by delivering high quality products at a competitive price in a timely manner.
About Vantage Consulting Group
Vantage is the manufacturing productivity company. For manufacturers facing safety, quality, or efficiency challenges, we provide strategic guidance and cost-effective execution of initiatives to improve serialization, packaging, inspection and more. Our team is seasoned, lean, on time and within your budget. vantage-cg.com.
Media Contact
Olga Finneran, Drummond Group, (877) 437-8666, [email protected]
SOURCE Drummond Group
