An industry consortium has recently released the first chapter of a blueprint to help guide the pharmaceutical industry in setting up electronic systems to track their products through the supply chain.
The PDG Blueprint was released by the Partnership for DSCSA Governance (PDG), a consortium of more than 60 pharmaceutical supply chain members that was chosen by FDA to pilot data architecture systems for tracking products. The Drug Supply Chain Security Act (DSCSA) of 2012 requires manufacturers to have such systems in place by November 2023.
Drug traceability is a “highly technical and detailed topic” and DSCSA leaves many of the details of implementation to industry and FDA, it said.
According to a PDG paper presented to FDA, robust systems will be needed by trading partners by the 2023 implementation date, since these systems will then be populated with “tens of trillions of records” which will have to be searched when identifying and tracing drug packages.
The first chapter of the blueprint, released on 14 July, addresses requirements for the exchange of serialized transaction information, product identifier verification, product tracing, and credentialing trading partners.
The chapter “defines baseline business requirements that frame the general systems and processes for implementation of the main components of the DSCSA: secure, electronic, interoperable systems and processes for the exchange of serialized transaction information (TI) and transaction statements (TS), secure, electronic, interoperable systems and processes for product-identifier verification, and secure, electronic, interoperable systems and processes for tracing.”
It took the group a year to develop the blueprint; future chapters are forthcoming. Members include innovator and generic companies, large and mid-size wholesale distributors, third-party logistics provides, and pharmacies.
“The blueprint is the result of a complex and collaborative effort to put forward requirements and recommendations for 2023 interoperability, including identifying what is needed for industry stakeholders to efficiently, reliably, securely, and interoperability work with other stakeholders in the supply chain, verify product, trace the chain of product ownership at the unit-level, and ensure overly supply chain integrity,” said Michael Mazur of Pfizer, one of its members.
Eric Marshall, the executive director of PDG, told Focus that PDG will be hosting a few upcoming workshops to delve into the blueprint, and will be working on the next chapters which will focus on the “overarching governance model” and “additional process specifications to support defining how business requirements can be implemented.”
FDA issued a draft guidance in May laying the groundwork for the data architecture systems needed to build electronic, interoperable systems by the 27 November 2023 deadline called for in DSCSA.
To continue reading this article please go to RAPS .