In 2011, I wrote a paper titled,” Beyond the Mandates,” with the intent of outlining how the proposed regulations for mass serialization (imminent for implementation with different global timelines) could provide additional value for overall supply chain visibility. Seven years later, the debate in terms of when and how to implement a combination of mass serialization, wireless networks and event management technology continues with the desired outcome to provide the Holy Grail of Supply Chain Management — real-time visibility across the chain of custody.
The regulations have changed – expanded and become more formal in many areas - but there are still challenges to be met and additional opportunities to exploit.
There is a lot of hype related to the ‘so-called’ Internet of Things (IoT) – which is basically an ecosystem that supports the increasing ubiquity of smart devices, sensors, smart labels (integrated RFID imbedded into human readable and barcoded adhesive labels). At a simplistic level, the “data management, sharing and process facilitation” has moved from devices into a web-based series of applications that are accessible to many trading partners through shared applications and alerting tools.
This technology platform enables the goals expressed by regulators in the life sciences industry of having a digital audit trail for each of the transactions that support the movement of raw materials, API, drug substance, drug product and finished packaged pharmaceutical and biotech products across an extended chain of custody and into the “point of patient” or chain of care.
Additional capabilities that are facilitated by web-based applications relate to the time and state of materials and products with defined workflows and alerting mechanisms enabling proactive intervention for an adverse event. This is especially relevant for the growing number of exploratory compounds and drug products in the evolving biotech industry where most shipments are sensitive to environmental conditions and extremely short shelf lives.
For over two decades, there has been debate about the use of auto-identification technology to create a digital audit trail across the chain of custody for life sciences products. Mandates, initiatives and deadlines have varied, a case in point being the proposed legislation in the state of California for mass serialization for prescription drugs with a timeline that has been extended several times over the past 15 years. This imperative in California has been replaced by more harmonized and extensive regulations, in the form of the Drug Supply Chain Security Act (DSCSA). With a focus on the safety and security of the overall supply chain, and encompassing all states within the U.S., this is an extension of the principles of the Drug Quality and Security Act (DQSA), which was enacted by the U.S. Congress on Nov. 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. (also includes the timeline for compliance). As stated on the U.S. Food and Drug Administration (FDA) website:
“This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually”
The requirements from the FDA mandate are comparable to the initial requirements of the Track and Trace Public Workshop on Feb. 15, 2011. This forum included participation from the California State Board of Pharmacy, reinforcing its commitment to an e-pedigree program and timeline. E-pedigree is an electronic record that charts each transaction involving a change of ownership of a dangerous drug in the manufacturing supply chain lifecycle. The workshop provided attendees with a clear set of requirements in terms of participant requirements that included the definition of:
In addition to the regulations related to the DSCSA that are being planned for implementation over a staged timeframe, there are additional regulations that have been introduced in the European Union (EU). There are more similarities than differences, but the bottom line is that mass serialization is a reality and the time for action is now!
The following is an overview of both regulations:
U.S. – Drug Supply Chain Security Act (DSCSA)
The DSCSA is Title II of the Drug Quality and Security Act (DQSA) that came into force in 2013. The DSCSA defines the implementation model for an interoperable electronic system to authenticate and track marketed prescription drugs in the U.S. By 2023, this will enable serialized traceability for individual packages across the commercial supply chain.
This information is required in three different levels of documentation:
Record of all transactions for movement of product, going back to the manufacturer, in paper or in electronic format.
Transaction statement (TS)
All TI/TH/TS documentation must be retained for six years.
European Union Falsified Medicines Directive
Enacted in 2013, this directive introduced track and trace regulations to monitor and control the safety and supply of medicines for human use. Requirements include:
Serialization – manufacturers must mark packages with four data elements:
Serialization should take place at the secondary or saleable unit to enable product verification across the chain of custody. By law, pharmacy dispensers must verify product identity prior to dispensing. Safety elements, to include tamper-evident packaging and labels, must also be verified.
Reporting – Reporting of product code, lot of batch, expiration date, doses per pack, target market, and serialization detail must be done to the European Medicines Verification System (EMVS) to verify identity of pharmaceutical products for sale in the EU. In some cases, it is also necessary for supply chain partners to perform parallel reporting.
Read Part 2 of this two-part blog series here.
Carla Reed is a supply chain professional with more than 20 years of experience in supplier engagement, manufacturing, emerging market development, outsourcing, global trade, regulatory compliance, storage and distribution. She is a thought leader in supply chain transformation, and has researched, authored and presented a series of white papers related to opportunities and risks across the discovery to distribution lifecycle for life sciences. Her understanding and expertise in material acquisition, management and transformation has been disseminated in white papers, speaking engagements and more recently, in co-authoring the ISPE Operations Guidelines for Pharmaceutical Manufacturing. Her firm, New Creed LLC, provides change leadership to facilitate sustainable solutions, providing hands-on experience in all aspects of supply chain operations. Learn more about Creed at https://www.linkedin.com/in/carla-reed-2b8830/.