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Serialization & Traceability Video Outline
The Astellas Global Serialization Program:
Deterring Counterfeit Drugs and Protecting Patients
As part of the effort to combat the serious and growing problem of illegal counterfeit drugs and rebate fraud, many national governments have been taking steps to enact serialization laws for the pharmaceutical industry.
Astellas responded quickly with a comprehensive global serialization program to ensure compliance with these new legislative mandates and continue its deep commitment to protecting patients worldwide.
There are two broad classes of serialization laws.
The US Drug Supply Chain Security Act (DSCSA) is an example of a “track and trace”, law whereby partners in the supply chain are required to pass serialization data to their downstream partners.
This law mandates that all manufacturers provide packaging with serialization from 27 November 2017. Wholesalers are required to handle only serialized products from 27 November 2019; repackagers from 27 November 2020. Full electronic track and trace capability for all partners in the supply chain is required as of 27 November 2023.
Supply chain partners can check with their upstream trading partners, ultimately to the manufacturer, to determine whether products in their possession have valid serial numbers.
The European Falsified Medicines Directive (FMD) is an example of an “authentication” law. It requires manufacturers to provide serial numbers to a central European Hub database.
The European Hub provides the serial numbers to national databases that are, in turn, connected to dispensers, such as pharmacies, hospitals, and physicians’ offices. Dispensers in each country in the European Union can query their national databases to determine whether the serial numbers on products in their possession were, in fact, issued.
This law further mandates that serialization data recording, along with tamper evidence packaging, be in place by 09 February 2019.
By end of 2016 there were laws governing serialization worldwide including the US, European Union, India, Argentina, China, Saudi Arabia, South Korea, Iran, and Turkey, which covered 50% of the world’s population.
Including countries that are in the process of drafting or implementing laws, Brazil, Egypt, Jordan, Malaysia, Russia, Taiwan, Libya, Oman, Pakistan, Ukraine, Albania, Canada, Colombia, and Mexico, serialization laws would cover two-thirds of the world’s population in the next few years.
Astellas’ global serialization manufacturing process is the same for both “track and trace” and the “authentication” model laws. It is broken down into four levels, as defined by the ISA-95 standard. The highest level is the Astellas serial number repository system, referred to as Level 4 or L4.
The L4 system provides and retains records of randomized serial numbers for all Astellas products packaged by Astellas plants or Contract Manufacturing Organizations (CMO’s) and shipped through third party logistics providers to wholesalers worldwide.
The next level is the plant or CMO plant serialization control system referred to as Level 3 or L3.
Each plant or CMO, in turn, provides a set of serial numbers for specific product runs to the appropriate packaging lines. The line level control system is referred to as Level 2 or L2
The Level 1 or L1 technology on the packaging lines engraves or prints a 2D matrix code containing the serial numbers on each saleable unit of product Any packages with codes that fail to meet standards for readability are rejected.
…Each product bundle, case, and pallet is also serialized if required.
The packaging lines report the serial numbers that were commissioned, that is, successfully applied, to the packages, bundles, cases, and pallets to the plant’ Level 3 system …
The L3 system then sends the commissioned serial numbers to the Astellas L4 system for retention and reporting in accordance with the various serialization laws.
Serialization touches on dozens of countries, with thousands of Stock keeping units (SKU’s), control of billions of serial numbers, impacting hundreds of trading partners, and millions of patients worldwide.
Counterfeit drug and rebate fraud undermine confidence in product safety while putting lives of patients worldwide at risk.
Astellas is committed to this broad-reaching business initiative and understands the important role it plays in Astellas’ culture and operations in reinforcing a patient first approach.
Changing Tomorrow Together
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