Astellas global serialization

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Project Main Details

Astellas global serialization 
ZD1888344
Internal communication tool for pharma company. Two videos one 500 words the other 635. Looking for quick turnaround. Fairly straight forward read. Can link to rough cut of video for reference. Script broken down into smaller sections for easy pacing 
2017-01-25 18:04:52 GMT
2017-01-26 11:00:00 (GMT -06:00) Central Time (US & Canada) 
Yes (click here to learn more about Voice123's SmartCast)
Closed
2
2
2 direct invitation(s) have been sent by the voice seeker resulting in 1 audition(s) and/or proposal(s) so far.
Voice123 SmartCast is seeking 10 auditions and/or proposals for this project (approx.) Invitations sent by SmartCast have resulted in 1 audition(s) and/or proposal(s) so far.

Project Parameters

The Voice Actor should be located in:
Flexible Price - USD 400 to USD 600
Training, business presentations, sales, and web sites
No
4 MINUTES
English - South African
Lara Logan 60 minutes reporter
Middle Age Female
• Phone Patch OR
• Audio files must be delivered via email OR
• Audio files must be delivered via FTP/Dropbox/Google Drive/cloud
There are no special pre-, post-, or production requirements for this project.
Not defined
The voice seeker is willing to hire either union or non-union talents for this project

Script Details

Yes
N/A 
Astellas Pharmaceutical
Serialization & Traceability Video Outline
Video One

The Astellas Global Serialization Program:
Deterring Counterfeit Drugs and Protecting Patients

Introduction

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.

Laws

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.

The Process

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.






Closing

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 
Please note that you should only use the script or your recording of it for auditioning purposes. The script is property, unless otherwise specified, of the voice seeker and it is protected by international copyright laws.

Voice-Seeker Details

118002
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2017-01-25
1

5


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