| Greetings!
As mentioned in previous newsletters, the likelihood of serialization regulations emerging globally and the unpredictability of future regulations make it imperative that manufacturers invest in a solution that can quickly and cost-effectively accommodate changes and respond to new demands.
Brazil is the latest example of yet another country implementing legislation requiring serialization. In 2009, Brazil passed Act number 11.903, which requires the "tracking of manufacturing and consumption of medicine by means of data capturing, storing, and electronic transmission technology." In order to comply with these regulations, local and multi-national pharmaceutical companies serving the Brazilian market need to promptly deploy serialization technology.
In this issue we will provide you with an overview of the Brazilian legislation, a practical approach to address the pending Brazilian serialization regulations, an example of how one manufacturer took a strategic approach to serialization, and additional information on how pharmaceutical manufacturers can maximize the efficiency of their packaging operations. I hope that you find this newsletter useful. If you have any comments or suggestions regarding this or future editions, please drop a note to newsletter@systech-tips.com
Regards,
Joseph Ringwood
COO, Systech International |
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Systech and Videojet Brazil Partner to Meet Brazil's Emerging Pharmaceutical Regulatory Requirements | |
Systech International and Videojet Brazil, a leading supplier of encoding and marking solutions recently announced pharmaceutical manufacturers to effectively meet the country's quickly emerging regulatory requirements.
This latest partnership is a testament of Systech's ongoing mission to work with leading OEM's, providers of ERP and EPCIS as well as packaging line integrators and information systems specialists. To date, Systech has partnered with companies such as Marchesini, Domino, Pester Pac, Kepware, Impinj, Axway and Barry-Wehmiller Design Group.
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| Brazil's New Anti-Counterfeiting Regulations Require Item-level Serialization |
 In 2009, Brazil passed Act number 11.903, which requires the "tracking of manufacturing and consumption of medicine by means of data capturing, storing and electronic transmission technology." Also, the National Health Regulatory Agency of Brazil (ANVISA), adopted Resolution RDC No. 59, which mandates that each company.....
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| Meeting the Requirements for Today and Tomorrow |
Brazil is the most recent in a string of countries around the world that have passed, or will soon pass, legislation requiring serialization. The purpose of these legislative actions is to secure the supply chain from counterfeit medicines. The other legislations include...
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A Strategic Approach to Global Serialization Initiatives
Companies with their eyes on the future see current requirements, such as Brazil's Act number 11.903, as strategic opportunities to employ a platform that they can continually leverage when addressing various regulatory requirements. By looking ahead of current requirements and understanding the strategic value of serialization, pharmaceutical companies can prepare for the future....
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| Complying with Brazil Resolution RDC
No. 59 | 
Systech International and Axway, a leading provider of B2B infrastructure and track & trace solutions, recently hosted a webinar for over 60 attendees. The webinar focused on how companies wishing to do business in Brazil will need to comply with Resolution RDC No. 59.
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During the webinar, both companies discussed how to convert Resolution RDC No. 59 into an actionable requirement, and how manufacturer's decisions impact both short and long term cost of compliance. They discussed the following
They also discussed the following:
- An overview of the Brazilian regulations
- A sample of conceptual architecture and key requirements
- A discussion of key contributors for managing cost of compliance projects
If you are interested in learning more about the capabilities of both Systech and Axway, please contact Bruce Harder at:
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