DSCSA (also known as Track and Trace) is a non-funded government mandate that is rolling out in three phases that began in 2013 and is on schedule to be fully mandated by 11/27/2023. Advasur 360 Compliance Services is a comprehensive suite of Drug Supply Chain Security Act (DSCSA) services that will help you with all current and future DSCSA requirements.
FDA COMPLIANCE — TRACK AND TRACE
DSCSA Compliance
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Goals of the Drug Quality and Security Act
The System will:
- Facilitate the exchange of information by trading partners at the individual package level
- Improve efficiency of recalls
- Enable prompt response to suspect and illegitimate products when found
- Create transparency and accountability in the drug supply chain
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Summary of the Planned Implementation Timeframes for the DSCSA
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What Is Serialization
and What Does It Mean to the Pharma Industry?
In the U.S., the Unique Product Identifier (UPI) consists of:
A National Drug Code (NDC) or a Global Trade Item Number (GTIN)
A Serial Number (alphanumeric up to 20 characters)
A Lot Number
An Expiration Date
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Serialization Challenges For Dispensers
Timeliness: If you cannot achieve serialization compliance in time, you put your whole business at risk Productivity: Central configuration and prequalification reduce impact on OEE and speed up deployment Connectivity: Serial numbers, master data and event information need to be exchanged among supply chain parties and also reported in a compliant way. Communication: Serialization implementation requires the coordination of numerous internal and external stakeholders. Don’t underestimate the scope of your project! Serialization and Beyond: when choosing your serialization solution, don’t forget to consider future compliance and regulatory requirements. Beyond compliance, think of the business potential of your serialization data.
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