pharmaceutical serialization: track & trace in the usa
TRANSCRIPT
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Pharmaceutical Serialization: Track & Trace in the USA
Aisha NabiyevaDavid Wu
Advisor: Bruce Arntzen
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How do we implement Serialization?Translating theory….
• Supply Chain Traceability across all echelons
• Hampering pharmaceutical counterfeiting efforts
• Discouraging drug theft
• Improving visibility to source of vendor returned inventory
…to Reality
• Installation of necessary hardware and software
• Design processes to identify and seize counterfeits
• Incorporating loss-identification process into track & trace
• Adding the reverse supply chain to Serialization
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DSCSA Timeline
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Manufacturer will set the baseline for future serialization
• Nov 2019
• All Distributors will need to achieve 100% traceability of pharmaceuticals in their ownership
Manufacturers Distributors Dispensers
• Nov 2020
• All Dispensers will need to achieve 100% traceability of pharmaceuticals in their ownership
• Nov 2017
• All Manufacturers need to place individual serialized code on their products
• Serial information needs to be stored in secured database
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Success depends on overcoming the following challengesChallenges Description
SerializationHardware
• The capital equipment necessary to print and scan the serialized labels needed for serialization – includes both unit level and aggregate level equipment
Serialization Database • The database required to house all serialization data
TI/TH/TS Transmission
• The data capture and exchange process needed to ensure traceability across all supply chain echelons
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Compatibility of both hardware and software need validatedChallenges Potential Roadblocks Decision Needed
SerializationHardware
• Lack of compatibility with existing line equipment
• Insufficient speed/robustness to maintain output
• Installation difficulties
• Specification of necessary hardware capabilities
• Standardization of installation process
Serialization Database
• Robustness of database under heavy load
• Data Security• Data Integrity
• Specification of database size,scalability, security
• Codification of data management processes
TI/TH/TS Transmission
• Capture of necessarytransaction information
• Transfer of transaction information
• Codification of best practices to ensure reliable capture and transmission of data
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• Nov 2019
• All Distributors will need to achieve 100% traceability of pharmaceuticals in their ownership
Manufacturers Distributors Dispensers
• Nov 2020
• All Dispensers will need to achieve 100% traceability of pharmaceuticals in their ownership
• Nov 2017
• All Manufacturers need to place individual serialized code on their products
• Serial information needs to be stored in secured database
Distributor will extend serialization capabilities
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Success depends on overcoming the following challengesChallenges Description
TI/TH/TS Transmission
• The data capture and exchange process needed to ensure traceability across all supply chain echelons
Datadisaggregation and aggregation
• The ability for Distributors to disaggregate high level serialization information into unit-level, and vice versa
Serialization Data Manipulation
• The ability for Distributors to manipulate serialization data in the master database regardless of database ownership
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Reliability of data exchange is of highest importanceChallenges Potential Roadblocks Decision Needed
TI/TH/TS Transmission
• Capture of necessarytransaction information
• Successful transfer of transaction information
• Codification of best practices to ensure reliable capture and transmission of data
Datadisaggregation and aggregation
• Efficient and timelydisaggregation of linked-pedigree data
• Ability to re-aggregate serialized units for shipment
• Codification of data disaggregation and aggregation processes
• Standardization of receiving and shipping processes to enable data disagg./agg. process
Serialization Data Manipulation
• Ability to edit and manipulate serialized database if needed
• Codification of best practices to ensure reliable editing of data
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• Nov 2019
• All Distributors will need to achieve 100% traceability of pharmaceuticals in their ownership
Manufacturers Distributors Dispensers
• Nov 2020
• All Dispensers will need to achieve 100% traceability of pharmaceuticals in their ownership
• Nov 2017
• All Manufacturers need to place individual serialized code on their products
• Serial information needs to be stored in secured database
Dispensers will build on existing serialization framework
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Success depends on overcoming the following challengesChallenges Description
TI/TH/TS Transmission
• The data capture and exchange process needed to ensure traceability across all supply chain echelons
Datadisaggregation
• The ability for Dispensers to disaggregate high level serialization information into unit-level
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Dispenser stage will test system-wide serialization robustnessChallenges Potential Roadblocks Decision Needed
TI/TH/TS Transmission
• Capture of necessarytransaction information
• Successful transfer of transaction information
• Codification of best practices to ensure reliable capture and transmission of transaction data
Datadisaggregation
• Efficient and timelydisaggregation of linked-pedigree serialized data to keep pace with operations
• Standardization of receiving & sales processes to enable data disaggregation process
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Key Tasks for Implementation
Further specification of DSCSA requirements is key to implementation success
Specify hardware capability and compatibility with existing equipment
Ensure robust & secure serialization database in place
Introduce unified TI/TH/TS data exchange process to ensure reliability
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APPENDIX
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