Track and Trace Compliance Requirements

 

Regulatory Agencies Requirements for Track and Trace
 

Product Uniqueness

A unique serial number is associated with each level of product packaging. The Optel Vision TrackSafe™ offers support for both printed serialized codes or RFID tags in order to encode the electronic product code. The Optel Vision solution integrates the proper optical and/or RFID devices to verify any encoded serial number along the packaging line. The system stores all relevant information within the product traceability database and/or ePedigree.

 

Aggregation

Most serialization regulations require the capturing of the parent-child relationship from the sales unit to the pallet. When a pallet leaves the packaging line, the serialization data must contain the information allowing it to know which item is in which secondary pack, shipper and/or pallet.

Aggregation is the action of identifying all items in a package in order to register the parent-children relationship information. Accurate aggregation registering is the key for smooth and efficient serialization solution integration. The Optel Vision TrackSafe™ uses a proven vision system and RFID technology for accurate and reliable item aggregation registration.

 

Worldwide Regulations for Track and Trace

Due to possible changes in regulations, the following information should be verified directly with the specific regulatory agencies.

 

Country Track and Trace Requirements for Pharmaceutical Manufacturer Target Date

USA - FDA (DQSA)

Traceability requirements (TI/TH/TS) starting Jan. 1, 2015
Year 4 - Serialization/product identifiers
Year 10 - Complete unit level tracing
2017
Turkey SGTIN with batch number and expiration date at item level
Future plan to require aggregated serialization data
In effect
Europe FMD
Security feature to be announced early 2014.  Expected to be point of dispense verification system with item level serialisation (SGTIN; carrier 2D; GS1 standards) and tamper evident labeling.
2017
France All products registered  at CIP
CIP code + batch number in a ECC200 Datamatrix at item level
Future plan to follow EFPIA
In effect
Canada GTIN with Lot & Expiry at item level, structure will be ready for SGTIN Under discussion
Brazil Serialized 2D datamatrix codes printed directly at the unit level 2015
China

List of the products that must be serialized and aggregated (Chinese)

English Version

China NDC+ serial number on primary and secondary packages up to the pallet with hierarchy information. For the moment, applies for drugs listed in the National Essential Drug List (NEDL). Other products expected for 2013. May 2011
India

Primary Level packaging requirement  (Blister Packing System - on coding on blister strips or strip packing machine and Labeling on Bottle - for bottle line)

Incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding unique product identification code (GTIN) and Unique Serial Number of the Primary pack.

Secondary Level packaging requirement  (Auto / Semi Cartonator - for Blister and Strip Line or Manual Packing - Mono Carton - Outer Carton, etc)

Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Secondary pack.

Tertiary Level packaging requirement  (Carton / Bundle to be packed in Case)

Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton).

July 2014

 

 

January 2014

 

 

 

October 2011

 

 

Korea Incorporation with unique Serial Number and Expiry Date for Special/Professional Drug (including selected drugs) 2015