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 (without serialization) Target Date (with serialization)
USA - FDA (DQSA) Traceability requirements (TI/TH/TS) starting Jan. 1, 2015

Year 4 - Serialization/product identifiers
Year 10 - Complete unit level tracing
Standard: SG1
S/N type: SGTIN (item  and case levels) ; SSCC (pallet level)
Model and data: FDA to conduct workshop in 2014-2015 to help write regulations
2017 2023
Turkey Future plan to require aggregated serialization data
Standard: GS1
Carrier: 2D barcode

S/N type: SGTIN (item level) ; SSCC (case and pallet levels)
Random: no
Model + data: Track & Trace (central database)
2010 2013
India

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

S/N type: SGTIN
Standard: GS1
Carrier 2D barcode
Random: no

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

S/N type: SGTIN
Standard: GS1
Carrier: 2D barcode
Random: no

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

S/N type: SSCC
Standard: GS1
Carrier: 2D barcode
Random: no

2014

 

 

2013

 

 

 

2011

 

-

 

 

-

 

 

 

2015

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

or

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. Serialization is progressively introduced and will have to be 100% effective in 2015.
Standard: custom system
Carrier: 1D barcode
S/N type: E-code
Random: yes
Model + data: numbers come from the government database. Aggregation must be sent to government. Last 4 digits of E-code is an encrypted checksum which makes it look like random and is used as an authentication feature.
- 2015
South Korea Incorporation with unique Serial Number and Expiry Date for Special/Professional Drug (including selected drugs)
Standard: GS1
Carrier: 2D barcode or RFID
S/N type: SGTIN (item level)
2015 -
Taiwan Standard: GS1
Carrier: 2D barcode
2015 2018
Mexico Standard: GS1
Carrier: 2D barcode
S/N type: SGTIN
2016 2016
Saudi Arabia Standard: GS1
Carrier: 2D barcode
S/N type: SGTIN
Model + data: Serialization only (central database)
2016 -
Brazil Standard: GS1
Carrier: 2D barcode
Random: yes
Model + data: Track & Trace (central database). 3 batches must be done by 2015-12-10. All products must be serialized by 2016-12-10
2016 2016
Europe FMD Standard: possibly GS1
Carrier: 2D barcode
Random: yes
Model + data: Serialization only (central database). Countries in the EU have until 2015 to vote their local law
2017 -