Regulatory Agencies Requirements for Track and Trace
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.
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.
||Track and Trace Requirements for Pharmaceutical Manufacturer
|USA - California
||For prescription drugs only
SGTIN at item level for prescription products
Aggregated serialization data
||Backing California regulation, working on defining the final system architecture before setting a date for compliance
||SGTIN with batch number and expiration date at item level
Future plan to require aggregated serialization data
||SGTIN at item level
||All products registered at CIP
CIP code + batch number in a ECC200 Datamatrix at item level
Future plan to follow EFPIA
||GTIN with Lot & Expiry at item level, structure will be ready for SGTIN
||Serialized 2D datamatrix codes printed directly onto secondary packaging
List of the products that must be serialized and aggregated (Chinese)
|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.
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).
||South Korea, Serbia and many others are working on regulations which require item level serialization and some aggregated data