Key Takeaways
- Understand the different serialization requirements for exporting pharmaceuticals to various countries.
- Implement flexible pharmaceutical serialization solutions to ensure compliance with global serialization standards.
- Learn how proper configuration of your pharma track and trace system can streamline export processes.
- Aggregation is essential for maintaining parent-child relationships in pharmaceutical packaging; plan accordingly for each export market.
- Utilize our eTrack L3 application for efficient management of serialization data across multiple packaging lines.
Exporting medicines to multiple countries brings different serialization requirements. From GS1 Data Matrix printing to electronic data reporting, every market has specific expectations. Our pharmaceutical serialization solutions help manufacturers manage these requirements through connected packaging operations.
Proper pharmaceutical packaging line serialization allows manufacturers to prepare for different export markets without repeatedly changing their entire production setup.
Which Country Serialization Rules Should Your Packaging Line Support?
Pharmaceutical regulations vary across international markets. Manufacturers must identify the rules applicable to each destination before configuring serialization equipment.
In the United States, pharmaceutical companies must comply with the Drug Supply Chain Security Act (DSCSA), whereas European markets are governed by the EU Falsified Medicines Directive (FMD) for relevant medicinal products. The UAE uses the Tatmeen pharmaceutical traceability system.
| Export Market | Key Serialization Focus |
|---|---|
| United States | DSCSA package-level electronic traceability |
| European Union | Unique identifiers and anti-tampering safety features |
| UAE | GS1 serialization and Tatmeen traceability reporting |
Our online and offline Track & Trace systems support pharmaceutical packaging operations serving different markets.
Choosing adaptable pharmaceutical serialization solutions helps manufacturers address changing market requirements while supporting global serialization compliance.
How Should You Configure Product Codes for Different Markets?
Different markets may require specific product identifiers, serial-number formats and electronic reporting arrangements.
Our Track & Trace systems are equipped with dual-side code printing capabilities and OCR/OCV technology to verify the accuracy and readability of human-readable information.
A properly configured pharma track and trace system should manage:
- GTIN and applicable product identifiers
- Unique serial numbers
- Batch and expiry information
- GS1 Data Matrix printing and inspection
- Rejection of incorrectly coded cartons
Accurate pharmaceutical packaging line serialization starts with correct product master data and reliable code verification.
Can One Packaging Line Handle Multiple Export Destinations?
Manufacturers typically use the same facility to produce drugs both domestically and internationally. Export changes may necessitate alterations in the data, artwork, and report configurations used in the serialization process.
Our web-based or non-web-based Track & Trace services offer a number of different modes of operation depending on packaging line needs. Non-web-based services are capable of storing serialization data locally until a suitable time to exchange it.
Flexible track and trace services for pharmaceuticals allow manufacturers to operate in different manufacturing environments without tying the serialization process to a particular mode of operation.
For pharmaceutical packaging line serialization, it is advisable that the manufacturer test each configuration in the market.
Why Should Aggregation Be Part of Your Planning?
Serialization identifies individual pharmaceutical packs, while aggregation records their relationship with larger packaging units.
Our Manual Aggregation and Multi 2D Aggregation solutions support parent-child relationships between serialized packs, cases and pallets.
When selecting serialization and aggregation software, manufacturers should consider:
- Individual pack serialization and verification.
- Case-level aggregation and identification.
- Parent-child relationship recording.
- Pallet-level aggregation where applicable.
- Data reconciliation before shipment.
Aggregation requirements differ between markets, so the required packaging hierarchy must be confirmed for each destination.
Sun Teknovation Pvt Ltd. provides aggregation systems that can work alongside pharmaceutical serialization operations.
How Can Multiple Packaging Lines Share Serialization Data?
Handling multiple packaging lines can pose some difficulties in keeping proper records of serial numbers and production details.
Our eTrack L3 application is plant level software that helps in managing the processes of serialization and aggregation.
An effective serialization and aggregation software solution should enable seamless coordination of production-line operations while ensuring efficient management of serialization data in accordance with applicable requirements.
In selecting a pharmaceutical track and trace system, manufacturers must look at the exchange of information between packaging machines and plant level software.
What Should QA Verify Before Export Production?
Before releasing serialized pharmaceutical batches, packaging and quality teams should test the configured process.
Our systems support OCR/OCV verification, Data Matrix inspection and automated rejection functions for incorrect packs.
Sun Teknovation Pvt Ltd. provides line-level serialization technologies that can support the following checks:
- Correct product identifier and serial-number format.
- Accurate batch and expiry information.
- Readable GS1 Data Matrix codes.
- Reliable rejection of incorrect cartons.
- Correct aggregation relationships where required.
- Serialization records available for reconciliation.
These checks support global serialization compliance, while suitable serialization and aggregation software helps maintain organized packaging data.
What Steps Can You Take to Stay Prepared for Evolving Regulatory Requirements?
However, regulatory expectations may vary depending on whether or not the countries in question adopt new track-and-trace platforms or report differently. Companies should opt for systems that are flexible enough to handle any coding format changes, packaging and data exchange process changes.
Our online and offline Track & Trace solutions are developed to meet the diverse needs of manufacturing environments. Additionally, eTrack L3 provides centralized monitoring and streamlined management of serialization activities, ensuring smooth coordination and operational efficiency across plant-level processes.
A flexible serialization system for pharmaceuticals can ease the burden of meeting new demands of the market. Regular configuration audits will be useful to help companies meet global serialization standards as export requirements evolve.
Why Choose Us
Sun Teknovation Pvt Ltd. assists pharmaceutical companies in providing online and offline Track & Trace solutions, Manual and Multi 2D Aggregation, DataMatrix inspection and eTrack L3 plant level software. The solutions provided by us have been formulated to cater to various packaging lines and export needs. We help in connecting line level identification with serialization and aggregation software.
Conclusion
The preparation of a packaging line to produce pharmaceuticals in different countries will need proper identification, coding inspection, aggregation planning, and handling of electronic data. It is necessary that the manufacturer should look into the needs of the country to which the product is being exported before setting up their production facilities.
An appropriate pharmaceutical tracking and tracing system will be able to integrate the packaging line with the process of serialization and the following electronic data handling process. Our knowledge of pharmaceutical packaging line serialization will make this task easier for you.
Planning to upgrade your packaging line for multiple international markets?
Sun Teknovation Pvt Ltd. offers serialization, aggregation and Track & Trace solutions for pharmaceutical manufacturers.
Contact our team today to discuss your packaging-line requirements and request a solution consultation.
Call: +91 98982 45695 or Email: connect@sunteknovation.com.
Frequently Asked Questions
Pharma Serialization Global Pharma Compliance Pharmaceutical Track and Trace GS1 Data Matrix Pharma Packaging Automation Serialization Software Pharmaceutical Aggregation Multi-Country Serialization Pharma Export Compliance eTrack L3
