Over 40 countries are today working on track and trace laws and regulations to help secure pharmaceutical products supply around the world. These mandates will have differing scopes, codification formats, and requirements for event reporting and information exchange, resulting in a wide variety of factors to consider and scenarios to manage. Like most serialization mandates, The Drug Supply Chain Security Act (DSCSA), includes many changes and some of them are highly complex in nature. Pharmaceutical companies, and the rest of the life sciences industries like medical device, bio-tech, & bio pharm take measures to meet the new Drug Quality Security Act (DQSA) regulations by November 2017 or to reduce drug counterfeiting and product diversion, they are faced with the challenge of implementing serialization and tracking systems for both self-interest and regulatory compliance. Serialization full suit provides serialization, track & trace, and ePedigree hardware / software solutions, turnkey integration to define and execute on a serialization strategy that covers the factory floor and packaging lines through the entire enterprise and supply chain. Serialization full suit architecture ideally has to be completely open to different corporate ERPs and to the supply chain. It should be completely modular and scalable, and based on a set of cycles with redundant control check of the inbound codes, print the data, and check the outbound codes. The control cycle is carried out by machinery specifically designed for the different levels of the production and packaging line, starting from the single package, to the bundle, the case and finally the pallet. Thus all requirements of production lines with optional checkweighing, labeling and tamper evident seal are met. Integration of full RFID serialization and aggregation technologies is made possible in serialization full suits. Solutions spanning from automatic aggregation to semi-automatic machines as well as manual machines are provided by the global serialization software suit providers depending on line configuration and production requirements.
Standalone Serialization & Aggregation suit may include Carton Serialization, Bottle Serialization, Offline Label Serialization, Case and Palletizing Aggregation, Components for Integration.
After incorporation of serialization compliance regulations, several countries setting new regulations for traceability of prescription drug and biologic products. Majority of the countries are adopting the GS1 Standards (www.gs1us.org) in their serialization process.
Undoubtedly, serialization has many advantages benefiting both end users and pharmaceutical manufacturers. Serialization enables a drug to be tracked and traced electronically as it passes through the supply chain. This means that at any point, authorities and pharmaceutical companies are able to identify and stop the distribution of counterfeited drugs, contain and track the source of contaminated drugs back to its source, handle product recalls more efficiently and effectively
Some pharmaceutical companies have already started implementing the serialization process. One of the biggest challenges is implementing a serialization solution with data that can be easily harmonized with existing operations management solutions
Serialization Suite Key Features include ability to easily create templates such as aggregation at each parent in the packaging hierarchy, serialization at each level without aggregation, serialization at a specific level, specific modules for rework and printing, easy Integration with ERP, MES and quality applications, out-of-the-box integration with native MES applications, localization capabilities, analytics and reports.
Serialization solutions at packaging, pharmaceutical companies can manage multiple serial number formats and aggregate serial numbers across all packaging levels, including unit, bundle, carton and pallet, control all required vision and printing jobs centrally, integrate with existing line control systems or add on to lines with current hardware in place, sync with multiple business systems to share data, including ERP and EPCIS.
Serialization solutions help execute transactions and capture the associated data for Manufacturing, Packaging, Receiving, Pick, Pack, Ship, Rework and Labeling, and seamlessly integrate transaction and serialization information with ERP, EPCIS and other systems across the enterprise.
As a result products from packaging line through distribution can be traced in order to ensure compliance with the DSCSA, GS1 standards and future mandates, gain the real-time traceability you need to effectively manage returns and product recalls, increase customer satisfaction and operational efficiencies with improved order accuracy, extend the capabilities of your ERP systems by providing the granular functionality that’s missing in packaging, warehousing and supply chain modules, protect your brand through the ability to detect counterfeiting and product diversion.