Background to Today’s Serialization Challenge
Serialization has emerged as a complex challenge for the pharmaceuticals sector. The industry is currently facing a multiplicity of differing regulations governing serialization that vary from one country to another. Several countries including China, South Korea, Turkey, Argentina and Brazil already have different types of regulations in place, that must be complied with, that in turn require different types of serialization solutions for their pharmaceuticals, whilst many others, including countries in the EU and the US, face pending compliance requirements.
In general all regulations, with the notable exception of those governing China, demand a datamatrix code complete with the content expiry date, batch number, GTIN and serial number. Moreover, in the case of Brazil, there is an alternative demand for the ANVISA local registration number. To make matters even more complex, Germany also has its own alternative to GTIN - the local NTIN code.
In all countries, the unique information required for packaging needs to be printed both in human readable form and with either a 2D matrix bar code or a linear bar code - as is the case with China. Some countries, such as the EU, require randomized serial numbers. Certain countries, like China, require their government or local agencies to issue strings of numbers for each batch to the product owner. Equally, some other countries have no requirements on randomization or pre-assigned numbers. Add to this the requirements for laser print or ink printing techniques and for tamper evidence, including security labels, anti-counterfeiting “self-destructive” carton boxes or glued carton boxes, and the situation becomes highly complex. The main goal of all these new requirements is to maintain customer safety whilst fighting drug counterfeiting, streamlining the recall process and minimizing financial loss.
Consequently, specialist technical knowledge is now an essential pre-requisite for supporting the needs of customers in the field of serialization. This includes possessing familiarity with the critical interfaces between the various scientific and functional aspects and possessing the knowledge on how best to balance them to reach the optimal solution, accommodating relevant regulatory requirements and advanced market technology demands. Ultimately, this results in increased control, the highest levels of efficiency and minimized risk.
This knowledge has been put to effective use to develop the very solutions that the pharma sector, faced with these complex and varying serialization challenges, needs to initiate.
Industry Solutions
Industry solutions have been developed which tackle this critical serialization challenge head on - enabling full compliance with all the various serialization requirements. Flexible and fast single platforms that enable regulatory compliance across multiple geographies have been developed, are fully functional and are available to the market as of now.
These serialization modules are available for integration into production lines. A key benefit of these technological solutions is flexibility and the speed with which they can respond to changing customer needs. After discussing and analyzing the precise customer requirement, the CDMO can respond by carrying out and initiating its serialization services in very rapid time. The modules are capable of high resolution printing at fast line speeds, with advanced communication protocols for remote operation and high-speed serialization.
CDMOs which have long established expertise in the commercial production and packaging of pharmaceutical products, have put their expertise to effective use by devising modular solutions that bring to the table the industry benefit of being the same for all countries, whilst enabling customers to meet specific serialization regulations that vary markedly in different countries across the globe. These highly flexible systems achieve this through their capability to maintain data in multiple formats bespoke to each country’s individual regulatory requirements. Consequently, customers benefit from the assurance that their CDMO can effectively manage all their serialization data locally.
Such technology can, for example, enable the implementation of serialization services for countries such as South Korea and China, which has one of the world’s most complex set of requirements. One such module, for example, has enabled full compliance with China’s stringent regulations to be met in full in a project that took as little as six months to implement and complete. Furthermore, such modular technology is already on hand for customers that need to satisfy the demands of Brazil, the especially complex serialization regulations of Turkey and Argentina, as well as the less stringent requirements faced by countries in the EU.
During the output phase of serialization, the advanced modular solutions also have the technical advantage of being able to create whatever files are required by the customer - including satisfying demand for a format that suits a specific country, for example, China. Both the input and output of the data generated for serialization and the aggregation is completely customized.
Using the Modular Technology to Meet the Serialization Needs of China
In order to meet the serialization needs of the Chinese market, pharma companies are required to be compliant with the guidelines of the Ministry of Health of China, specifically regulation SFDA No. 64, 2012. From January 2014, modular solutions exist that can enable pharma companies to successfully identify and put into use adequate solutions, processes and the hardware and software necessary to render saleable units tamper evident, serialize saleable units and to establish the relationship between shipper cartons and saleable units contained within it, putting in place a full traceability process, from production right through to the final end user.
To achieve best results, it is highly important that CDMOs are familiar with the critical interfaces between the various scientific and functional aspects and that they possess the knowledge to balance them to reach the optimal solution – one that accommodates relevant regulatory requirements and market technology demands in full. Ultimately, this results in increased control, high efficiency and minimized risk.
Level of Flexibility
It is also highly important that packaging lines are flexible enough to support multiple serialization and coding requirements. No matter what system the customers are using, CDMOs must provide the capability to receive the information, including purchase orders and pre-assigned serial codes, and to upload the data into their ERP application. Efficient approaches and advanced technology enable CDMOs to identify each individual packaging unit right down to the smallest saleable unit concerned.
Full Logistical Flow
Advanced technical approaches are also bringing a further strong advantage to the market – namely the provision of full logistical flow and aggregation support. This provides customers with the capability to seamlessly track and trace every single package of medication. There are modular solutions available that support all levels of aggregation including units, shippers and pallets.
Technological innovation can aggregate indi-vidual unit serial numbers as packages are bundled, boxed and placed on shipping pallets
Plant Management – A Further Critical Industry Challenge
The inability to provide plant management services to customers in the serialization process has been a further industry challenge that the CDMO sector has needed to tackle head on. Plant management essentially covers everything from hierarchy, serial numbers, data storage and protocols.
Modular solutions are in places that provide full visibility over the entire production flow – including plant management. In particular, this entails a full four level solution. These four levels comprise the following: components at the line, line management and administration, plant management and customer interface.
Such solutions ensure the smooth running and provision of real-time verification and printing, the provision of batch and serial numbers to the lines, and the sending back of used and rejected serial numbers,
Critical Features for the Modular Technology
To best ensure that the highest standard of compliance is met, pharma companies are actively on the lookout for proven world-class platforms for printing variable data including, for example, human readable and 2D and linear barcodes.
The highest quality of variable coding is critical with the need for clear and easy to read alphanumeric characters. The capability to enable more complex coding options is also crucial - including the ability to print 1-dimensional bar codes (linear: GS1 128, UPC), alternate fonts, logos, and 2-dimensional codes (GS1 Data Matrix and Quick Response QR), The technology must be easy to integrate into production lines, and crucially must be designed for high resolution printing at fast line speeds. Furthermore, advanced communication protocols for remote operation and high speed serialization, easy to use technology with simple operations that enable users to focus on production and not printers, and inks that are suitable for a wide variety of applications, are also highly important in meeting the industry’s complex set of needs in this area.
Conclusion
The complex web of serialization regulations, differing country by country, has posed a major challenge to the pharmaceuticals sector. Forward looking CDMOs have developed modular solutions that provide flexible, fast and highly advanced single source platforms that enable customers to comply with multiple/any given set of country specific regulations. The rapidity and proven reliability of this technology has made it a great asset available to pharma across the globe.