Serialisation regulations: the scale of the challenge

Published: 9-Nov-2016

Meeting existing and future challenges in the market

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Serialisation has emerged as a seriously complex challenge for today’s pharmaceutical industry. The sector is now faced with a multiplicity of differing regulations governing serialisation that vary country by country.

Several countries including China, Turkey, South Korea, Brazil and Argentina already have different types of regulations in place, all of which must be complied with and require different types of serialisation solutions for their pharmaceuticals. Many others, including countries in the European Union (EU) and the United States, face pending compliance requirements.

In all countries, including China, the unique information required for packaging needs to be printed both in human readable form and with either a 2D matrix barcode or a linear bar. Some country specific serialisation regulations, such as those in the EU, require randomised serial numbers.

In the case of countries such as China, their government or local agencies are required to issue strings of numbers for each batch to the product owner. Equally, some other countries have no requirements on randomisation or preassigned numbers. Add to this the requirements for laser print or ink printing techniques and for tamper evidence, including security labels, anticounterfeiting ‘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 minimising financial loss.

As a consequence, specialist technical knowledge is now an essential prerequisite to support the needs of customers in the serialisation field. This includes being familiar with the critical interfaces between the various scientific and functional aspects, and knowledge regarding 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 minimised risk. This knowledge has been put to effective use to develop the very solutions that the pharma sector, faced with these complex and varying serialisation challenges, needs to initiate.

Industry solutions are at hand

Technological solutions have been developed that tackle this critical serialisation challenge head on — enabling full compliance with all the various, differing serialisation requirements. Flexible and fast single platforms that enable regulatory compliance across multiple geographies have been developed, are fully functional and available to the market right now.

These serialisation modules are at hand for integration into production lines. One of the key benefits of these technological solutions is flexibility and the speed with which they can respond to changing customer needs. After discussing and analysing the precise customer requirement, the CDMO can respond by initiating and implementing its serialisation services in a very short period of time. The modules are capable of high resolution printing at fast line speeds, with advanced communication protocols for remote operation and high speed serialisation.

CDMOs such as Aesica, 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 advantage of being the same for all countries, whilst enabling customers to meet specific serialisation 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 that are bespoke to each country’s individual regulatory requirements. Consequently, customers benefit from the assurance that their CDMO can effectively manage all their serialisation data locally.

Such technology can, for example, enable the implementation of serialisation services for countries such as South Korea and China, which has one of the world’s most complex set of requirements. Aesica’s module, for example, has enabled compliance with China’s stringent regulations to be met in full in a project that took as little as 6 months to implement and complete.

Furthermore, such modular technology is already on hand for customers that need to satisfy the demands of Brazil, the particularly complex serialisation regulations of Argentina and Turkey, as well as the less stringent requirements faced by countries in the EU.

During the output phase of serialisation, 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, such as China. Both the input and output of the data generated for serialisation and the aggregation is completely customised.

Meeting the serialisation needs of China

To meet the serialisation needs of the Chinese market, pharmaceutical companies are required to be fully compliant with the guidelines of the Ministry of Health of China, specifically regulation SFDA No. 64 (2012). Since January 2014, modular technology has enabled pharma companies to successfully identify and put into use adequate solutions, processes and the hardware and software necessary to render saleable units tamper evident, serialise 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.

High level flexibility

It is also critically important that packaging lines are flexible enough to support multiple serialisation and coding requirements. No matter what system the customers are using, CDMOs must provide the capability to receive the information, including purchase orders and preassigned serial codes, and to upload the data into their ERP application. Advanced technology and efficient approaches enable CDMOs to identify each individual packaging unit right down to the smallest saleable unit concerned.

Provision of full logistical flow

Advanced technical approaches are also bringing a further 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 individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets.

Plant management

The inability to provide plant management services to customers in the serialisation 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 available 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. To best ensure that the highest standard of compliance is achieved, pharmaceutical companies are actively on the lookout for proven world-class platforms to print 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 crucially important — including the ability to print one-dimensional barcodes (linear, GS1 128, UPC), alternate fonts, logos and two-dimensional codes (GS1 Data Matrix and Quick Response QR).

The technology concerned must be easy to integrate into production lines; and, crucially, it must be designed for high resolution printing at fast line speeds. Moreover, advanced communication protocols for remote operation and high speed serialisation, 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 vital area.


In today’s competitive landscape, the complex web of serialisation regulations, which differ from one country to the next, has posed a major challenge to the pharmaceuticals sector. To meet the challenge, 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 that they are faced with. The rapidity and proven reliability of this technology has made it a great asset that is now readily available to the global pharmaceutical industry.

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