Meeting Current and Future Serialisation Challenges: An AESICA White Paper

Summary:

Serialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another. Several countries including China, South Korea, Turkey, Argentina and Brazil already have regulations in place that must be complied with, whilst many others, including countries in the EU, face pending requirements.

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 EU, require randomized serial numbers. Countries, like China, require their government or local agencies to issue strings of numbers for each batch to the product owner. Some other countries have no requirements on randomization or pre-assigned numbers. 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 complex.

Overview:

Aesica, which has long established expertise in the commercial production & packaging of pharmaceutical products at its Pianezza, Italy, Monheim, Germany and Queenborough, UK sites, has developed the answer. The company has taken the initiative to devise a modular solution that has the benefit of being the same for all countries, whilst enabling customers to meet specific serialisation regulations that vary markedly in different countries across the globe. The highly flexible system achieves this through its capability to maintain data in multiple formats bespoke to each country’s individual regulatory requirements. Consequently, customers benefit from the assurance that Aesica can manage all their serialisation data locally. The company is currently applying its solution to enable customers to meet the specific serialisation demands of China and South Korea. The implementation of serialisation services for the Chinese market, which is one of the most complex, took under six months for Aesica to complete

The company’s serialisation module is also already on hand for customers that need to satisfy the demands of Brazil, the especially complex serialisation regulations of Turkey and Argentina and the less stringent requirements faced by EU countries. A key benefit of Aesica’s solution is the flexibility and the speed with which it can respond to changing customer needs. After discussing and analyzing the precise customer requirement, Aesica can respond by carrying out and initiating its serialisation services in very rapid time.

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