Serialisation regulations: the scale of the challenge

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.