Prevention is better than a coding cure

Although existing methods of detecting coding errors are a safeguard against potential problems, why are companies tolerating errors in the first place? James Butcher suggests companies need to take a more active role in their prevention

Accuracy in pharmaceutical package coding is essential: the tolerance for error is zero. Consumer safety is a primary consideration for all manufacturers, but in the pharmaceutical industry, where permanent harm or death can result, it is vital. In the US in past years, coding or labelling errors were the cause of at least 50% of product recalls, at a typical cost of between £1m and £30m each time, never mind the loss of reputation, customers and sales.

Accurate product coding is a legal and commercial necessity, and one that requires a precise monitoring process to ensure erroneous coding data reaches neither customer nor consumer. Traditionally, automatic inspection, such as online character recognition (OCR) or verification (OCV), has been used to detect and therefore reduce package and product coding errors in the pharmaceutical industry.

Yet as the risks and costs associated with errors continue to rise, it is becoming increasingly necessary and more cost effective to develop an approach that emphasises prevention rather than cure.

human error

The problems of package coding errors are not lessened by progress in technology. Over the last 15 years electro-mechanical coders have been replaced with digital coding equipment; more than 90% of all on-line coding is now completed using digital equipment. Yet the majority of package coding equipment is still set up manually by operators, and this is where most of the problems arise. Even the most experienced, attentive operator can still make mistakes. Human error accounts for the majority of coding errors, necessitating expensive on-line verification and, should the monitoring process reveal errors, the even more expensive reworking of product. Ironically the majority of verification equipment is also set-up manually and therefore while consistency throughout a product run can be controlled, the scope for human error is not eliminated.

The solution is to take manual set-up out of the equation. Package coding management systems, by providing automatic set-up of coding and labelling equipment, are a proven and efficient method of eliminating coding errors at source and at less than 20% of the cost of alternative vision systems and on-line inspection. In essence, package coding management systems remove the need for manual input on a day-to-day basis by using an automated rule-based approach. Once the validity and accuracy of all variable coding data has been approved, it can be transmitted across the network, meaning data need no longer be keyed in separately on each machine.

In a proven system such as Claricom's CLARiNET, a programmatic generic coder interface (GCI) will allow industry standard integration with manufacturing execution systems (MES) and other enterprise IT systems to form an essential part of a 21 CFR Part 11 compliant solution, removing the need to store or set up essential product coding information within the package coding equipment on each line.

A key advantage of package coding management systems is their compatibility with all major makes of coding equipment. Most manufacturers use a variety of coding and labelling equipment to address the requirements of different packaging types and configurations.

For example, low resolution or dot matrix coding technologies, such as continuous ink jet, have become the most prevalent method of primary package coding, despite the fact that the technology of vision systems for these is still largely unproven or inappropriate.

FDA approval

The flexibility of package coding systems provides the freedom to choose the most appropriate coding equipment for an application, without compromising on-line performance.

Claricom CLARiNET, for example, is proven in FDA-validated medical and clinical trial applications and is designed to work with all major coding technologies and equipment manufacturers.

By eliminating the traditional problem of integrating coding equipment from different manufacturers, package coding management systems can therefore provide an effective network-wide method of immunising against errors.

When product manufacture depends increasingly on meeting strict regulations and FDA approval for packaging and labelling, a principle of prevention rather than containment can go a long way to ensuring healthier production lines.