Capitalising on coding innovation in the pharmaceutical industry
Tim Kearns, Strategic Account Manager US - Pharmaceutical Market, Videojet Technologies, examines how manufacturers can comply with legislation while maximising productivity
The pharmaceutical industry worldwide has enjoyed steady growth in the past five years, despite the global economic downturn. However, a number of strict regulations are about to come into force over the next few years requiring pharmaceutical manufacturers to take steps to minimise the threat to consumer safety posed by counterfeit drugs.
What are the latest developments in the legal landscape for the pharma industry?
In November 2013, the US signed into law the Drug Quality and Security Act (HR 3204). Title II of this law, the Drug Supply Chain Security Act (DSCSA), addresses the security of the pharmaceutical supply chain by outlining a track and trace system to minimise opportunities for contamination, adulteration, diversion or counterfeiting. The act has set a deadline of 2017 for drug manufacturers to upgrade their production lines to enable them to print unique serial numbers on their product packaging, and 2023 to introduce electronic coding capable of tracking medicines from the factory to the pharmacy shelf.
In the global pharmaceutical industry, labelling and coding continues to be a critical area and the topic of what constitutes appropriate identification is open to interpretation in a number of markets. What is absolutely clear is that the trend worldwide indicates that traceability will become a requirement for pharmaceutical manufacturers over the coming years. As such, manufacturers must start looking at their production lines to determine how to deploy a new or existing track and trace system compliant with the legislation in their target markets. The time of the wait and see attitude is long past; urgent action is now required.
How can coding technology help pharma manufacturers ensure regulatory compliance without affecting productivity?
Precision in labelling and coding is a must in the pharmaceutical industry, especially for businesses exporting into markets where supply chain traceability is a legal requirement.
In a complex regulatory environment, there is no room for error.
New serialisation-ready printers can help ensure the necessary variable data, like serial number, lot and expiry date, is transmitted smoothly and results in high quality coding for regulatory and supply chain requirements. The latest generation of coding printers has a track record of successful integration into even the most challenging pharmaceutical production lines and OEM equipment, allowing code assurance without compromising productivity.
Errors caused by entering the wrong code are always at the forefront of a manufacturer’s mind as they can lead to product rework or brand-damage
There are a number of coding technologies that manufacturers can utilise, from thermal ink jet and continuous ink jet printing, to thermal transfer overprinting and laser marking. These printers are designed to offer precise, quality codes at high speeds on a wide variety of substrates. These technologies are ideally suited for printing codes accurately on pharmaceutical products’ primary, secondary and tertiary packaging for clear identification as they move through the supply chain.
Errors caused by entering the wrong code are always at the forefront of a manufacturer’s mind as they can lead to product rework or brand-damage. Even in instances where final labelling is completed post-autoclave, on-vial traceability codes ensure the integrity of the data through the packaging process. In collaboration with a solution provider, manufacturers can create and implement a coding procedure with built-in code assurance elements designed to limit the potential for user error. Simplifying the process of message selection and entry through the use of automation and software tools can prevent coding errors, increase productivity, reduce waste and minimise operational costs and risk.
What is the future for coding technology?
Precision labeling and coding will continue to develop in conjunction with innovations in pharmaceutical packaging, particularly for new materials and coatings such as flexible packaging materials and DataLase. For example, there has been considerable growth in blow fill seal (BFS) bottles, snap-off ampoules, vials, and prefilled syringes, and the advances in printing technologies have allowed for proper coding of these types of packaging.
Over the coming years, we can expect more governments in key global markets to introduce stringent traceability regulations for pharmaceutical products to tackle the pressing issue of drug counterfeiting and patient safety. In a number of jurisdictions, such as the European Union (EU), we are already anticipating legislation requiring the serialisation of individual cartons to be fully implemented by 2018.
It is important for manufacturers to find the right solution rather than simply picking the right printer
To help manufacturers meet these increasingly rigorous standards, coding technology has developed well beyond just a printer to include methods of ensuring the right code is on the right place at the right time. In addition, future ink developments will ensure that printers become even more versatile in printing onto a wider range of substrates and also respond to increased environmental awareness.
It is important for manufacturers to find the right solution rather than simply picking the right printer. Manufacturers should note that not all inks, ribbons and other supplies are created equal for any particular coding technology. Specific application needs, such as smudge resistance or high-resolution bar codes or even packaging film type can affect ink or ribbon selection. Environmental conditions can also dictate which ink or ribbon is best for the application. Understanding these factors, experienced suppliers can offer an advanced portfolio of supplies for each technology and their expertise can help manufacturers get the most from their printer.
In summary
The pharmaceutical industry is only going to grow more competitive as manufacturers continue to increase their efforts in emerging global markets. Supply chains will become more complex as companies are required to meet the multiple facets of safety legislation.
It is vital, therefore, that manufacturers carefully consider the quality and overall equipment effectiveness (OEE) of their production line processes. Their coding technology in particular, will make certain they are capable of complying with even the most stringent regulations while enhancing productivity and allowing flexibility for future.
Author
Tim Kearns is a Strategic Account Manager at Videojet Technologies, responsible for key accounts in the pharmaceutical and medical industries in North America.
