Effective Printing for US Pharmaceutical Compliance
- Richard Nemesi, Global Vertical Manager, Pharmaceutical and Medical Devices, Videojet

Virtually no industry is safe from the threat of potential financial and brand value losses caused by supply chain errors. But few face consequences as substantial as the pharmaceutical industry. Ensuring the right medication or device goes into the right hands, in the right location, at the right time is critical to pharmaceutical manufacturers, their supply chain, and ultimately the health and well-being of the end consumer.

Developing systems and adhering to best practices designed to mitigate production risks would be a tremendous industry challenge under any circumstances, but it's especially challenging when worldwide pharmaceutical industry growth and product demand are on the rise. In 2014, the IMS Health projected that the global pharmaceutical market will increase to between USD 1.135 trillion and USD 1.235 trillion by 20171, forecasting as much as a three percent rise per year.

Global Trends on Pharmaceutical Market
Since the introduction of the bar code over 60 years ago, the need for manufacturers to better convey supply chain history through effective printing has increasingly become critical industry component. At its most basic, product codes hold data on lot/batch number, timestamps, expiration dates and packaging types. But over the past 20 years, those needs have expanded, to include information such as Global Trade Identification Numbers (GTINs) and unique serial numbers.

Government and pharmaceutical industry perception and implementation of coding have changed as well. Historically, coding was primarily instituted as a crisis management tool - something used to identify drugs that needed to be pulled off shelves. Now coding and marking are now actively being implemented as an offensedriven, strategic oversight method, using unique product serialization numbers as fail safes to confirm the identity of products at multiple points of production and distribution.

Meanwhile widely publicized reports of worldwide counterfeit and/or mislabeled pharmaceuticals have heightened the charge for stronger preventative action. Governmental pressures on pharmaceutical manufacturers, to improve supply chain track-and-trace capabilities through the delivery of serialized printed information, on primary, secondary and outer case packaging, have increased. Manufacturing, packing and shipping more medications, medical machinery and medical devices vastly increases potential for human and mechanical errors- as well as opportunities for counterfeits and security breaches to enter the supply chain. Finding printing solutions to respond to these challenges have become a key priority for manufacturers and medical device companies.

Main Changes on Pharmaceutical Market in US and its Effect on Packaging
Manufacturers and Drug Producers On January 1, 2015 the initial phase of the US Food and Drug Administration's(FDA) 2013 Drug Supply Chain Security Act (DSCSA) will take effect across the US. DSCSA mandates the development of a national unique product serialization system to track all pharmaceutical products at every stage along the supply chain. Over the next eight years, drug manufacturers, wholesale drug distributors, repackaging companies and pharmacies will be expected to cooperate with US Food Drug Administration's (FDA) efforts to develop, test and implement through a phased approach.

For medical devices, the FDA finalized its specifications for Unique Device Identification (UDI) in September of 2013, with a phased implementation of coding requirements based on device class through 2018.

The scope and impact of the DSCSA and UDI regulation will require major packaging changes from all pharmaceutical manufacturers. Companies must develop the capability to print unique serial numbers on prescription drug packaging and unique device identifiers for medical devices. This process often requires investments up and down the production line and integration with enterprise resource planning (ERP) systems.

But among all of the production, operations and technology challenges truly lives one main core essential purpose: the delivery of information held in product coding and labeling. The FDA's impending serialization requires more information to live inside each product's code to be effectively track products throughout the supply chain. Traditional linear bar coding revised in 2007 is not designed to hold this breadth of information efficiently, which means that many pharmaceutical manufacturers are now undergoing efforts to switch to two-dimensional (2D) bar codes.

How these Changes Relate to International Coding Standards?
Many companies are using GS1 guidelines to create codes. To meet the requirement for Automatic Identification and Data Capture (AIDC), a method of automatically collating data and entering this into tracking systems - information can be conveyed through a 2D coding standard called GS1 DataMatrix or stacked, linear bar code called GS1 DataBar.

As medical device and pharmaceutical manufacturers prepare to comply with FDA regulations, they are evaluating the ability of existing printing systems to deliver the required results.

Meeting these world wide trends demanding advanced coding, serialization and labeling regulations, requires printing technology capable of delivering more information, with no-fail readability, on smaller spaces. Coding and serialization solution providers are poised to provide application solutions designed to deliver the highest quality human and machine readable codes to ensure product traceability and visibility regardless of package type.

A number of printing options are available to meet the multi-packaging and labeling needs of the pharmaceutical and medical device industries. Popular options include, but are not limited to:
  • Thermal InkJet (TIJ) - High-resolution, ink-based, non-contact printing used for coding on flat substrates such as cartons. Even complex codes feature multiple lines of text and 2D DataMatrix codes remain highly readable at rapid line speeds.
  • Laser - Laser printing systems simplify the process and improve the permanency of pharmaceutical codes by marking directly on the material surface without physical contact or need for ink supplies.
  • Thermal Transfer Overprinter (TTO) -A digitally controlled printhead precisely melts ink from a ribbon directly onto flexible films to provide high-resolution, real time prints. Ideal for marking flexible packaging, thermal transfer coders offer high quality codes from date, lot and time stamps to more complex codes such as bar codes.
  • Continuous InkJet (CIJ) - CIJ is the most versatile of all variable coding technologies and can print on nearly any package type or product shape. Fast print speeds and a range of application-specific inks make it ideal for challenging applications.

In addition to the right technology, pharmaceutical companies need to find the right application partner to help them make the most cost-effective, fastest, high quality coding and labeling solutions. A true partner will play an active role in ensuring deployment success and servicing its technology throughout the lifecycle of the printer. Taking the right measures to implement and support best-in-class solutions could mean the difference in fines, recalls, re-work and, potentially, patient safety.

Despite the challenging road ahead in the changing global regulatory landscape, above all else, pharmaceutical companies should know their efforts will be met with great potential gains brought by through increased consumer confidence and brand loyalty. Most importantly, they ensure the right, safe, regulated drugs and medical devices get in the hands of the people who need them.