Secure to the Max

Most people never think of packaging as a life-or-death proposition, but for companies that handle the intricate and complex business of pharmaceutical packaging, that’s exactly what’s at stake.

With counterfeiting becoming a growing international problem, the integrity of a pharmaceutical brand and the confidence of consumers in that brand depend to a large extent on the security and traceability of data prior to print. The introduction of new drugs requiring more information drives new layouts to support the Food and Drug Administration’s (FDA) labeling requirements for pharmaceutical inserts, brochures, directional circulars, and patient information labeling. This makes compliance a critical element of pharmaceutical package design and places much of the responsibility for drug security squarely on the shoulders of the pharmaceutical converter.

It’s a tall order, with an absolute requirement for quality that incorporates a zero tolerance for error, rework, and extra production costs associated with incorrect bar coding and legal, product-ingredient, or product-use text. The process is made all the more challenging by the need for distributed collaboration among a staggering array of supply-chain partners. These can include graphic and structural designers, trade shops, printers, converters, finishers, die makers, legal and editorial departments, marketing and product development teams, and others that may be called upon to scrutinize and authenticate a project on its way to the press, and then to market.

Federal constraints governing the use and description of drug and biological products add layers of complexity. Intense competition for market share among pharmaceutical manufacturers places a premium on time-to-market and magnifies the pressure on the converter. It is not unusual for converters to work within time frames as narrow as 24 hours between FDA approval and product launch to enable their customers to be “first on the shelf” with a new medication.

This month, packagePRINTING takes a look at some of the special prepress challenges associated with pharmaceutical packaging. To help us sort through some of these concerns, we spoke with Sue Fowler, director of customer service, prepress, and information services for NOSCO, Inc., a supplier of high-quality printed packaging that specializes in product launches for pharmaceutical, medical device, biotech, and other regulated industries.

Clean slate every time

Strict process control begins with basic computer housekeeping. “We start each job with nothing on the desktop except software,” Fowler says. From here, it extends to optimizing the efficiency of the entire supply chain to improve operational margins and reduce costs. “The quicker a customer can bring a product to market, the better,” says Fowler.

However, because pharmaceutical printers prefer to avoid printing “at risk” (i.e., pending FDA approval), “Pharmaceutical packaging usually involves a huge time crunch. NOSCO does a lot of product launches and specializes in fast turnaround, which often means receiving FDA approval on a Friday afternoon and having to proof, plate, print, and deliver a package by Monday morning. Being able to deliver that package even one day early makes a big difference to our customers,” he says.

Now you see it, now you don’t

Counterfeiting and product diversion are the twin plagues of pharmaceutical manufacturing, and a primary driver of advances in pharmaceutical packaging. To protect patients (and legitimate manufacturers themselves) from counterfeit drugs, state and federal laws now require a certified chain of custody, or “pedigree,” for pharmaceuticals covering drug products and devices from the point of manufacture to dispensing. A number of states have already enacted so-called “ePedigree” legislation; others have such legislation pending.

To counter these trends, security features—such as serialization; thermochromic, coin-reactive, color shifting, or invisible ink; optical watermarks; holograms; tamper-evident seals; hard-to-reproduce microprinting; and other overt and covert identification symbols—can be incorporated in packaging to provide authentication and redundancy and to deter counterfeiters. According to Fowler, NOSCO has a sales arm that consults with pharmaceutical customers on the best way to help secure their products.

Speaking in code

FDA regulations also now require pharmaceutical manufacturers to incorporate unit-level bar codes—especially denser, two-dimensional matrix-type bar codes—into their product packaging. These bar codes need to be accurate. Inching its way over the pharmaceutical labeling horizon is RFID technology, which is slowly emerging as one of the most effective ways to increase supply-chain efficiencies, protect the U.S. drug supply, and provide a means to track and trace products. According to Fowler, a recent FDA report encouraged all pharmaceutical drug manufacturers to undertake an RFID pilot, pending such time as the cost of RFID technology makes it a more practical solution for industrywide implementation.

NOSCO is an independent advisor and a member of EPCglobal, a body leading the development of standards for the Electronic Product Code (EPC) in support of the use of RFID technology. “There’s a huge impetus for companies to get into this, based on the potential to fully track and trace where drugs are bought and sold,” Fowler says, “but like anything else, there are obstacles to implementation, such as cost and infrastructure.”

Zero tolerance for error

FDA policies govern the content, format, and placement of pharmaceutical labels. Accurate, user-friendly placement of copy and graphics, as mandated by the FDA, requires that certain information appears in a specified sequence, making it easier for healthcare professionals and consumers to use the information without making dispensing or usage mistakes. And while prescription or “ethical” pharmaceuticals are bound by stricter labeling guidelines than over-the-counter (OTC) medications, “We can’t make mistakes anywhere,” Fowler says. “After the FDA approves the copy, it has to be perfect.”

Proofreading pharmaceutical copy presents its own special challenges, such as the use of nonstandard fonts, special characters, and symbols. Fowler says, “You may not think a decimal point would matter, but if you miss one you may also have given the patient 10 times the recommended dosage.” Most of NOSCO’s work arrives ready to go in the form of the native file with fonts. “While we sometimes will do submissions, usually we just preflight, prep, and tweak the customer file,” he notes.

It may be a brave new soft-proofing world outside. But inside the realm of pharmaceutical packaging, it’s the hard copy that counts. “We do electronic approvals under strict rules,” Fowler says, “but we like to work in a hard-copy world, and we check and double-check that hard copy for accuracy. And, we don’t take electronic files from just anybody.” When the price of a printing error could be as high as going out of business for a pharmaceutical manufacturer, Fowler adds, version control is also a huge concern. “We control that quite a bit,” she says. “I have to make sure I have only one version of a file on the system at any one time.” This is not always as simple as it sounds, since “our customers don’t always tell us when they’ve revised or obsoleted copy.”

Quality comes first—and last

In addition to fulfilling FDA requirements, most pharmaceutical packagers operate according to the requirements of cGMP (Current Good Manufacturing Practice) and QSR (Quality System Requirements). Needless to say, the extra steps that must be taken in conforming to quality standards have the potential to quickly escalate the cost and extend the time it takes to ready a pharmaceutical package for market. This places an enormous burden on converters, whose charter is to scrub costs and labor from the process and deliver product on an accelerated schedule. As such, it also represents an acid test for workflow systems that must facilitate data entry, editability, access, and collaboration flawlessly without compromising the accuracy and security of the product. At NOSCO, says Fowler, an Artwork Systems workflow, Novell server, and strict internal SOPs ensure that sensitive information is tightly controlled in the most efficient and cost-effective manner.

To paraphrase Wendell Phillips, eternal vigilance is the price to be paid for product safety and security in pharmaceutical packaging. But considering that the potential cost of error can be extremely steep, it’s a small sum indeed. pP