Secure to the Max
Pharmaceutical packaging raises the stakes on secure prepress workflow.
June 2007 by Jean-Marie Hershey
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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.
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.
Companies Mentioned:
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