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2014.07.21
Breaches in Supply Chain Security Increase Regulatory Scrutiny of Raw Materials Used in Medical Devices and Pharmaceuticals


Issues are compounded in the combination product market, where OEMs must comply with additional regulatory requirements

A pharmaceutical manufacturer makes an unannounced visit to the plant that produces one of its key raw materials, only to find that the plant doesn't even exist. A well-known medical device manufacturer has to initiate a global recall of its drug-eluting stent based on reports of a malfunction of the catheter used to deliver the combination product to the proper position within the blocked artery. Elsewhere, a seemingly insignificant raw material change deep in the supply chain negatively impacts end-product performance, threatening patient safety.

Unfortunately, scenarios like these are happening on a global scale, causing regulatory agencies worldwide to not only generate warning letters and product recalls but also to enact new standards and regulations focusing on the raw materials used in the manufacture of both medical devices and pharmaceuticals.

Katherine Ulman, global regulatory compliance manager for Dow Corning Corporation's Healthcare industry, says, "While the focus may be on raw materials, it is the OEM who is ultimately responsible for ensuring that the materials they employ meet the critical requirements of the applicable regulations."

This can be especially daunting for manufacturers who are working to develop and commercialize combination products.

Combination Products

According to the U.S. Food and Drug Administration (FDA), a combination product may comprise of any combination of a drug, device and/or biological product. The FDA's Office of Combination Products (OCP) assigns primary regulation of these products based on their primary mode of action (PMOA) – whether they act on the body primarily as a drug, a biologic or a medical device.

Ulman says, "Even if the product is considered primarily a medical device, it will still need to meet requirements related to the drug or biologic that is combined with it. This makes bringing these products to market and ensuring the safety of their supply chains even more challenging."

The Impact of Supply Chain Integration

Suppliers with highly integrated supply chains have greater control over raw material changes that could inadvertently impact end-product performance.

"The culprit isn't always a direct change to the material that the manufacturer is buying," Ulman says. "Sometimes the fault is with a material that goes into that material. An integrated supplier – one like Dow Corning, which produces most of the raw materials that go into its products – is in a much better position to know about and control those changes than a supplier that purchases many, if not all, of its raw materials from outside suppliers."

Working with Trusted Suppliers Helps Mitigate Risk

  • In Ulman's experience, working with trusted suppliers can help combination product manufacturers reduce their supply chain risks as well as get their products to market faster with fewer regulatory hassles. She recommends working with suppliers who:
  • Have a team of product safety and regulatory compliance experts who are willing to use that knowledge to help their customers navigate the constantly changing global regulatory landscape
  • Provide the appropriate level of regulatory approval support
  • Maintain dedicated, registered healthcare manufacturing facilities
  • Strictly adhere to current good manufacturing practices (cGMPs)
  • Operate in accordance with a robust quality management system
  • Provide comprehensive documentation on the traceability of their materials
  • Manufacture and test their materials to ensure that they comply with regulatory requirements in different countries

How Dow Corning Supports Medical Device and Pharmaceutical Manufacturers

According to Ulman Dow Corning offers one of the most expansive lines of silicon-based performance-enhancing materials in the healthcare industry - materials that are manufactured under appropriate cGMPs for their intended applications at dedicated healthcare materials manufacturing facilities that are registered with the U.S. FDA as both "Drug Establishments" and a "Medical Device Establishments."

All of Dow Corning's manufacturing sites around the globe are registered to the ISO-9001 Quality Management System standard, which helps ensure that the organization can continually deliver a reliable supply of high-quality materials to meet its customers' requirements for performance and consistency.

In addition to safe and effective materials, Dow Corning also provides comprehensive registration support and consultancy services.

"Because Dow Corning has a long history of developing and manufacturing safe, consistent and regulatory-compliant materials for both medical device and pharmaceutical applications, regulatory agencies around the globe value and seek out our opinion," Ulman says. "This makes us a valuable resource for customers who are working to mitigate their risks as they develop and commercialize combination products."

Complete information about Dow Corning's solutions for healthcare applications is available online at dowcorning.com/healthcare.

About Dow Corning
Dow Corning (dowcorning.com) provides performance-enhancing solutions to serve the diverse needs of more than 25,000 customers worldwide. A global leader in silicones, silicon-based technology and innovation, Dow Corning offers more than 7,000 products and services via the company's Dow Corning® and XIAMETER® brands. Dow Corning is equally owned by The Dow Chemical Company and Corning, Incorporated. More than half of Dow Corning's annual sales are outside the United States. Dow Corning's global operations adhere to the American Chemistry Council's Responsible Care® initiative, a stringent set of standards designed to advance the safe and secure management of chemical products and processes.

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