Katherine Ulman, global regulatory compliance manager for Dow Corning's Healthcare business segment 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."
To make the point, Ulman offered these highly plausible scenarios: “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, Dow Corning explains, which in turn is prompting the world’s regulatory agencies to not only generate warning letters and product recalls but also work to develop new standards and regulations focusing on the raw materials used in drug and device manufacture. According to Dow Corning, this can be especially tough for manufacturers working to develop and commercialize combination products.
According to the U.S. Food and Drug Administration (FDA), its 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."
Suppliers with highly integrated supply chains have greater control over raw material changes that could inadvertently impact end-product performance says Dow Corning.
"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 … 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."
Ulman points out that working with trusted suppliers can help reduce supply-chain risks and help companies 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, and
• Manufacture and test their materials to ensure that they comply with regulatory requirements in different countries.
Dow Corning says it offers lines of silicon-based performance-enhancing materials 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."
Information about Dow Corning at dowcorning.com/healthcare.