FSMA Compliance Tips from the Life Sciences Industry

With the Food Safety Modernization Act (FSMA) looming, the food and beverage industry faces some of the most sweeping safety regulations since Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which authorized factory inspections and established standards of identity, quality, and fill-of-container for foods.

For many food and beverage production companies, compliance with FSMA’s stringent new requirements can seem daunting—even as operating in a world where the threat of contamination, allergen exposure, or package mislabeling seems to be an inevitable part of doing business. Based on the “Food Quality & Safety Survey 2016” conducted by Sparta Systems, only 54 percent of respondents say their organizations are compliant with the finalized FSMA regulations.

Regulations Across the Board

The food and beverage industry is increasingly experiencing tighter controls similar to regulations that have been in place in the life science industry for years, including pharmaceuticals and medical devices. These life science companies have established many similar programs that ensure compliance to federal safety regulations—in particular, the need to partner preventive controls with supply chain traceability in identifying and managing the risks of a product recall.

Recall response planning is a critical element for any business, but food is especially vulnerable. A browse through the FDA’s recall database shows a preponderance of recent food-related problems—from a massive recall due to traces of Listeria in private-label organic frozen vegetables, to undeclared peanut allergens in private label grocery cakes and cookies. Many of the root causes of these issues could have been caught early in the supply chain process through improved preventive controls, including timely supplier audits.

In the past, most food and beverage companies and their suppliers relied on a certificate of analysis, documenting the understood agreement that the supplier had proper controls in place and was delivering a safe product. Now, under FSMA, food and beverage companies are accountable for the quality of their supply chain and must adhere to strict supplier process verification guidelines, including the requirement to share product data, conduct supplier audits, and conduct quality assurance testing. While this process may seem intimidating to food and beverage companies, supply chain traceability and QA are long-standing practices in life sciences. To ensure the highest standard of quality and preserve patient safety, pharmaceutical companies have processes in place to ensure adherence to current Good Manufacturing Practices. This vendor oversight extends to the increasing number of contracted manufacturers who do everything from supplying active pharmaceutical ingredients to commercializing and distributing products.

Conducting both internal and partner audits is also standard practice for pharmaceutical companies to gauge the robustness of their quality system. These audits effectively evaluate the company’s and suppliers’ alignment with the principles in the quality system, ensure consistent, high-quality production, and embrace a state of continuous improvement—the foundational aspects of a culture of product safety. All of these aspects are elements of FSMA.

More Defined Label Layout?

Another similarity between current life science practices and new FSMA regulations is the requirement to maintain supply chain traceability—something that pharmaceutical and medical device manufacturers have been practicing for years.

When the FDA passed the standardized labeling guidelines known as Unique Device Identification (UDI) and National Drug Code (NDC) for medical devices, the intention was to increase public insight into the item’s production history, while providing a more efficient way to identify and manage product recalls.

The key to identifying a product and its manufacturing lineage is the standardized barcode, such as the international GS1 Standard. The Global Trade Item Number in the GS1 standard means that the identification information on every product’s label has the same look and feel, printed in clearly identified human readable text.