The Devil’s in the Details of New Good Manufacturing Practices Rules

21 CFR 117 is must reading, not only for food safety but production efficiency and a tighter supply chain.

By Kevin T. Higgins, Managing Editor

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The Bible is a mashup of two testaments that aren’t always in sync. While one speaks of vengeance (“eye for eye,” Leviticus 24:18), the other talks of forgiveness (“turn to them the other cheek,” Matthew 5:39). Confusion is inevitable.

The bible of food processing can be found in Title 21 of the Code of Federal Regulations. For years, conscientious processors turned to part 110 for guidance on good manufacturing practices. The essential rules of the Food Safety Modernization Act (FSMA) trump part 110 and replace it with part 117. For food manufacturers, the message is clear: There’s a new gospel, baby, and it’s time to ditch the old one.

Maybe they’ve turned away from the church of the federal code, or perhaps they’re too orthodox to let go of part 110, but many (probably most) food professionals have yet to read the revised code. In a recent on-line survey sponsored by Safety Chain Software and the Acheson Group, 29 percent indicated their companies were considering the new supplier compliance rules, and another 22 percent said they weren’t considering them.

Those rules, detailed in subpart G of 117, put the onus on processors to assess, validate and document that the facilities that ship them raw materials and ingredients are in compliance with FSMA. And by source, FDA doesn’t mean Mega Milling Co.; it means the mill from which the flour was made. Merely “considering” auditing that mill or reviewing independent reports of the mill’s compliance places the receiving plant in the crosshairs of inspectors and makes the company a candidate for the exemplary shutdowns that will occur later this year and in 2017.

Foreign supplier verification received a lot of attention in the run-up to final FSMA rules, but the innocuously named current good manufacturing practices (cGMP) make clear the same if not more rigor is expected in analysis of domestic suppliers. Sorry, no mulligans granted for purchases on the spot market.

Fundamental change, not more paperwork and good intentions, is the essence of FSMA. “Raw materials are one of the biggest areas where there will be issues,” asserts Robert Rogers, senior advisor-food safety & regulation for Mettler-Toledo’s product inspection group, Tampa, Fla. Because the rules are deliberately nonprescriptive, food companies need to understand the spirit of the law and then devise a plan for compliance.

To illustrate, Rogers cites the regulations specific to package labels. Mislabeled products are the leading cause of recalls, particularly when undeclared allergens are involved. The labeling process is specifically identified as an element of the hazard evaluation that processors must conduct. Human error often is the cause of mislabeling, but a simple “oops” won’t suffice as a response; process changes to prevent a repeat are required.

When Nestle/Dreyer’s Ice Cream added lines to its Bakersfield, Calif., plant in 2005, undeclared allergens already were a concern, so the firm commissioned Huhtamaki to incorporate a 2D reader that would scan every carton flat entering a forming machine to ensure the carton code matched the ice cream being filled. Today, off-the-shelf vision systems are available on form/fill/seal machines like those from TNA North America — but as an option, not a standard component.

Vision technology alone is insufficient; it needs to be driven by “a comprehensive program designed around it,” Rogers emphasizes. Feeding the wrong carton or film into a machine is a known risk. While FDA deliberately avoids prescribing fail-safe technology for high-speed fillers, processors will find it easier to incorporate “a vision-controlled labeling process” than, post recall, to “explain why you don’t need technology after you have considered the risk of contamination,” he says. “The risks are there; figure out how to control them.”

Beyond the four walls

Inspection technology is a good starting point for in-plant improvements. The greater need is improvement throughout the supply chain, however. “Raw materials are one of the biggest areas where there are issues,” Rogers points out. He characterizes FSMA as a first step toward the supply-chain controls that have existed for years in pharmaceutical manufacture and distribution.

Item-level coding and documentation for drugs are geared toward anti-counterfeiting efforts, though there also is a safety overtone. “The food and beverage industry is foolish to think that pharmaceutical tracking of where raw materials come from isn’t going to be a requirement in the very near future,” he believes.

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