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Hazard Analysis and Risk-Based Preventive Controls Fundamentals

Most types of food facilities are mandated by the FDA to incorporate plans for Hazard Analysis and Risk-Based Preventive Controls (HARPC). While much of the same areas can be addressed by a Hazard Analysis and Critical Control Points (HACCP) program, there are a few basic variations.

In regards to hazard analysis, HARPC plans must take into account any “reasonably foreseeable” hazards or any that may be known, for that matter. Along with the ones that are usually identified in a HAACP plan, these hazards may also be allergenic or radiological, for example.

Preventive controls may be used at points beyond critical control points. Sanitation and the supply chain controls are a pair of examples. A recall plan is necessary if an identified danger needs supervision. It may not be suitable to provide essential limitations on all preventive controls. They can instead have “parameters” and “values” that are not inherently numerically calculated.

For CCPs, supervision is required, but for other protective controls, it may not be required. It could be important to track the FDA compliance status of vendors. Corrective measures are required where controls are unsuccessful in mitigating or removing a threat. Instead, “corrections” are minor, fast modifications that fix isolated concerns that do not specifically affect food safety.

UReg FDA Registrations is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.

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