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FDA’s Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice (Part 2 of 3)

Registrar Corp continues its effort to update industry regarding U.S. Food and Drug Administration (FDA) Regulations. As stated in Part 1 of our analysis, the U.S. FDA has proposed new rules for the food and beverage industry. FDA’s proposed Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food has two major parts. First, it contains new provisions requiring hazard analysis and risk-based preventive controls. Second, it would revise the existing Current Good Manufacturing Practice (cGMP) requirements found in 21 CFR part 110. Today, Registrar Corp presents on the revisions to FDA’s Current Good Manufacturing Practices (cGMP).

FDA’s cGMPs are the regulations published in 21 CFR 110 that address the processes necessary to ensure that manufactured food is safe for consumption. The regulations describe the minimum requirements for personnel, plants and grounds, sanitary operations, facilities and controls, equipment and utensils, processes, warehousing, and distribution.

FDA is proposing to modernize the existing cGMP (21 CFR part 110) requirements, and businesses already subject to part 110 will be subject to the modernized cGMPs that would be established in the proposed 21 CFR 117. FDA’s existing cGMPs (part 110) will remain in place and in effect for compliance purpose until all business have reached the date when they must be in compliance with FDA’s modernized cGMPs (part 117).

FDA’s cGMP regulation would be modified to clarify that certain existing cGMP provisions requiring protection against contamination of food also require protection against cross-contact of food by allergens. Further, language in the regulation would be updated and certain provisions containing recommendations would be deleted. In addition, FDA is requesting comment on whether it should mandate training for employees and supervisors, including a requirement for records that document training, and whether it should require, rather than recommend, certain provisions, such as cleaning non-food-contact surfaces of equipment as frequently as necessary to protect against contamination of food and food-contact surfaces.

Generally, cGMP provisions would still apply to facilities that would be exempt from the hazard analysis and risk-based preventive control requirements or that would be subject to modified requirements.

The new Food Safety Modernization Act (FSMA) will result in the implementation of a new approach toward GMPs, with a focus on preventative controls for all food manufacturing facilities. Food manufacturers will be required to conduct hazard analysis and develop written plans to address and minimize potential hazards in their manufacturing processes. The U.S. FDA has not finalized the proposed rule for cGMPs. Currently, the FDA is taking comments on the rules until February 15th. For any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

Continue to part 3 of this article series.