FDA Regulatory Compliance
Food and Drug Administration (FDA) Services
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities. The Current Good Manufacture Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods regulation is part of FDA’s implementation of FSMA.
First, the Preventive Controls rule modernizes FDA’s long-standing current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food.
Second, the PC rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. As part of the rule it is also required that each facility have one or more “Preventive Controls Qualified Individuals PCQIs” responsible for the development, implementation and maintenance of the firm’s food safety plan. To address this requirement the Food Safety Preventive Controls Alliance has developed a standardized curriculum recognized by the FDA as one way to meet the requirements for a PCQI.
HCG Preventive Controls Training
The HCG has qualified Lead Instructors available to provide public or in-house Preventive Controls training to address the requirement of the PC regulations. Students attending the PC training will receive a certificate as a Preventive Controls Qualified Individual.
HCG HACCP/PC Training
To accommodate the needs of the food industry where it might be necessary to have a HACCP plan as part of a Global Food Safety Initiative program and a Preventive Controls food safety plan to meet FDA requirements, the HCG has developed a combined, and recognized, training program to meet both needs. This HACCP/PC training program has been recognized by both the International HACCP Alliance (IHA) as well as the Food Safety Preventive Controls Alliance. As a result, students receive both a HACCP Certificate with an IHA seal as well as a Certificate as a Preventive Controls Qualified Individual.
Assistance in Development Food Safety Plans and Systems
HCG Professionals can conduct GAP analyses of food plants’ food safety plans and systems as well as assist food plants to develop, implement and maintain food safety plans in compliance with FDA regulations. HCG professionals can also assist plant management prepare for FDA investigations by reviewing its food safety plan and system, GMP/Prerequisite programs, supporting documentation, process validation documentation, plant pathogen control programs, plant sanitation procedures and plant records.
HCG Recall and Crisis Management Assistance
There can come a time when even the best run plant can find itself in a recall or crisis situation. An ingredient supplier might change formulations or an employee may mistakenly release product under testing. If not handled correctly, these situations can bring all plant operations under a regulatory microscope and cause uncontrollable operational or in the worst cases, legal costs.
Having a HCG professional at your side can help contain a crisis and put a plant back in operation. HCG can help investigate the cause of the crisis, suggest actions to prevent the risk of further occurrences, act as a liaison between plant management and regulatory personnel, and assist with responding to government enforcement actions in order to return plant operations to a state of compliance.
The HCG can also offer assistance to plants addressing FDA’s FD 483 findings Letters of Warning, positive finding of pathogens in ready-to-eat products, etc.