martes, 15 de julio de 2014
FDA’s cGMPs and HACCP Regulations do Protect Your Company.
Drafting the world’s best compliance plan will do nothing to help if it is not followed
As Benjamin Franklin noted, and as countless authors have affirmed since then, an ounce of prevention is worth a pound of cure. That is the animating principle of two related sets of U.S. Food and Drug Administration (FDA) regulations affecting the food and beverage industry: current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Critical Control Points (HACCP). Proactive compliance with those standards may minimize your exposure to contamination outbreaks, severe recalls, government investigations, and lawsuits. It is probably also good business in its own right.
Overview of FDA’s cGMP Regulations and Related Programs: Like many acronyms that emanate from Washington, the cGMP and HACCP programs impose a variety of complex obligations and “suggestions” on FDA-regulated industries like the food and beverage sector. But the gist is straightforward. These programs generally require companies to establish—and ensure compliance with—best practices in the manufacturing and distribution of food products.
The theory is that by baking many quality control measures into the production, distribution, and retail service chain, it will be easier to prevent food safety issues before they reach the consuming public. And, in the event they do reach the public, it will be easier to identify the problem, identify the affected items, and conduct a recall or enforcement action.
Compliance Matters. The consequences for lack of compliance can be severe. FDA’s rules are intended to ensure the safety of the food supply, which is obviously a first-tier priority for FDA and industry alike. Products that do not comply are deemed adulterated under the Food, Drug and Cosmetic Act, which prohibits their sale in interstate commerce, among other things.Proactive compliance can minimize exposure to severe issues and collateral consequences. In principle, vigorous quality controls should reduce the risk of issues on the front end, or at least minimize them before they become widespread.
Suggested Next Steps. If your company is among the 25 percent of the U.S. economy regulated by the FDA, chances are you have a cGMP, HACCP and/or related plan in place. A good first step is to ensure that your plan meets the current FDA (and any state) requirements.You also may want to consider ensuring the appropriateness of your preventive controls, which often can be considered to include (i) training, (ii) audits, (iii) documentation and (iv) validation/evaluation.
Product quality issues happen; advance planning and cGMP/HACCP compliance can make them rare and manageable.