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.
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