By : Mark Andrew Woodcock
FDA Compliance is an integral part of manufacture in the food, drug and cosmetic industries, to ensure that the public is not put at risk from consuming or using any new or sustained products on the market. There are several aspects of compliance including Good Manufacturing Practise, packaging and labelling, marketing and other factors. As an agency of the Department of Health and Human Services, the FDA is enabled to issue laws and enforce these on the 95,000 regulated businesses under its authority. The FDA ensures regulatory compliance across a number of products including food (excluding red meat and poultry), drugs, medical devices, blood, biological products, and cosmetics. The sole aim of FDA compliance is to safeguard the health of consumers and maintain the quality of products.
Only when organizations integrate FDA Compliance into their working lifestyle instead of viewing it as simply another regulation, will the authorities, businesses and consumers be happy.
There are two major impacts that failure to comply can have; public injury and company prosecution. When a product is contaminated, packaged incorrectly or fails to meet any of the regulations, consumers are put at risk, their health may suffer and in extreme cases, this can result in death. If the ingredients listed on packaging is incorrect, allergic reactions are possible, just as when the strengths are confused accidental overdoses may occur. For companies who fail to comply with the FDA, there are several possible outcomes, all of which are harmful to the longevity of the business. Product recall and seizure not only damages profits, but it also damages the stock of the business, making it less attractive to trade with and buyers are less likely to purchase products off them. For serious defiance of FDA compliance, a business can be fined huge sums of money and individual employees can be subject to criminal prosecution and jail sentences if they are found to have put human life at risk. The FDA publishes a list of companies and individuals who have been barred from working in any of the industries covered by the FDA due to criminal and life threatening activities. This alone should put compliance at the top of an organisation's agenda.
Whilst many businesses see compliance and regulation as a hindrance to their productivity and effectiveness, the FDA is working to make its regulations easier for manufacturers to adhere to and less like a drain on resources and employee focus. Many of the regulations are open ended and general which allows managers to implement them to suit their individual business. Smaller organisations will require a different approach than larger companies and the open-endedness reflects this.
FDA Compliance covers record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling. All of these features work towards public satisfaction and safety, keeping the quality of food, drugs, cosmetics and other products under FDA regulation high, whilst allowing businesses to work in ways which suit them. There would be no point in enforcing all of these regulations if productivity was hampered and research stifled. These regulations still allow for advances in science and technology, but they put public safety as their top priority.
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