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What Is the US Food and Drug Administration (FDA), and Why Is This Government Agency Important?
- The Food and Drug Administration is a federal government agency in the U.S.A that has a mandate to safeguard public safety and health under the Food Drug and Cosmetic Act (FD&C Act) by regulating prescription and over the counter (OTC) drugs, medical devices, combination devices, food, and cosmetics. They have elaborated the regulations around the FD&C Act protecting the public from adulterated and misbranded products in the medical, drug, cosmetic, and food arenas.
- The manufacturer and distributor of these products has to comply with the guidelines laid down by the FDA, because only then will their products be eligible for marketing and consumption as well as import into the United States market.
- The FDA possesses and frequently uses its enforcement authority to subject to companies to penalties for lack of compliance with the law and the regulations, including issuing warnings, fines, blocking import of products, and even recalls of non-conforming products. The Agency is responsible for ensuring high-grade quality, safety and security of pharmaceuticals, even vaccines, medical equipment, cosmetics, etc.
A failed audit of their products or production facilities can trigger these kinds of enforcement penalties. A violating company’s business is likely to suffer because of negative publicity and inability to sell and market their products in the US, and in many cases a business can shut its doors permanently as a result of FDA actions.
How to ensure that your quality management system meets FDA standards?
If you are a manufacturer of medical devices or pharma products, whether over-the-counter or prescription, or if you deal with food packaging or other food-related technologies, you must have a reliable quality system (good manufacturing practices) infrastructure so that you can face the challenges of the regulatory environment and meet the demands of a competitive market and avoid adulteration.
Make sure you follow the following guidelines to optimize your quality management system to ensure high-quality products/services and continuous regulatory compliance:
- FULLY AUTOMATED/COMPUTERIZED AND INTEGRATED QMS:
Quality systems/good manufacturing practices (GMP) are complex and difficult to handle, if not automated. Automation simplifies GMP and streamlines the processing system by performing the repetitive task at a faster rate, thereby reducing wastage of time, overall cost and enhancing overall productivity while maintaining compliance.
Similarly, a fully integrated quality management system (QMS) will help in improving operational efficiency and overall compliance by automating and streamlining the processes. An integrated, holistic QMS will facilitate enhanced communication between the task, information, and people, thereby providing a connected solution.
- ENSURE CONTINUOUS VALIDATION:
FDA guidelines state that it is necessary to be in a constant state of validation. The organization must revalidate their software every time they upgrade or change their systems. The validation process can require a significant amount of time and expertise. An automated and integrated QMS designed allows for continuous validation while reducing the time, effort and cost involved in the validation process and mitigating possibilities of non-compliance.
- INCORPORATE PERIODIC TRAINING INTO SYSTEM FOR CONTINUOUS IMPROVEMENT:
Ongoing employee training and continuous improvement ensure FDA compliance. Make sure that your manufacturing, as well as QMS employees, remain fully aware about the industry issues, regulations and the quality management solutions so that their work and resulting output complies with current quality standards. A quality system and good manufacturing practices (GMP) are only as good as the team constantly implementing and improving them.
Why work with a law firm specializing in FDA Legalities?
FDA rules and regulations are complex, and the compliance can get severely complicated. A law firm specializing in FDA cases will not only ensure that you comply with the rules and regulations, but they will make you aware about the possibilities of potholes in your strategy and how you can resolve them.
