Bruce McDuffee
Published: Tuesday, March 15, 2011 - 05:30 If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (FDA). According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, such as when a drug is being manufactured for the first time, if there have been previous problems validating a similar process, if production of a product or a new process is substantially different from past operations, or when a process is particularly complex. The FDA has put out the word that it is ramping up enforcement efforts, so why not be prepared? Will the inspector just show up at the back door and sneak in for a quick look, or is it a more formal process? You may or may not receive notice; inspectors have been known to show up unannounced and there is no requirement that they provide you notice. But they are not allowed to sneak in the back door for a quick look around the factory. When the inspector does show up, announced or not, you should be presented with FDA form 482. If you are not presented with the form, be sure to ask for it. The inspector should also show an official FDA identification for your review. The form 482 clearly states what an inspector may inspect and what information is off limits: The best place to start is to read the FDA document Investigations Operations Manual (IOM). The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. In general, they are looking for answers to the following questions: From the IOM, the FDA will “audit and assess any available process validation protocols, activities, data, and information, whether or not completed, and report to the firm any deficiencies.” There are two ways to look at an inspection: as an intrusion and inconvenience to your normal business activities, or as a chance to tell your story and improve your systems and processes. Obviously, inspectors prefer the latter. It’s human nature to dislike an inspection of yourself or something in which you are personally invested (like a department or a company) because it usually involves some level of criticism. However, think of criticism as a good thing. In this case, it’s meant to help you comply with regulations so the products that you produce are good quality, safe, profitable, and helpful to mankind. It's important to understand what is expected and to be prepared for an inspection. Keep your eyes open for seminars (many of which are free) that may provide useful information in that regard. For instance, beginning in St. Louis on May 5 and monthly thereafter, Vaisala will offer free cGMP seminars in select cities for life-science industry professionals who are involved with regulatory compliance or monitoring and measurement in controlled environments. Vaisala will also be offering free webinars starting in April. For more information, e-mail bruce.mcduffee@vaisala.com or stop by booth No. 2045 at the Interphex conference scheduled for March 29–31 in New York, where pharmaceutical and biotechnology professionals, drug manufacturers, and contract service providers meet. Bruce McDuffee is the marketing manager for the Life Science and High Technology Division of Vaisala which provides measurement, monitoring, and validation solutions for controlled environments within the pharmaceutical, medical equipment, food processing, and semiconductor manufacturing industries. McDuffee holds a bachelor of science in civil engineering and served as a Surface Warfare Officer in the U.S. Navy for several years before entering the test and measurement instrumentation industry. McDuffee teaches humidity and current Good Manufacturing Practices (cGMP) seminars throughout the United States.
FDA Compliance Tips on Preparing for an FDA Inspection
Are you following current good manufacturing practices?
What you should expect
• An inspector may enter, observe, collect samples, interview employees, and review any records related to the production of the regulated product.
• An inspector cannot demand access to personnel data (except training records), financial statements, sales data (except shipment data), pricing data, or research records.What is the inspector looking for?
• Are you following cGMP?
• Is your staff knowledgeable and familiar with regulations and cGMP?
• Is documentation available demonstrating training, monitoring, and compliance programs?Attitude does matter
About The Author
Bruce McDuffee
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Comments
FDA Inspections
The most challenging aspect of an FDA inspection is that the standard that the inspector is auditing to is so vague, non-technical, and open to interpretation that a company can be audited three times by three different inspectors with three completely different outcomes. It is the "C" in front of "GMP" that will bring your company down in an inspection. The challenges just to a pharmaceutical QC laboratory such as ours are daunting: 1) USP standards aren't certified reference materials, but are proprietary consensus standards for which characterization data is unavailable to the user. As such, they aren't compliant to the industry standard for testing laboratories: ISO 17025. 2) Many USP methods contain gross scientific errors and can not pass a method validation challenge to demonstrate suitability for their use for the specifications USP materials are expected to meet. 3) The FDA places such significant obstacles to continuous improvement that they have kept the industry in the "dark ages" from a technological perspective. With public outcry that the FDA is to blame for every act of industry quality failure and an increased mandate to keep the public safe, the FDA finds itself trying to "inspect in quality" without the resources and tools to be effective. Given a lack of specific standards, companies find themselves trying to hit a moving target without any assurance that they are on the right track. "More must be better" ends up driving industry consolidation (smaller companies can't afford to implement the quality systems of larger companies) and increased costs to the consumer, without an assurance of higher quality of the final product.