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Tips on Preparing for an FDA Inspection

By: Bruce McDuffee

Are you following current good manufacturing practices?

If youre in the business of manufacturing drugs, medical devices, nutraceuticals, ormanufacturing or importing any product in the United States that falls under currentGood Manufacturing Processes (cGMP) regulations, your facility will be inspected bythe U.S. Food and Drug Administration (FDA).

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According to the Federal Food, Drug and Cosmetic Act, Registered domestic drugestablishments shall be inspected by the FDA at least once every two years. Undersome conditions the inspections may be even more frequent, such as when a drug isbeing manufactured for the first time, if there have been previous problems validating asimilar process, if production of a product or a new process is substantially differentfrom 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 beprepared?

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What you should expect

Will the inspector just show up at the back door and sneak in for a quick look, or is it amore formal process? You may or may not receive notice; inspectors have been knownto show up unannounced and there is no requirement that they provide you notice. Butthey 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 withFDA form 482 [1]. If you are not presented with the form, be sure to ask for it. Theinspector should also show an official FDA identification for your review. The form 482clearly states what an inspector may inspect and what information is off limits: An inspector may enter, observe, collect samples, interview employees, and reviewany 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 researchrecords.

What is the inspector looking for?

The best place to start is to read the FDA document Investigations Operations Manual(IOM) [2]. The IOM is the primary guidance document on FDA inspection policy andprocedures for field investigators and inspectors. In general, they are looking foranswers to the following questions: Are you following cGMP? Is your staff knowledgeable and familiar with regulations and cGMP? Is documentation available demonstrating training, monitoring, and compliance

programs?

From the IOM, the FDA will audit and assess any available process validationprotocols, activities, data, and information, whether or not completed, and report to thefirm any deficiencies.

Attitude does matter

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 systemsand processes. Obviously, inspectors prefer the latter.

Its human nature to dislike an inspection of yourself or something in which you arepersonally invested (like a department or a company) because it usually involves somelevel of criticism. However, think of criticism as a good thing. In this case, its meant tohelp 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 usefulinformation 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 industryprofessionals who are involved with regulatory compliance or monitoring andmeasurement in controlled environments. Vaisala will also be offering free webinars

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starting in April. For more information, e-mail bruce.mcduffee@vaisala.com [3] or stopby booth No. 2045 at the Interphex [4] conference scheduled for March 2931 in NewYork, where pharmaceutical and biotechnology professionals, drug manufacturers, andcontract service providers meet.

About The Author

Bruce McDuffee is the marketing manager for the Life Science and High TechnologyDivision of Vaisala which provides measurement, monitoring, and validation solutionsfor controlled environments within the pharmaceutical, medical equipment, foodprocessing, and semiconductor manufacturing industries. McDuffee holds a bachelorof 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 instrumentationindustry. McDuffee teaches humidity and current Good Manufacturing Practices(cGMP) seminars throughout the United States.

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Source URL (retrieved on 04/20/2011): http://www.qualitydigest.com/inside/fda-compliance-article/tips-preparing-fda-inspection.html

Links:[1] http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127428.pdf[2] http://www.fda.gov/ICECI/Inspections/IOM/default.htm[3] mailto:bruce.mcduffee@vaisala.com[4] http://www.interphex.com/

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