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Environmental Quality Corner with Ken Appel

FDA Compliance

Congress Can Wait… But the FDA Won’t

The FDA’s new enforcement culture won’t compromise public safety

Published: Wednesday, June 30, 2010 - 07:14

For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S. citizens who care about any issue and how our legislative process resolves the problems of our time—no matter what their party affiliation or how deep-felt their political beliefs.

However, it would be a mistake to read headlines about legislative stalemates and believe that government has ground to a halt. Quite the contrary. Anyone whose job is to oversee quality in government-regulated environments should be aware that administrative agencies generally are acting more aggressively whenever and wherever they can.

This is especially true of the Food and Drug Administration (FDA). This spring in fact, FDA’s chief counsel, Ralph Tyler, explained that his department’s role is to define policy and enforcement goals in the event that a stalled Congress doesn’t provide for decisions that will safeguard public safety. His view, which we now see as a significant part of the 2010 FDA culture, is that if Congress hasn’t gotten around to a key concern that affects public safety—vis-à-vis food, drugs, or medical equipment—the FDA can and should take action. If Congress stipulates a change of direction, we’ll see if any of the advocacy positions taken by the FDA are reversed, but so far there is no evidence to think that this is the case or will be. 

Another example of the more aggressive FDA stance is the sheer increase in numbers of inspections and consequently, increased reports of good manufacturing practice (GMP) deviations, in the life sciences industries that the FDA oversees. It’s not necessarily the case that Form 483 letters (i.e., observations or warnings based on negative inspection results) are on the rise because pharmaceutical processors or medical device manufacturers are newly sloppy. (See “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments” for example.) Rather, this is likely a reflection of more aggressive inspection schedules.

The increase in the number of inspections is a new and far more effective method that is reportedly being used by the FDA (and its European equivalents) to target where these inspections are done. The FDA is far from the days when inspections occurred in reaction to complaints. Now, risk modeling drives inspection programs, often bringing inspectors to new terrain such as high-risk Asian processing plants, where many active ingredients used in formulations are sourced. Pharmaceutical manufacturers with globally distributed manufacturing facilities with the equivalent of in-house FDA oversight to ensure quality standards have little to worry about. However, any company that has taken quality shortcuts by sourcing from plants using low-cost labor without sufficient quality management methods would be well-advised to work overtime to ensure their managers catch quality problems before FDA inspectors do. Either your company’s in-house quality assurance management catches any quality problems inadvertently introduced to your operations by suppliers, or you run the risk of widely publicized FDA notations of GMP failures. 

The FDA would not be devoting significant resources to overseas inspections if its risk-based modeling did not give irrefutable evidence that this is where the greatest returns will be in ensuring public safety. However, quality problems can and do occur with local suppliers as well. Any FDA-regulated company should know in granular detail the steps that all its suppliers have taken to ensure product quality, such as safeguarding temperature and humidity conditions in processing, storage facilities, and transport if and when required.

Pharmaceutical ingredients that are contaminated make for bitter pills the public won’t swallow. Type-three medical device components that cause even one fatality will not be tolerated either. 

If you suspect the sources your company uses don’t have complete records for environmental monitoring and alarming that can demonstrate FDA compliance, know that your company is, unfortunately, not alone.

At Veriteq, now a Vaisala company, it’s my job to keep an ear to the ground to see how regulatory enforcement is operating in the real world. Some common practices could be called into question, such as the widespread use of monitoring instruments whose manufacturers don’t mitigate risk by ensuring data are correct. For example, the stipulation that instruments will remain in specification until the time of the next calibration. Seldom is the question asked about instrument stability in between calibrations. An instrument that doesn't hold its calibration makes all the measurement data suspect up to the previous calibration because no information will be available as to when the instrument went out of specification. Using monitoring instrumentation without such stipulations—i.e., documented evidence with correct data—could jeopardize the quality and safety of your products. 

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About The Author

Environmental Quality Corner with Ken Appel’s picture

Environmental Quality Corner with Ken Appel

Ken Appel, author of Quality Digest’s Environmental Quality Corner, is manager regulated markets for Veriteq, a Vaisala company. Veriteq provides environmental monitoring of temperature, humidity and other critical variables in controlled environments for regulated industries and other critical storage applications where product loss or audit failures are unacceptable.