A Tour of the FDA 2017

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A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.

So, what is a tour of the FDA like?

A tour of the FDA helps to get a broad understanding of the this regulatory body and get some idea of the various departments it has, as well as the functions of these departments. To get an understanding of what the FDA does, a reference to its mission statement could give some direction:

“(The) FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” This is just the opening line of the FDA’s mission statement. Reference to its other statements, which have now included a reference to containing terrorism, will serve as a good guide to a tour of the FDA. In short, the FDA regulates nearly every item used and consumed by the American public.

The history of the FDA

The legal sanction for carrying out its mission is mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act). An amazing fact that a tour of the FDA reveals is that it is one of the oldest regulatory bodies in the world, with its earliest jurisdiction having covered regulation of drugs in the year 1848. The Department of Agriculture, to which President James Polk appointed noted chemist Charles Wetherill, can be considered the earliest endeavor to regulate medical products of daily use in the US.

How is the FDA organized?

A tour of the FDA is incomplete without a reference to the way it is organized. Its structure consists of this hierarchy:

  • Office of the Commissioner
  • Office of Foods and Veterinary Medicine
  • Office of Global Regulatory Operations and Policy
  • Office of Medical Products and Tobacco
  • Office of Operations

Under these broad heads, a tour of the FDA shows the way into which it is divided into several offices and organizations. Important among these include:

  • Office of Regulatory Affairs (ORA)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Devices and Radiological Health (CDRH)
  • National Center for Toxicological Research (NCTR)

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Calibration and qualification in analytical laboratories

Calibration and qualification in analytical laboratories is needed because laboratory equipment should demonstrate suitability for the intended use. The way to do this is by calibrating and qualifying them. Calibration and qualification in analytical laboratories are also necessary because they are subject to FDA inspections.

Laboratory equipment is high risk systems

Calibration and qualification in analytical laboratories are necessary also because laboratory equipment is high risk systems in that they impact product quality greatly. Because of this categorization, equipment calibration and qualification is a frequently cited deviation in FDA inspectional observations. They are also targets of warning letters. To avoid all these scenarios, calibration and qualification in analytical laboratories is called for, although it is possible that many times, companies are not sure on exactly which of their equipment they need to calibrate, qualify, test and document.

Important factors

Three important factors impact the reliability of analytical data generated from chemical and physical analyses critically:

  • How much validity the analytical methods used have;
  • The extent to which the instruments used for the experiments are reliable;
  • How well and how appropriately the analysts undertaking the calibration and training are trained

What does the FDA say?

The FDA’s c-GMP requirements (CFR – Code of Federal Regulations, Subpart I: Laboratory Controls, S211.160 (b) (4)) has this to say about the scope of calibration and qualification in analytical laboratories:

“The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.”

References:

http://www.cvg.ca/images/Qualification.pdf

http://www.labcompliance.com/seminars/audio/226/default.aspx

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