FDA Watch: Thinking like the FDA

By Mark Gunn
MGD Services

Those of us in an FDA regulated industry sometimes get caught up in all of the regulations and documentation and forget why the FDA is requiring us to create what seems like never ending documentation. At its core, the FDA has a very simple job, to assure quality.

The FDA is charged with assuring the quality of the products of the pharmaceutical industry. This can be manufacturing (GMP), laboratory (GLP), clinical trials (GCP), medical devices, etc. The FDA requires you to prove you have a quality process in place. They need to know the public can be assured that the products produced are safe and do what they were intended to do. The only way the FDA can be assured that quality is being met, is to demand that we prove it. And if you think about it, the FDA should not really be located in Washington DC. They should be located in Missouri, the “Show Me” state.

Thinking like an FDA auditor, no matter how scary that thought might be to you, is really very basic. They are much like a very inquisitive 5 year old. I don’t mean this to be demeaning any way. If you have ever explained a very complicated process to a 5 year old you know what I mean. After every statement you make the child follows it with “but why?” You then have to back your last statement up with another explanation. The FDA works much the same way. They really don’t have any choice.

For example:

FDA auditor: How do you know the data I am looking at is accurate and correct?

Client: We know who entered the data and we know that they are qualified to enter it.

FDA auditor: How do you know that they are qualified?

Client: We have their latest CV on file and it shows the training they have taken.

FDA auditor: How do you know they attended the training?

Client: We have a signed record of the class attendance.

FDA auditor: So you know that the person who entered the data is qualified to enter it. How do I know they are the ones that entered the data?

Client: We have done our Risk Assessment for 21CFR Part11 and we know we have to be compliant and we are…

And so the line of questioning will continue. But you get the idea.

If you think along these lines, you should be able to embrace what the FDA requires rather than avoiding it. Ask yourself these types of questions for any risk assessed task and you will understand why the FDA has the regulations and guidelines that they do.

The next time you have to make a change to a regulated process you have to be able to back up that change with all of the documentation necessary to prove what affect it will or will not have on your current validated process. For an auditor to assure quality, they must be able to prove that what they are observing is accurate. That is why the regulations and guidelines are in place, so that you can show them that you have a quality process.

And the Validation Library is the place where the FDA auditor starts to look. More on that next time…

Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com