The Clock Is Ticking Part 2 – 15 Days To Respond to 483

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The Clock Is Ticking Part 2 – 15 Days To Respond to 483

April 29th, 2013 // 4:37 pm @

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This is part 2 on our article detailing how to respond effectively to your FDA 483 within 15 days.

It is also very helpful for a drug company to have a review of quality system management, or QSMR, during the 15 days you have to respond to the 483 for cGMP violations.

In a perfect world, we would have all companies do this meeting every quarter. But the reality of business is that many companies just wait until the FDA audit and problems emerge. You should consider having a short QSMR that is focused just on the 483 cGMP violations and all activities associated with it. This will allow you, for all 483 observations, to go several steps beyond the basics. The first step that everything thinks of is something like this –

Ok, we were cited for this issue with change control, so let’s take a look at the change control processes.

What you should do is to go beyond that by coming up with a list of metrics that can reveal where you are right now, where you will be in a few months and how things are improving. So, in the case of change control problems, one metric might be the quantity of change controls, or maybe the rate of turnaround. Or, perhaps the quantity of minor fixes, post change control.

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Having metrics such as these do two things for your company. First of all, they are just wonderful for management. It is very clear that progress is being made and you are productive. Metrics are easy for everyone to understand. Second, FDA loves metrics because they show documented prove of progress.

For instance, think about which argument is more powerful:

  • We updated our processes for change control so they are more streamlined and so they will reduce risks of omitting signatures, OR
  • We revised the change control processes – today, manufacturing cycle times have fallen from 29 days to 24 days, the quantity of change controls went down by 45%, and the rate of product rejection went down by 4%.

It is important for you to have this QSMR during those first fifteen days after the cGMP inspection. If you don’t do that, it is very easy to just go back to your normal routine, which is what FDA cited you for. If you can have a short QSMR that is focused just on the 483 violations, which should take only about 72 hours, you are going to be thinking more proactively about quality and how to keep it under a state of control in a cost-effective way.

Consider Conducting Mock Inspection and Gap Analysis

After you have gotten past the 15 day response, you should think about hiring a consultant to do a mock FDA audit for when FDA comes back. Also, consider doing a gap analysis. Do not just limit the consultant to your 483 problems. Always remember that a 483 is a symptom and FDA is going to use the 483 in the future just as the starting point for the new inspection.

You will want your consultant to show you the issues that you are having from the FDA 483 perspective, but ALSO you want your consultant to point out other issues, such as, say, clean room training. Maybe your training is not effective, and while it is not included on the 483, you still want this to be pointed out to you and your quality team.

You want to find aspects of your quality operation that are related to the 483, so you can illustrate to FDA that you are doing more than the minimum. FDA always views its regulations as minimums. They want you to just start there, not finish there.

Then, you should review the findings of your mock audit and your gap analysis. After that, set up projects that deal with any gaps found and will enable your business to thrive in the next 2 or 3 years.

H/T: Cerulean Associates

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