Perfect OOS Results Will Make FDA Investigators Suspicious

Perfect OOS Results Will Make FDA Investigators Suspicious

April 17th, 2013 // 3:37 pm @

More Exclusive FDA cGMP Compliance News

April 17, 2013

In one of our recent FDA inspection Webinars, we heard some more interesting tips about what FDA cGMP investigators are looking for during an inspection:

  • Marketed drug products that do not meet the specifications of the US Pharmacopeia. Many FDA investigators have a laboratory background, so this one is a favorite. Some companies will say that the product does not feature USP on the label, so what is the problem? However, is the product in the USP. If so, then it has to meet USP specs.

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  • How does your drug company handle OOS results? This is one of the most critical things that every FDA inspector is going to ask about. The key to remember is that they do not expect companies to be perfect on OOS results. Actually, if you show you are perfect in this area, FDA is going to be suspicious. FDA is going to call in inspection reinforcements if they see perfection alleged in this area. FDA understands that no one is perfect and every company has an off day. FDA wants to know how you are going to handle off days with OOS results. If something goes awry, what will your company do. The inspection is just a snapshot of what is happening at your facility at that moment. What happens when FDA is not there? FDA wants to see that you are ready if things go wrong, because they always do eventually.
  • Be sure your employees are all following the identical SOP. One of the big cGMP inspection items is to ask various personnel in several departments for the same SOP. FDA wants to see if the SOP on the floor, in the lab and in the upstairs office is the same, absolute SOP. If some employees are adding items to their own SOP manual and not making those changes universal, this can be a big problem.
  • If you had previous 483 observations in another inspection, FDA is going to look very closely that those problems were fixed. Be very careful about repeat 483 observations – FDA is often going to send you a warning letter for any repeats. FDA will want to see that you verified that the 483 fixes are working, and if any issues are recurring. For example, FDA might see violations in your chemistry side that are corrected, and then will see the identical problem on the microbiology side.
  • If you did not get a 483 in the past, the investigator will look at any other problems that have happened in the last year, including complaints, recalls and field alerts. If there were no recalls or complaints, then FDA is going to focus on problems that often happen at similar manufacturing plants.

Upcoming FDA cGMP Webinars for 2013 include:

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