My advice is, don’t focus on preparing for the inspection; focus on your operations and their state of control.
Don’t wait for the FDA to tell you what to do, or to point out what needs to be corrected.
Far too often, companies are too worried about doing things that they think the FDA wants them to do instead of
understanding their own processes and doing them properly. If you have a good system for making decisions and
developing process that is based on good science and you can defend the system, then there’s usually nothing to worry about. If you’re in a daily mode of preparedness, then you shouldn’t have any problems with inspections. The real problem is when we go in and we see processes out of control, with firms that have little process understanding. It’s not enough to say that a consultant told you to do something, or that your company has been doing a certain process for so long that it must be a good process. You have to understand your own processes and be able to justify that they are in control.
