Scary cGMP

In this Halloween season, I’m thinking of what could be scary in cGMP. One of the scenarios I came up with is an FDA inspection. Even though I worked at FDA as an inspector, doing PAIs for new biologic products, I have to admit that when I am working for a company that is having an FDA inspection, I still have some trepidation. Audits and inspections are always tough, because you don’t exactly know how it’s going to go; you just have to prepare as much as possible. Being well prepared lowers the fear level. In that context, a consultant can help with a mock PAI or mock inspection, but what else can a company do on their own to prepare for this possibly scary time? As it turns out, quite a lot.
There are many ways a company can ideally prepare for an audit or inspection. The whole group involved in GMP Production should do training on audit behaviors, know exactly who is doing what during the audit (scribe, presenter, SME, leader, etc.), know where the audit room is and the back room, know the logistics of the audit (paper, electronic, host, etc.) and other details which will allow the audit to hopefully proceed smoothly. In addition to training, I think it is helpful to do “walk throughs” which is sort of like management by walking around—taking tours through all the manufacturing and critical utility areas to make sure they are ready for inspection. This sometimes requires areas to have 5S tidying up. Also, performing internal audits is a good way to help people get used to answering questions and being more comfortable as interviewees. Sometimes scientists and engineers are more comfortable writing than speaking, and the speaking part has to be practiced.
Once all this is done, it can be very helpful to have an outside person, typically a cGMP consultant, to come in to pose as the FDA inspector, to get the site ready for the inspection and to ideally ask many of the same questions that the FDA is expected to ask. The internal audit just isn’t quite the same, because people typically respond differently to internal people that they know, and typically internal audits don’t use all the rather complicated logistics of an external inspection. For this reason, it is often very helpful to have someone with deep cGMP experience to come in as someone with outside eyes to run a mock inspection.
Hopefully all these ideas will make the FDA inspection less scary! Have a happy Halloween and don’t eat too much candy.