So, what are some of the things that we need to do to get ready for the next FDA inspection?

First of all, we need to get into the habit of holding practice sessions so that we can drill anything and everything that can come up in the inspection process. It’s a good idea to look at the historical review file that will have been recorded from the last few inspections as this will give you a good idea of some of the things that the agency has an appetite to look at. If we know of areas of weakness that we need to focus on, we can spend time to ameliorate those as much as possible so that they don’t become exposure points during the inspection. Ultimately you need to put a plan in place to fully remediate those, hopefully before the next inspection.

It’s important to involve management in the process, but never let them give the whole story. Better to restrict them to an overview of the overall process and facility but let that subject matter experts address the majority of the issues that are likely to be of interest to the inspectors.

When it comes to reviewing investigations, always have the individuals present that were responsible for writing the investigations, since they will be the most likely people to be able to address the detailed questions as the inspectors probe and try to understand your rationale and your conclusions. It is important for the company management to address with the whole staff the company’s regulatory responsibility to the FDA, so that there is a clear and uniform approach and understanding to what is required.

As the FDA inspectors arrive at your site, make sure that the receptionist and security guards are appropriately briefed, so they efficiently contact the individual’s assigned to accept the inspection form 482 from the lead inspector. Preferably this should be the head of quality for the site. Always assure the inspection process is professionally facilitated and where possible this should also be the site quality head. Because of the frequent unannounced arrival of the FDA at your site, the Site Inspection Team should always have an inspection backup in case the site quality head is not available. You cannot postpone an FDA regulatory inspection!

In order to generate a good atmosphere and congenial relationship with the FDA inspectors, always, always, always assure request for documents are satisfied in a timely manner, which should not exceed 30 minutes. Doing so is likely to incur the wrath of the inspection team and will add to the stress of an already stressful process.

When possible, always avoid refusing the FDA inspectors their requests. Again, to do so will most likely generate an unfavorable atmosphere, which will not aid in a smooth or favorable inspection process. If possible, assure that all records can be made available electronically by providing appropriate electronic systems, but make sure any material transferred to data storage devices and given to the inspectors is appropriately encrypted. They will be checking to see if you have a Data Integrity Policy and whether you follow your own procedures!

As you arrange for these electronic systems, review your data and files and be mindful of the fact that the FDA is not permitted to operate your equipment. As a result, it is important to have an appropriate individual on hand to manipulate that in such a way as not to expose documents or data sets that should be held confidential. This is particularly important if the documents are not relevant to the inspection process being examined. This is particularly important for pre-approval inspections for a new product.

Some basic important facts that all employees should know include:

1. What is the quality policy for your site? This is a very fundamental requirement on one that the inspector will expect all employees to know.

2. Another important question could relate to what is required for you to do your job?

So, it’s very important that these very basic and fundamental questions are practiced so as not to lead to ambiguities which might lead one to question whether or not the employees have been appropriately trained. This will be a fundamental red flag for all GMP inspections. One way to avoid this is to assure that your training content and trainers remain current, so it is vital that these are reviewed on a regular basis to prevent unnecessary citations being issued during the inspection. One way to stay current in this respect is to have a qualified consulting group audit your material on a regular basis and to offer suggestions with respect to how best to update material to keep it fresh and relevant.

If one does this, you will always remain head of the curve and you have no fear of what to expect during routine FDA inspections.