So, when the FDA arrives at your facility, the inspection team will present their credentials, which includes their badge and they will request to see the responsible person. When the responsible person arrives, which is usually the head of the site QA group, they will present form 482 which states why they are at your facility. They will request a meeting to discuss the pending inspection and your job is to escort them to a suitable room that is prepared as home base for the FDA site inspection team.

Note; at all times the inspection team will be watching and noting how you respond and how you deal with that arrival. In particular, whether or not your organized and if you are controlled or in a state of panic.

You do not want to be in a state of panic! Stay calm and organized!

At the inspection site room, the head of the QA group should set out the logistics for the inspection with the FDA representatives, and that will include any site safety training to enable them to safely move around. It’s also important at this point to establish ground rules and to introduce members of the company team that will be assisting the inspectors with the process. Typically this would include scribes to record questions and requests, runners that will take questions on documents from a back room where a complete set of copies of the signed documents will have been preassembled, and escorts who will accompany the inspection team on the tour of the facility.

Opening the meeting with the FDA the company should deliver a profile that describes the site facilities, the equipment, the products and the personnel organizational structure, and to do this with no more than 15 slides. It’s important to keep this concise and simple so as not to cause ambiguities.

In addition to the front room with the inspectors, there needs to be a fully equipped back room, often referred to as the war room, where every document that may be required in the inspection is ready and available to be viewed.

Today, FDA inspection teams do like to see electronic copies, so if these can be made available via a SMART screen in the inspection room, then this will be a significant advantage. If this option is selected, it’s important to make sure that the correct version of documents is available complete with the change history.

After the company presentation it’s advisable to present the most recent copy of the signed quality plan together with the full index of all the site procedures and share the proposed plan for the inspection tour of the facilities.

When it comes to document review, there is a priority sets of records that FDA will want to inspect /review and these will include but will not necessarily be limited to the following:

  1. An inventory of computer systems of validation
  2. A site data integrity compliance plan together with a status check
  3. Training on the site computer systems validation and data integrity SOPs that have been reviewed by personnel.
  4. A list of change controls related to validated systems and CAPAs on validated systems, for the last 18 months.

To help with all this process it is useful to have defined some things prior to sitting down with the FDA. These things will prove helpful and show that you are being transparent about the compliance status of the site. In particular, a very useful tool for the site inspection team is an inspectional binder, which contains key information relevant to the site.

This will enable the FDA inspectors to have access to information for referral purposes without continually asking questions which in some cases could be sources of ambiguity.

Information such as the site address, the site phone number, the presentation of the overview of the site, a site map, a list of the products made at the site, the workflows for these products, core suppliers, an index of recent audits and a list of any inspections by regulatory agencies.

These are all simple points of preparation but done well can make a world of difference to helping to manage a successful site inspection.

Read Part 1 here.