What’s wrong with this picture?
On a typical workday, you may see nothing wrong with this picture…but place an FDA Investigator or other regulatory Inspector in this room, and you may it see differently. I’ve had the opportunity to work as an FDA Investigator working in the GxP (primarily GMP) world. I left that career and transitioned over to the industry (AKA ” the other side”) in GCP starting out as a Clinical Research Associate (CRA).
As an FDA Investigator inspecting all types of manufacturers, I was accustomed to reviewing documents in immaculate, spacious conference rooms. When I became a CRA monitoring clinical sites, however, I had a rude awakening and was quickly humbled by my designated monitoring space. There were no spacious conference rooms…sometimes no room at all. With some sites, I was placed in a small cubicle. With other sites, I sometimes shared the busy desk of either the Principal Investigator, Sub Investigator or Study Coordinator.
But the most memorable experience was when I was placed in the break room /copy/printer room where I shared a table with documents and binders from other trials and was entertained by interesting (and sometimes incriminating) conversations from site staff.
At that point, I couldn’t help but reminisce on my prior career as an FDA Investigator thinking “Boy, would I have a field day if I were an FDA Investigator placed in this room!”
But I’m no longer an FDA Investigator…I’m on the “other side” now, training others on audit/inspection readiness and providing tips on how they should prepare and set up appropriately for an inspection.
Important tips to know when it comes to set up is to adequately prepare your staff and facility including inspection and support rooms.
FACILITY AND STAFF PREPARATION
When preparing the facility, for an on-site audit or inspection, select a private area, or conference room that has a phone and, a copy machine for document requests. It is important that other areas such as work areas and printing rooms are clean and free of loose documents.
Finally, support areas or affiliated departments such as the pharmacy and or laboratory should be assessed to ensure all documents and staff are inspection-ready.
Also post designated signs throughout nearby areas notifying others of the inspection to ensure all nearby conversations are minimized during the inspection.
INSPECTION ROOM VS SUPPORT/WAR ROOM
The Inspection Room should be a quiet, private and paper-free located near the Support/War Room. This room should also be set-up with computers and screens for the FDA Investigator to review records and electronic systems used in the trial.
The Support/War Room which is a combination of clinical site and sponsor support, should be equipped with working electronics (such as email, printer, Instant Messaging) and dedicated to providing all needed documentation for the inspection.
In order to fully prepare for an audit or inspection, you must consider the rooms in your facility as part of readiness planning and preparation. After all, LOCATION MATTERS!