How to reach FDA PAI inspection readiness?
Whether you are given advance notice as part of an international inspection or have the FDA knocking on the door unannounced, it pays to prepare. Inspection readiness is essential! This preparation is a combination of awareness of what the inspector is looking for, understanding the history of your product and where potential issues lie, and evidence to demonstrate that you are working towards correcting those potential issues.
The “FDA Compliance Program Manual for Pre-Approval Inspections” provides a framework for the FDA Pre-Approval Inspection Program, the overall process, and instructions on how the FDA executes the Program. However, despite the amount of information available for a correct preparation, getting inspection ready always requires an extensive effort. Moreover, some companies are still struggling to become fully compliant to the requirement of the updated Annex 1.
Recently I was asked by Nanomi to help them prepare for an FDA PAI at their CMO. The company had submitted a long-lasting injectable and was therefore notified by the FDA about the incoming inspection. It was time to get inspection ready.
Begin with the end in mind
Steven Covey
Controlling the flow of information and people are key to a successful inspection and should be a major part of your ‘game plan’. The first tip is on setting up the inspection space and establishing roles and responsibilities for the host team. This involves having a front room and back room with team members assigned to each room who understand exactly what they are responsible for.
The above is something most companies have under control. The importance of mock audits and training of personnel is also normally well understood.
When preparing for an audit however I often see firms struggling with documentation. Reports are not stored properly, protocols history is not well documented, development report doesn’t tell a story. Sometimes you don’t even have reports or documents on technology transfer. All this documentation is part of the information that creates the foundation to support the product through its lifecycle. Understanding the process can at times really be more (or equally) important than the end product!
Some time ago I came across the below CMC maturity model. Copying it here since I believe it summarizes in the best way what a company should aim for: level 4 or 5.
With Nanomi the outcome of the FDA PAI was a successful one. It was a great pleasure to cooperate with people from literally all over the world to make that happen.
Until next one….