By Nigel Smart
No matter how well prepared you may be for an FDA Preapproval inspection…when the moment comes, a lot of things can go wrong just because you didn't pay much attention to human factors.
Having an inspection of your processes and premises does not mean the FDA is against you and that they are going to destroy all your plans and projects. Therefore, dealing with the corresponding inspector shouldn't be a worrisome experience for you and your workers, nor should it be an occasion to treat people badly. As advised by most pharmaceutical consultants, organizing things in advance will save you a lot of anxiety prior to the inspection and will prevent you from making a lot of silly mistakes.
The following list contains a set of tips to bear in mind when dealing with inspectors during their visit. First, they will help you keep focused on the best attitude throughout the inspection, in order to make it a smooth, less distressing experience. They will also allow you to present a better, more professional image that will certainly count at the moment of evaluating your application.
1. ESCORT THE INSPECTOR AT ALL TIMES: Never leave him alone wandering around the building trying to find things by himself. He is visiting your plant of excellence, so give him an appropriate tour and limit his access only to records, facilities, and materials subject to inspection. Remember to act in a courteous and professional manner all the time. Aggressive behavior just because he happens to be an inspector will not help you at all to have better results.
2. LET ALL OF THE INSPECTOR'S REQUESTS GO THROUGH YOUR INSPECTION TEAM: Remember to assign clear roles prior to the inspection. Everybody in the team should know what is going on and what their task is at a specific moment. If everybody is clear on what papers are being analyzed, there is a better chance of foreseeing and preventing any mistakes.
3. BE HONEST AND DIRECT WHEN ANSWERING ALL OF THE INSPECTOR'S QUESTIONS: Watch your manners, too. Never engage in an argument with an inspector and definitely avoid arguments between peers in front of him. These will create a terrible impression, and you'll regret it later. If you don't understand something, kindly ask for an explanation. He'll be more willing to explain even sections of regulations if he notices you respect his job.
4. DON'T WAIT UNTIL THE LAST MINUTE TO PRODUCE EVERY DOCUMENT. Providing all documents in a timely manner will cause a good and professional impression. If you can't find a specific record, never tell the inspector that it is unavailable; just tell him that you can't locate it. Remember he'll be checking your cGMPs, so handling every document request with care is also important.
5. ATTEMPT TO CLARIFY OR CORRECT MISUNDERSTANDINGS OR ASSUMPTIONS: Never guess what the inspector is thinking. If you encourage him to discuss his observations at the moment they are performed, you'll have more chances to clarify any misunderstandings or correct any information that may be mistaken. Don't volunteer information; provide full and complete answers. Don't go beyond that point.
Though it is not possible to guarantee success in your FDA Preapproval inspection, preparing in advance will certainly help you and your people feel less anxious at the crucial moments. Organization and respect are also key elements to bear in mind when facing this type of experience. Follow the advice of an appropriate consultant in the pharmaceutical area to present your application in the best way but also to face this inspection. Don't torture yourself by improvising the inspection visit. You already have the best product and the best plant…and you follow the best cGMPs, why spoil the impression with the wrong attitude? Mind your manners and everything will be fine.
Nigel Smart is a pharmaceutical consultant with extensive experience in the biotechnology and pharmaceutical industry. With Denise Smart, he manages Smart Consulting Group. Visit their blog at www.smartconsultinggroup.com/blog
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