| tter how well prepared you may be for an FDA | | | | ALL OF THE INSPECTOR’S QUESTIONS: |
| Preapproval inspection…when the moment | | | | Watch your manners, too. Never engage in an |
| comes, a lot of things can go wrong just because | | | | argument with an inspector and definitely avoid |
| you didn’t pay much attention to human | | | | arguments between peers in front of him. These will |
| factors. | | | | create a terrible impression, and you’ll regret |
| Having an inspection of your processes and premises | | | | it later. If you don’t understand something, |
| does not mean the FDA is against you and that they | | | | kindly ask for an explanation. He’ll be more |
| are going to destroy all your plans and projects. | | | | willing to explain even sections of regulations if he |
| Therefore, dealing with the corresponding inspector | | | | notices you respect his job. |
| shouldn’t be a worrisome experience for you | | | | 4. DON’T WAIT UNTIL THE LAST MINUTE |
| and your workers, nor should it be an occasion to | | | | TO PRODUCE EVERY DOCUMENT. Providing all |
| treat people badly. As advised by most | | | | documents in a timely manner will cause a good and |
| pharmaceutical consultants, organizing things in | | | | professional impression. If you can’t find a |
| advance will save you a lot of anxiety prior to the | | | | specific record, never tell the inspector that it is |
| inspection and will prevent you from making a lot of | | | | unavailable; just tell him that you can’t locate |
| silly mistakes. | | | | it. Remember he’ll be checking your cGMPs, |
| The following list contains a set of tips to bear in | | | | so handling every document request with care is also |
| mind when dealing with inspectors during their visit. | | | | important. |
| First, they will help you keep focused on the best | | | | 5. ATTEMPT TO CLARIFY OR CORRECT |
| attitude throughout the inspection, in order to make | | | | MISUNDERSTANDINGS OR ASSUMPTIONS: Never |
| it a smooth, less distressing experience. They will also | | | | guess what the inspector is thinking. If you |
| allow you to present a better, more professional | | | | encourage him to discuss his observations at the |
| image that will certainly count at the moment of | | | | moment they are performed, you’ll have |
| evaluating your application. | | | | more chances to clarify any misunderstandings or |
| 1. ESCORT THE INSPECTOR AT ALL TIMES: Never | | | | correct any information that may be mistaken. |
| leave him alone wandering around the building trying | | | | Don’t volunteer information; provide full and |
| to find things by himself. He is visiting your plant of | | | | complete answers. Don’t go beyond that |
| excellence, so give him an appropriate tour and limit | | | | point. |
| his access only to records, facilities, and materials | | | | Though it is not possible to guarantee success in |
| subject to inspection. Remember to act in a | | | | your FDA Preapproval inspection, preparing in |
| courteous and professional manner all the time. | | | | advance will certainly help you and your people feel |
| Aggressive behavior just because he happens to be | | | | less anxious at the crucial moments. Organization and |
| an inspector will not help you at all to have better | | | | respect are also key elements to bear in mind when |
| results. | | | | facing this type of experience. Follow the advice of |
| 2. LET ALL OF THE INSPECTOR’S | | | | an appropriate consultant in the pharmaceutical area |
| REQUESTS GO THROUGH YOUR INSPECTION | | | | to present your application in the best way but also |
| TEAM: Remember to assign clear roles prior to the | | | | to face this inspection. Don’t torture yourself |
| inspection. Everybody in the team should know what | | | | by improvising the inspection visit. You already have |
| is going on and what their task is at a specific | | | | the best product and the best plant…and you |
| moment. If everybody is clear on what papers are | | | | follow the best cGMPs, why spoil the impression with |
| being analyzed, there is a better chance of | | | | the wrong attitude? Mind your manners and |
| foreseeing and preventing any mistakes. | | | | everything will be fine. |
| 3. BE HONEST AND DIRECT WHEN ANSWERING | | | | |