How to Prepare Your Company For FDA Audits

by Nigel Smart

Posted on Monday 14th of September 2009


Like it or not, if your business is involved with the FDA in any way, sooner or later, you will run into an inspection. A surprise audit. And if you’re not prepared, your company could be seized, penalized, or even brought up on charges. Getting an FDA inspection is no small thing, but if you make the right preparations your successful FDA audit will become a reality.

One of the first things you want to do is prepare yourself and your company. If the inspection is happening next week, then no last minute preparations will suffice, you need to condition your company over the long term. You need to prepare well in advance so that your company has enough time to be in order, efficiently and effectively. One of the first things you can do is hire a pharmaceutical consultant who can administer Mock FDA audits to thoroughly prepare your company for an audit. This is the recommended practice, but there are other preparations your company can make in case of an audit.

When preparing for an FDA inspection you should take some time and familiarize yourself with the Agencies procedures. Knowing what questions will be asked in advance allows you to prepare your answers ahead of time, giving you an immediate advantage. Doing some preparation will familiarize yourself with the process and enable you to feel confident and in control. When preparing for an audit, always assume that there will be a seasoned and experienced auditor doing the inspection and that you must be ready. It’s better to overestimate the Inspector and prepare thoroughly, than to not be prepared and fail the inspection.

The outcome of an audit may vary depending on many circumstances, and observations may be taken out of context by the auditor. In event of this occurring you should have someone there with you, taking notes down of everything the Inspector observes, says, and does. It is important to have a note taker there during the inspection in case anything gets taken out of context, and or, is disputed. A good record will allow you to be able to double check the circumstances surrounding the observation, giving you the ability to make a successful dispute in case of severe disagreement. Your note taker should be someone who is very knowledgeable about the particular field, and is very familiar with the requirements, as well as the procedures.

An FDA field inspection can be a good thing for your business if you follow the correct procedures and prepare your staff accordingly. By conducting several mock audits, and hiring an outside consulting firm to assist you in the process, there is no reason your company shouldn’t be prepared. Remain calm, and remain confident that if you prepare your company and condition them the right way, then you should pass your FDA audit with little difficulty.

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