| Like it or not, if your business is involved with the | | | | Inspector and prepare thoroughly, than to not be |
| FDA in any way, sooner or later, you will run into an | | | | prepared and fail the inspection. |
| inspection. A surprise audit. And if you're not | | | | The outcome of an audit may vary depending on |
| prepared, your company could be seized, penalized, | | | | many circumstances, and observations may be taken |
| or even brought up on charges. Getting an FDA | | | | out of context by the auditor. In event of this |
| inspection is no small thing, but if you make the right | | | | occurring you should have someone there with you, |
| preparations your successful FDA audit will become a | | | | taking notes down of everything the Inspector |
| reality. | | | | observes, says, and does. It is important to have a |
| One of the first things you want to do is prepare | | | | note taker there during the inspection in case |
| yourself and your company. If the inspection is | | | | anything gets taken out of context, and or, is |
| happening next week, then no last minute | | | | disputed. A good record will allow you to be able to |
| preparations will suffice, you need to condition your | | | | double check the circumstances surrounding the |
| company over the long term. You need to prepare | | | | observation, giving you the ability to make a |
| well in advance so that your company has enough | | | | successful dispute in case of severe disagreement. |
| time to be in order, efficiently and effectively. One of | | | | Your note taker should be someone who is very |
| the first things you can do is hire a pharmaceutical | | | | knowledgeable about the particular field, and is very |
| consultant who can administer Mock FDA audits to | | | | familiar with the requirements, as well as the |
| thoroughly prepare your company for an audit. This is | | | | procedures. |
| the recommended practice, but there are other | | | | An FDA field inspection can be a good thing for your |
| preparations your company can make in case of an | | | | business if you follow the correct procedures and |
| audit. | | | | prepare your staff accordingly. By conducting several |
| When preparing for an FDA inspection you should | | | | mock audits, and hiring an outside consulting firm to |
| take some time and familiarize yourself with the | | | | assist you in the process, there is no reason your |
| Agencies procedures. Knowing what questions will be | | | | company shouldn't be prepared. Remain calm, and |
| asked in advance allows you to prepare your | | | | remain confident that if you prepare your company |
| answers ahead of time, giving you an immediate | | | | and condition them the right way, then you should |
| advantage. Doing some preparation will familiarize | | | | pass your FDA audit with little difficulty. |
| yourself with the process and enable you to feel | | | | If you enjoyed this article about an pharmaceutical |
| confident and in control. When preparing for an audit, | | | | consultant , please feel free to post it to your site or |
| always assume that there will be a seasoned and | | | | blog and forward this link to to your friends. Have a |
| experienced auditor doing the inspection and that you | | | | great day! |
| must be ready. It's better to overestimate the | | | | Don't forget to visit our blog. |