The inspection by FDA investigators sounds scary if your own internal auditing processes are weak and faulty. But, to understand FDA procedures and how to successfully pass their audits, you need to first understand the role of FDA investigators. The job of the FDA is to make sure the health of the common people is protected. It’s also their responsibility to ensure that the products launched in the market are effective and safe for the people to use and that there are no probable side effects of any new drug developed.
So, it’s obvious that their focus is upon sanitation, purity, quality, and a particular identity of the drug being developed. It also reflects why GMP or good manufacturing process has acquired so much importance for the FDA. There must not be any violation of the Food and Drugs Act. Furthermore, they are also supposed to make sure that no counterfeit or diverted drug is sold in the market.
Start your own auditing
However, you need not be scared of an FDA audit as there are simple ways you can improve the quality of your processes. The first such step is to start your own auditing. Your internal auditors can take charge and start monitoring the processes. They should not be restricted to making recommendations. In fact, they should be authorized to change processes. Senior managers should also be kept in the loop to improve processes and to make sure that corrective steps are taken well in time and according to the schedule.
Internal auditing processes are very effective in improving the overall processes. You can hire third-party auditors from outside to make sure that the teams are exposed to severe mock audits. This works both ways: it brings you the complete analysis of the procedures and performance of your company; and it also works well for the training of your teams for the actual formal audit.
Don’t underestimate the experience and skills of third-party auditors as far as their ability to improve your procedures is concerned. It goes beyond passing the audit. Their inputs and tips can provide you a good insight into the prospects of your company to grow into a more successful organization.