KNOW WHERE YOU ARE!

In today's regulatory climate, it is critical to know one's state of compliance at all times. FDA inspections are geared to evaluate a firm's cGMP compliance at the time of the inspection. Since FDA inspections are unannounced, the importance of being in a state of compliance at all times is quite obvious.

One way of assuring compliance is through the process of auditing. This includes internal as well as external audits. While internal house audits are certainly useful as a compliance tool, it is also very important to have a third party conduct audits of your facility on at least a yearly basis.

Third party audits provide an unbiased, "new eyes" look at a firm's compliance, and may uncover problems that would otherwise be missed during in-house audits. In terms of impact on the outcome of FDA inspections, third party inspections are well worth the cost.