How Independent Audits Help Ensure Compliance and Protect the Drug Development Program

  • November 1, 2017

You live and operate in a regulated industry.

Accordingly, your entire drug development program is overseen and reviewed by the FDA, and the success of your program depends upon compliance with the Agency’s regulations. A successful outcome is determined by whether you have followed the plans detailed in your regulatory strategy, as well as the commitments you have made to the FDA.

It’s all about meeting the standards and expectations of a regulated industry.

Why Independent Audits?

Fundamentally, audits seek to answer the question, “Are you doing all of the right things?” One of the major reasons why you would want to conduct audits is to uncover issues and fix them before the FDA finds them. Proactively finding and correcting any potential issues also helps keep the product’s development on track, thus protecting your drug development program.

So, why conduct independent audits? Independent audits are specifically designed to give you a fresh and unbiased look into the quality systems associated with your program.  Most importantly, it is the objectivity inherent in an independent audit that establishes the ultimate value. Obviously, if a party associated with the program conducts the audit, that party may overlook or even downplay important issues because it may be in their interest to do so.

For instance, many contract research organizations (CROs) also conduct audits. While it may be convenient for the sponsor to have the CRO conduct an audit as a part of its services, it is not a good idea because the CRO would be auditing themselves. The CRO has an interest in the outcome of the audit and, therefore, cannot be completely objective.

Ensuring Regulatory Compliance

It is important that your contract vendors are acting in accordance with all FDA regulations. A third-party independent audit of clinical and manufacturing contract vendors is one of the best ways to ensure regulatory compliance.

Again, it’s all about meeting the standards and expectations of a regulated industry.

Safeguarding Your Investment

As you know, your entire drug development program can cost tens of millions of dollars while taking place over several years. That’s a huge investment in money and time. As such, if one of your clinical or manufacturing vendors gets something wrong and you don’t know about the mistake until it is uncovered by the FDA, it becomes a huge and costly problem.

Having the FDA discover gaps in any one of your vendor’s quality systems is exactly what you don’t want to happen. That’s because when this happens, the FDA can order remedial actions or invalidate the entire trial. This means, at the very least, you will need to spend money that you haven’t budgeted to take corrective actions. In the worst-case scenario, you risk losing your entire investment.

On the other hand, when you call on an independent auditor to audit your clinical and manufacturing contract vendors, you are safeguarding your investment. By identifying problems before the FDA does, you are taking important steps towards staying in compliance and protecting your drug development program.

Protect Your Drug Development Program with Our Help

To help ensure compliance with FDA regulations and protect your drug development program, turn to The Weinberg Group. Experienced professionals conduct our independent audits with the highest levels of accuracy and consistency. This means you can count on us to help you safeguard your investment by determining whether your clinical and manufacturing contract vendors are maintaining optimum quality systems.

Contact us today to learn more about our independent audit services.