In the last decade, the US Food and Drug Administration (FDA) issued consent decrees against several large pharmaceutical
manufacturers because of serious quality and compliance issues. In most cases, the FDA cited fundamental failures in the quality
system and the management of those systems. The impact of these compliance problems goes beyond the financial penalties and
costs of litigation. They threaten patient safety, jeopardize the company's credibility with regulatory agencies, and damage
its reputation with the public. For years, regulators have issued observations that cited specific failures of the quality
organization representatives. Now, the regulators are stating that it is the role of the executive management, not solely
the quality organization, to ensure compliance by providing leadership to the organization.
In the ICH Q10 guidline, Pharmaceutical Quality Systems, regulators clearly identify senior management as having the ultimate responsibility for ensuring the implementation of effective
pharmaceutical quality systems, and for defining, communicating, and implementing system responsibilities throughout the company.1 Senior management includes individuals who have the authority to establish a quality system, approve changes, and assign
prioritization of workloads, as well as those who have financial authority to allocate capital and human resources. In other
words, executives. The regulators are stating that the executives' role is not only to ensure the financial health of the
company, but also compliance, and ultimately, patient safety. Compliance is a fundamental responsibility that cannot be delegated.
TURNING RESPONSIBILITY INTO ACTION
Once executives understand their responsibility for ensuring quality compliance, how can they take action? There are five
key practices that successful executives follow:
1. Express a clear vision. Engaged executives express a clear and compelling vision for the organization. They play a key role in designing the quality
program and showing how it ensures business excellence.
2. Use processes to drive compliance. Efficient executives clearly define processes, create procedures, and ensure that they are followed.
3. Provide sufficient resources and set priorities. Sufficient resources in equipment, facilities, and qualified personnel must be readily available to execute the quality
program. Because time and resources are finite, however, effective executives set priorities that balance routine operations
with continuous improvement projects. They also monitor resources regularly to ensure they meet the organization's needs.
4. Establish performance metrics and monitor them continuously. Successful executives make sure that a solid system is in place to collect, analyze, and report on key drivers of business
and compliance excellence. They use the results to design and implement process improvements as needed.
5. Establish clear expectations. Effective executives make sure that the organization has a set of standards that clarify and document values and expected
behaviors, and help employees maintain quality over time.
According to the regulators, an effective quality program under engaged executive leadership and management is the solution
to ensuring patient safety and meeting compliance needs. Executives who want to succeed and avoid the risks of noncompliance
will embrace these ideas and boldly lead their organizations into the future.
Marta Jimenez-Aquino is a vice president, David W. Husman, PhD, is a principal consultant, and Thomas Feyerabend, Jr., is a principal consultant, all at PAREXEL Consulting, Lowell, MA, 978.275.0062, firstname.lastname@example.org
1. International Conference on Harmonization. Q10, Pharmaceutical quality systems, draft guideline, step 2 version. Geneva,
Switzerland; 9 May 2007.