A Quality Culture Can Be the Industry's Core Strength

Years ago, a United States congressman visited one of our manufacturing plants in New York. After touring the facility and meeting the highly experienced professionals dedicated to drug development and production, he understood the measures necessary to ensure that high quality products are manufactured each and every day. He went on to support legislation involving pharmaceutical quality and compliance issues.

Mary Oates

Although such a tour would be impractical on a large-scale basis, the pharmaceutical industry must educate the public about the extensive measures it takes to ensure product quality, maintain the integrity of the supply chain, and protect the health of patients.

As it stands now, when the topics of quality and compliance arise, they often are greeted with a collective groan. Rather than being viewed as core strengths in the industry, all too often such measures are seen as necessary evils that routinely create obstacles to their end goal.

Quality, however, also is an inherent expectation of the public. Yet, consumers and payers alike often fail to appreciate the vital role a focus on quality plays in drug development, manufacturing, and dispensing—that is, of course, until a case of poor control, such as the recent recall of low-dose swine flu vaccinations, makes headlines.

The value of an uncompromising quality culture cannot be stressed enough. In ethical and conscientious pharmaceutical organizations, a focus on quality is an integral requirement in all phases of the product lifecycle, from discovery to development and continuing through the commercial lifetime of all products. Education about the expertise, equipment, systems, and other resources required to ensure products are of high quality must be a part of the pharmaceutical industry's mission, ensuring that the general public is aware of the investment necessary to protect patient health and safety.

In addition, a strong quality focus must be evident in any business partner, contractor, or supplier with whom a pharmaceutical firm deals to prevent situations such as the recent contamination of heparin. Top leadership at all involved organizations must be confident that there are processes in place that rally representatives from various disciplines and leverage their collective talent should a problem arise. Continuous improvement, ongoing training, a science-based decision process, compliance with all regulations, and quality audits of business partners are not just an obligation of the pharmaceutical company, but of all participants throughout the supply chain.

Individual articles such as this help the effort to educate the public, though we cannot rely on this alone. The industry needs to create a public education campaign that delivers the message to a broad audience. Forums need to be created where quality and compliance can be discussed, encouraging the public to have an open dialogue directly with industry representatives.

If the public gains a better understanding of the emphasis that must be placed on product quality throughout the lifecycle of a pharmaceutical product and the resources required to do this, they also will appreciate the value of products brought to market by conscientious organizations. It is the industry's responsibility to make this happen.

Mary Oates is the vice president of Gobal Quality Operations at Pfizer Inc, New York, NY, 908.901.8095, mary.oates@pfizer.com