While the implementation of Six Sigma has become prevalent across many different industries, pharmaceuticals is one where there has been little adoption of the methodology.

That’s a missed opportunity for the industry, according to a recently published paper in the International Journal of Pharmaceutics.

Written by two researchers with the federal Food and Drug Administration – Lawrence X. Wu and Michael Kopcha – the report argues that the pharmaceutical industry is long overdue for the kind of improved operational efficiencies and better quality products and services that Six Sigma can produce.

“Consumers and patients deserve Six Sigma quality pharmaceuticals with minimal risks of shortages or recalls,” the pair wrote in their report. “We propose that the future of pharmaceutical quality is Six Sigma, meaning that no more than 3.4 defects occur per million opportunities.”

That number, 3.4, is the one those who implement Six Sigma hope to achieve.

A Challenging Path

Wu and Kopcha acknowledge from the outset that the path they describe in the report is “challenging.” However, they intend the report to be thought-provoking and hope it will begin a conversation in the pharmaceutical industry about the benefits of Six Sigma.

Generally speaking, Six Sigma provides an array of strategic, proven tools that when successfully implemented can help an organization identify waste in a process, develop solutions to correct it and monitor the effectiveness of the change.

The ultimate goal is to both cut wasted effort and costs while also improving the final product or service.

In the case of the pharmaceutical industry, the report identifies the ultimate goal as “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”

Not Standard Procedure

In an interview with Pharm Tech, Wu said that Six Sigma has not been implemented in the pharmaceutical industry because the focus for leaders in the field has been on developing new drugs, not on improving operational efficiencies and manufacturing processes.

There also has been little financial incentive to make improvements in these areas, partly because consumers are not always able to recognize quality or the lack thereof in pharmaceutical products.

He outlined five areas that will drive implementation of process improvement in the industry:

  • Performance-based regulation by the government
  • Economy drivers to produce quality products
  • Adopting quality by design, a strategy that involves designing systems from the start that take into account innovation and the highest quality standards
  • Implementing advanced manufacturing technologies
  • Adopting methodologies, such as those found in Six Sigma, for continuous improvement and excellence, rather than making compliance with government regulations the goal

Potential Roadblocks

In the last bullet point, the report hits on one of the issues facing the pharmaceutical industry. Because the drug-producing industry is so heavily regulated, many companies have placed the primary focus on passing government clinical trials and complying with regulations for producing and selling pharmaceuticals.

Moving past that mindset could prove problematic, Yu said in the interview. However, doing so will not only make drug makers more efficient, but also provide better quality treatment for patients.

Government regulators also play a role, the report notes. Regulations need to be written in such a way that companies feel they have the freedom for innovation, which is not always currently the case.

As with all industries, Yu said the most important first step in implementing Six Sigma is a total commitment to the methodology and for creating a culture of quality.

“This culture requires consistent senior management support and clearly communicated vision, values, and quality goals,” he said.

And, as always with process improvement in the healthcare sector, he added that the focus should always be on creating the best possible health outcomes for patients.

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