From the Editor: Only Connect!

By Agnes Shanley, Editor in Chief

"Only connect! ...Live in fragments no longer," said a character in E.M. Forster’s novel, "Howard’s End," enjoining us to connect the emotional and the rational aspects of our human nature. In the individual, failure to connect manifests itself in personality disorders. In the pharmaceutical industry, it is evident in 483s, consent decrees, recalls, lawsuits, and stories of multi-million-dollar IT platforms being scrapped and replaced in three years.

And yet, one would be hard pressed to find a drug company that’s not officially doing "total quality management." Many of you are incorporating Six Sigma or Lean principles into your work each day. Some of you are also using, or at least thinking about using, process analytical technologies (PAT). But, at times, I wonder how synchronized all these different efforts are, at your facilities, your companies and within the industry.

Ironically, some of the drug companies that have received 483s, warning letters, or signed consent decrees this year, are leaders in implementing Lean and other Operational Excellence programs and utilizing tools such as PAT.

So, apart from the occasional fluke, how can such inconsistencies exist? Perhaps because industry professionals are now struggling to define quality, like the blind men attempting to describe the elephant in the old Indian parable. Some may cling, stubbornly, to old-fashioned notions of "tested in" quality. Others may see quality in terms of manufacturing efficiency, without making a strong enough connection back to the customer. Still others may focus too narrowly on one set of tools, such as PAT, as defining quality. That’s not a holistic enough view, as FDA’s Helen Winkle, Director of CDER’s Office of Pharmaceutical Science and PAT Team leader, recently reminded the industry.

Not surprisingly, then, there’s a lot of buzz surrounding the term "Quality by Design" (QbD), the subject of this month’s cover story. Adopting QbD requires developing a knowledge of your processes, both pharmaceutical and work processes, and applying some of the principles outlined in the Toyota Production System, not just in manufacturing but throughout the pharmaceutical life cycle, from R&D through distribution and marketing.

The term quality by design was coined by Joseph Juran, now over 100 years old, who focused on the human aspects of quality management, and who was influenced by anthropologist Margaret Mead, among others. People are the key to advancing the concept. But, for every advocate within the industry today, you may find three who dismiss it as a management fad.

We’ve been privileged to look at some of pharma’s most outstanding QbD and Operational Excellence programs. Without reducing unique projects to one warm and fuzzy blur, the teams that drive enduring quality programs appear to agree, tacitly, to:

• Define what is truly important and will yield the most benefit, and focus only on that (until a new set of priorities is developed);



• Figure out what information will be needed to achieve these goals;



• Create that information out of the deluge of data around them, ensuring that it is correct, relevant and accessible to all who need it;



• Consider all the things that can possibly go wrong, using techniques such as Failure Modes and Effects Analysis (FMEA).

This agreement can only exist in a “culture of connections,” where crossfunctional teamwork is the rule, diverse databases are linked, and connections between R&D, manufacturing, distribution and marketing are leveraged.

Does that type of culture exist at your facility or organization? If not, you may be just the one to make it happen. For our part, we promise to bring you as many inspiring, and detailed, examples as we can, from around the world, to help you in your efforts.

Only connect! The results may surprise you.